A denigration curve to delineate the spread of communication about obstetric staff errors in Italy and its practical application.

Background: Mistrust of doctors and the desire for compensation are driving a rise in malpractice litigation worldwide. Aim: To estimate the extent to which Italians view birth complications as malpractice in obstetric care, and how widespread this perception is. Method: WhatsApp® and Facebook® contacts of one of the authors were invited to respond to an online questionnaire. The answers of 265 Italian respondents were used to estimate how common the perception of obstetric staff errors is and how this perception spreads over time: the denigration curve. To test if the denigration curve is reliable, the curve has been plotted along with the trend of the rate of litigation in Italy. Results: Almost a 50% of respondents deemed that birth complications are due to obstetric staff errors. The likelihood of the percep-tion that one has experienced a birth complication was 64.5%. The communication of obstetric staff error seemed low overall among the respondents. The denigration curve shape is almost coincident with the curve of claim rates in Italy, proving that it would be reliable. Conclusion: The respondents provided an estimate of the rate of birth complications that was higher than the real occurrence rate, and attributed these complications to obstetric staff errors. The denigration curve could predict whether and when there might be litigation related to any birth complications (both error related and non-error related).

Medical ethics questions of COVID-19 vaccination in pregnant and lactating women in East Asia and Oceania.

Abstract: We aimed to investigate some of the medical ethics issues that characterize the COVID-19 vaccination phase in pregnancy and breast-feeding. A literature search was conducted using PubMed, Scopus, Web of Science, focusing mainly on the countries of East Asia and Oceania. Vaccination during pregnancy and breastfeeding appears to help protect babies from COVID-19 by enabling antibodies to pass from mother to baby. However, individual countries of the same continent may adopt conflicting policy positions. Not only that, indications on the type of vaccine sometimes vary, depending on whether a woman is pregnant or breastfeeding. In this review we have taken into considerationp the policy positions on pregnancy and lactation by country and type of Covid-19 vaccine in East Asia and Oceania. Ten out of the 18 countries considered (representing more than two thirds of the population of East Asia and Oceania) provide different vaccine indications for pregnant and breastfeeding women. Can this diversity of recommendations be seen as a form of optimal protection for women in these categories, or does it suggest that some countries have taken a defensive position to avoid compensation claims in the event of complications? Is it ethically correct to leave questions concerning informed consent open? Misin-formation during a health crisis leaves people without protection and with increased vaccine hesitancy, especially for vulnerable populations in hard-to-reach areas of East Asia and Oceania.

Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort.

PURPOSE: To investigate the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the somatropin biosimilar Omnitrope®. METHODS: PATRO Children is an ongoing, multicenter, observational, post-marketing surveillance study. Children who received Omnitrope® for any indication were included. Adverse events (AEs) were evaluated in all study participants. Auxological data, including height standard deviation scores (HSDS) and height velocity standard deviation scores (HVSDS), were used to assess effectiveness. In this snapshot analysis, data from the Italian subpopulation up to August 2017 were reported. RESULTS: A total of 291 patients (mean age 10.0 years, 56.0% male) were enrolled at 19 sites in Italy. The mean duration of Omnitrope® treatment was 33.1 ± 21.7 months. There were 48 AEs with a suspected relationship to the study drug (as reported by the investigator) that occurred in 35 (12.0%) patients, most commonly headache, pyrexia, arthralgia, insulin-like growth factor above normal range, abdominal pain, pain in extremity and acute gastroenteritis. There were no confirmed cases of type 1 or type 2 diabetes; however, two patients (0.7%) had impaired glucose tolerance that was considered Omnitrope® related. The mean HSDS increased from - 2.41 ± 0.73 at baseline (n = 238) to - 0.91 ± 0.68 at 6.5 years (n = 10). The mean HVSDS increased from - 1.77 ± 1.38 at baseline (n = 136) to 0.96 ± 1.13 at 6.5 years (n = 10). CONCLUSIONS: In this sub-analysis of PATRO Children, Omnitrope® appeared to have acceptable safety and effectiveness in the treatment of in Italian children, which was consistent with the earlier findings from controlled clinical trials.

Safety and effectiveness of Omnitrope® in patients with growth hormone deficiency: snapshot analysis of PATRO Adults study in the Italian population.

PURPOSE: PATRO adults is an ongoing, multicenter, observational, post-marketing surveillance study aimed at investigating the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the recombinant human growth hormone (rhGH) Omnitrope® during routine clinical practice. This report describes data from Italian participants in PATRO Adults with growth hormone deficiency (GHD), up to August 2017. METHODS: Participants were adults (aged > 18 years) with GHD requiring rhGH therapy and were prescribed Omnitrope®, including those who had previously received another rhGH product. Adverse events (AEs) were evaluated in all study participants. Data were collected on insulin-like growth factor (IGF)-I levels and cardiovascular risk factors, including blood pressure, lipids, and anthropometric parameters. RESULTS: From September 2007 to August 2017, 88 patients (mean age 48.9 years, 58.0% male) were enrolled at 8 sites in Italy. The mean treatment duration with Omnitrope® was 51.5 ± 37 months. AEs occurred in 54 patients; the most common were asthenia (20.5%), headache (14.8%), and arthralgia (13.6%). Serious AEs occurred in 22 patients (25%), including pneumonia (n = 2) and renal failure (n = 2). Neoplasms (2 benign and 1 malignant) developed in three patients, but none were considered to be drug-related. There were no significant changes in fasting glucose or glycosylated hemoglobin (HbA1c) during the study period. Long-term Omnitrope® therapy showed slight positive effects on lipid profile, while no significant changes were observed in body weight and BMI during the study. CONCLUSION: This snapshot analysis of Italian participants in PATRO Adults confirmed the long-term safety and effectiveness of Omnitrope® in adults with GHD.

The tip of the iceberg of colorectal perforation from enema: a systematic review and meta-analysis.

BACKGROUND: Although rare, perforation following an enema used to treat constipation is a dangerous complication. However, no recommendations or guidelines for enema use are available. So, in common clinical practice, the diagnostic approach and the treatment are not standardized. In an attempt to resolve this clinical dilemma associated with high mortality and potential medicolegal claims for malpractice, we have performed a systematic review and meta-analysis of studies reporting on colorectal perforation secondary to enema use for adult patients with constipation. METHODS: A systematic search of PubMed, Web of Science and Scopus was performed according to the PRISMA statement up until February 2020. Studies that reported on colorectal perforation from enema use in adult patients with constipation were included. The primary outcomes were the rate of hospital mortality and pooled prevalence estimates of mortality from perforation secondary to enema use. The secondary outcomes were the administration of rectal enemas, site of visceral perforation, signs, symptoms, radiological evaluation, and type of treatment RESULTS: A total of 15 studies were included in the final analysis (49 patients). Across all studies, the pooled prevalence estimate of mortality for patients with perforation secondary to enema use was 38.5%, (95% CI [22.7%, 55.5%]). This rate was lower in patients who had surgery (35%) than in patients treated conservatively (57.1%). The sites of perforation were intraoperatively reported in 84% of cases, but in 16% of patients the rectal perforation was undiagnosed, and surgical decision making was problematic. The primary location of the perforation was the rectum in 80.9% of the patients. The enema was administered by a nurse in 90% of the cases, self-administered in 7.5% and a family doctor in 2.5%. The main objective of emergency surgery in this setting is resection of the perforation caused by the enema; when it is not possible to resect the perforated rectum, faecal diversion is needed. Hartmann's procedure was most commonly performed by the surgeons in this review (60.7%), with other reported treatments included a diverting proximal loop colostomy and sigmoid segment exteriorization CONCLUSIONS: Considering the studies available, it is not possible to undertake a thorough evaluation of enema use, including the associated complications and their management. Further data are required to allow the development of guidelines to advice on safe enema use and management of complications.

Infliximab in Crohn's disease: early and long-term treatment.

The natural history of Crohn's disease is characterized by a remitting and relapsing course that progresses to complications and surgery in the majority of patients. Current treatment guidelines advocate a stepwise approach according to disease location and severity at presentation, with goals mainly aimed at inducing and maintaining clinical remission. Major advances in the understanding of the pathogenesis of Crohn's disease offered significant opportunities for the development of new therapies over the past years. Infliximab and other biologic agents have shown impressive results in Crohn's disease patients refractory to standard therapy, suggesting a potential disease course-modifying action. These led to the proposal to reverse the traditional therapeutic algorithms using these agents early in the course of the disease. Preliminary data suggest that early intervention may be a more effective treatment strategy in some Crohn's disease patients. As yet, early and indiscriminate use of biologics remains to be supported by convincing evidence. Data on long-term treatment of Crohn's disease with infliximab or other biologics are even more scarce. Future studies aimed to identify predictors of complicated disease and long-term randomized studies aimed to compare "step-up" and "top-down" strategies in high-risk groups should help to answer if early introduction of biological therapy alters the natural history of Crohn's disease.

Hydrogen peroxide-related colitis (previously known as "pseudolipomatosis"): a series of cases occurring in an epidemic pattern.

We report several cases of hydrogen peroxide-related colitis that occurred in an epidemic pattern in our gastrointestinal endoscopy center during a 2-month period in early 2007. During colonoscopy using sterilized endoscopes that had been flushed with hydrogen peroxide after the peracetic acid cycle, instantaneous effervescence and blanching (the "snow white sign") were observed on the intestinal mucosa when the water button was depressed. Biopsy specimens revealed features resembling a clinical condition which used to be known as "pseudolipomatosis." At follow-up, no patient was found to have suffered morbidity associated with this peroxide colitis. Endoscopists should consider hydrogen peroxide colitis when they see a snow white sign during colonoscopy which cannot be attributed to active inflammation or organic disease of the digestive tract.

The influence of endoscopic biliary stents on the accuracy of endoscopic ultrasound for pancreatic head cancer staging.

BACKGROUND AND STUDY AIMS: Biliary stents have been found to interfere with endoscopic ultrasound (EUS) tumor (T) and nodal (N) staging in patients with periampullary cancer. Our aim was to determine whether this also occurs in patients with pancreatic head cancer. PATIENTS AND METHODS: We studied a consecutive series of patients who were undergoing preoperative EUS for diagnosis and staging of suspected pancreatic cancer, some of whom had biliary stents in situ and some of whom did not. The main end point was the uni- and multivariate association of biliary stenting with T and N mis-staging by EUS. The surgical T and N stages were used as gold standards. RESULTS: A total of 65 patients were identified (19 with biliary stents in situ and 46 without). Surgical stage T4 was found more frequently in patients with stents (53% vs. 22%, P = 0.014). The T stage by EUS was correct in 85% of the patients without biliary stents and in 47% of the patients with stents. The frequency of mis-staging by EUS was significant only among patients with a biliary stent. The distribution by EUS N stage did not differ significantly from the surgical N-stage distribution in the two groups of patients. According to the multivariate analysis, patients with stents were 6.55 times more likely to be incorrectly T staged (95% confidence interval [CI] 1.69-25.49) and 3.71 times more likely to be incorrectly N staged (95% CI 1.11-12.45) than patients without stents. CONCLUSIONS: The results add support to the recommendation that EUS staging of pancreatic head neoplasms should be performed prior to stent placement.

Growth hormone in inflammatory bowel disease.

Crohn's disease and ulcerative colitis are inflammatory diseases of the gastrointestinal tract characterized by chronic relapsing inflammation and catabolism. Growth hormone/insulin-like growth factor-I axis is important in inflammatory bowel disease, because of the effects on epithelial cell kinetics, collagen deposition and immunomodulation. The potential of growth hormone as a therapeutic option in inflammatory bowel disease has been proven in various clinical settings. Acquired growth hormone resistance in inflammatory bowel disease seems to be mediated by a combination of undernutrition and active inflammation. In particular, proinflammatory cytokines, such as TNF-a and interleukin-6, have been implicated as potential mediators of growth hormone resistance. The introduction of anti-TNF-alpha monoclonal antibodies has proven very efficacious in patients with inflammatory bowel disease. By reducing cytokines levels in inflammatory cells of intestinal mucosa, infliximab could interfere with cytokine-induced growth hormone resistance. Recent in vivo data have shown that acquired growth hormone resistance in patients with inflammatory bowel disease may be reversed after the administration of anti-TNF-alpha therapy.

High prevalence of hyperplastic colonic polyps in acromegalic subjects.

We evaluated the prevalence and features of colonic polyps in a population of acromegalic subjects, compared to a control group of patients with irritable bowel syndrome (IBS). Colonic polyps were found in 30 acromegalic subjects (40%) and in 10 controls (13%) (P < 0.0001). Among the acromegalic patients, polyps were of the hyperplastic type in 27 subjects (90%) and adenomatous in 3 (10%). In the control group, polyps were hyperplastic in nine subjects (90%) and adenomatous in one (10%). We also observed a significant association (P < 0.0001) between the presence of hyperplastic polyps and the older age in both the acromegalic and the control groups. There were no differences between the two groups regarding sex, site, size, or macroscopic and histological types of polyps. Acromegalic patients have a higher prevalence of colonic hyperplastic polyps than IBS subjects, while the prevalence of adenomatous polyps is similar in the two groups.

Infliximab in the treatment of steroid-dependent ulcerative colitis.

BACKGROUND AND OBJECTIVES: Infliximab has proven efficacious in the treatment of Crohn's disease. Limited and contrasting data are available on effectiveness of anti-TNF alpha therapy in ulcerative colitis. We evaluated the efficacy of infliximab in the management of steroid-dependent ulcerative colitis. METHODS: We report preliminary data from a randomized, open-label, methylprednisolone-controlled trial of infliximab in the induction and maintenance of remission of patients with moderate to severe steroid-dependent ulcerative colitis. Twenty patients received either three infusion of infliximab (5 mg/kg) at 0, 2 and 6 weeks and thereafter every 8 weeks (group A) or methylprednisolone (0,7-1 mg/kg) daily for one week followed by a tapering regimen up to the minimal dose to maintain a symptom-free condition (group B). Clinical remission was defined as a DAI score less than 3. RESULTS: Ten patients in group A (DAI: 8.9+/-1.4) achieved remission after the first infusion (DAI: 1.6+/-0,7; p = 0.005) and steroids were progressively discontinued. At present (mean follow-up: 9.8+/-1.1 months), 9 out of 10 patients maintain clinical remission, while one patient relapsed at 3 months. Ten patients in group B (DAI: 8.7+/-1.4) reached clinical remission at one week (DAI: 1.9+/-0.3; p = 0.005). Eight out of 10 patients were maintained at a minimal steroid dosage without any relapse at 9.7+/-1.0 months follow-up. Two patients relapsed at 6 and 8 months, respectively. CONCLUSIONS: Infliximab seems to be as effective as steroids in the management of moderate to severe steroid-dependent ulcerative colitis. These preliminary data suggest the potential efficacy of repeated treatment with infliximab for short-term maintenance of remission and steroid withdrawal in glucocorticoid-dependent ulcerative colitis.

Modulation of host antimicrobial peptide (beta-defensins 1 and 2) expression during gastritis.

BACKGROUND: beta-Defensins are a newly identified family of antimicrobial peptides that are expressed by epithelia on mucosal surfaces where their production is augmented by infection or inflammation. Helicobacter pylori colonises the gastric epithelium causing persistent gastric inflammation leading to antral and corpus gastritis, and peptic ulcer disease. AIMS: To evaluate the role of beta-defensins in the innate immune response of the gastric epithelium to infection and inflammation, we have assessed mRNA expression and regulation of human beta-defensins 1 and 2 (hBD1, hBD2) by H pylori and proinflammatory stimuli. We have also compared gene and peptide expression of these bactericidal agents in H pylori induced gastritis with that in normal gastric mucosa. METHODS: Modulation of expression of hBD1 and hBD2 by various stimuli was studied in three (AGS, MKN7, MKN45) gastric epithelial cell lines by quantitative competitive reverse transcription-polymerase chain reaction (RT-PCR). Defensin mRNA expression was measured by semiquantitative RT-PCR in gastritis tissue and compared with controls. Peptide localisation was assessed by immunohistochemistry. RESULTS: Cytotoxic H pylori and interleukin 1 beta (IL-1 beta) markedly upregulated expression of hBD2 in a dose and time dependent manner in both AGS and MKN7 cell lines. A modest increase in hBD1 expression was also noted during infection. Interestingly, induction of hBD1 gene expression by IL-1 beta was only observed in MKN7 cells. The magnitude of this response was delayed and reduced compared with hBD2 expression. In gastric biopsies, hBD2 was undetectable in normal gastric antrum but a marked increase was observed in H pylori positive gastritis compared with control tissue (p<0.001). Constitutive expression of hBD1 was observed in normal gastric mucosa and there was a significant increase in gastritis (p<0.05). Immunohistochemistry revealed a parallel increase in hBD1 and hBD2 peptide expression in gastritis tissue with positive staining confined to the surface epithelium of the gastric glands. CONCLUSIONS: Modulation of beta-defensin expression by pathogenic and/or inflammatory stimuli and their cellular localisation places these antimicrobial peptides in the front line of innate host defence in the human stomach.

[Myelodysplastic syndromes. Clinico-pathologic analysis of 54 cases]. / Sindromi mielodisplastiche. Analisi clinico-patologica di 54 casi.

For myelodysplastic syndromes (MDS) many scoring systems were developed to improve the prognostic stratification of patients. METHODS AND AIM OF THE STUDY: We enrolled 54 primary MDS patients, having an advanced median age of 78.5 years, that discouraged the choice of aggressive treatments. Then, we employed only the Bournemouth score (without cytogenetic analysis), with the aim to identify the best predictor of death and of AML development. RESULTS: Both for overall and leukemia-free analysis, shorter survival and faster development of AML were found in MDS patients with severe peripheral cytopenia, RAEB-T, major proportion of bone marrow blasts (over 20%) and with the higher Bournemouth score (i.e. 3-4). The multivariate analysis by the Cox's regression model showed that a high percentage of bone marrow blasts presented the best statistical significance. CONCLUSIONS: In our survey we confirmed the value of Bournemouth score in identifying those MDS patients presenting a greater risk of death and AML development. Moreover, a high percentage of bone marrow blasts rose as the best predictor of death and leukemic evolution. The kariotypic analysis, with a stronger prognostic power but also complex and expensive, was not performed in our elderly MDS patients, who were unable to tolerate aggressive treatments.

Troponin I serum concentration: a new marker of left ventricular hypertrophy in patients with essential hypertension.

BACKGROUND: Troponin I, a specific cardiac muscle protein, has proven to be very helpful in detecting myocardial damage in ischemic heart disease. In order to assess if this laboratory test may also characterize some hypertensive subjects with proven cardiac damage, we compared troponin I serum concentrations of a group of patients affected by systemic hypertension and left ventricular hypertrophy (LVH) with troponin I serum concentrations of hypertensive patients without LVH and with normal controls. METHODS: Of 100 hypertensive patients consecutively enrolled in the study, 27 had an increased left ventricular mass by M-mode/two-dimensional echocardiographic examination. Of these, 4 were excluded for significant Holter ST-segment modification. Troponin I was measured in the remaining 23, in 23 age- and sex-matched hypertensive patients with normal left ventricular mass and in 23 normal controls. RESULTS: Troponin I serum concentration was higher than the upper limit of the normal values (0.5 ng/mi) in 12 of the 23 hypertensives with LVH. On the contrary, all hypertensives without LVH and all normal controls had troponin I serum concentration below the upper limit of the normal values. Consequently, the mean troponin I serum value was significantly higher in the group of hypertensive patients with LVH than in the group of patients without LVH (0.88 +/- 0.93 vs 0.27 +/- 0.08 ng/ml, p = 0.002) and in normal controls (0.88 +/- 0.93 vs 0.22 +/- 0.04 ng/ml, p = 0.0001). CONCLUSIONS: Our data indicate that a significant proportion of patients affected by essential hypertension with LVH have slightly elevated troponin I serum concentrations. This test seems to identify two subgroups of hypertensive subjects with LVH, and, considering that troponin I is a marker of myocardial damage, higher serum values probably indicate a more important cardiac involvement in the setting of a hypertensive disease.

Unsaturated hydrocarbons with fruity and floral odors.

Hydrocarbons usually do not exhibit odors of interest or well-defined character. However, certain cyclic alkenes have been associated with typical and pleasant notes, such as fruity, green, and floral. One of the best known examples is represented by the isomeric megastigmatrienes, endowed with a pleasant smell of tropical fruits. From the structures of these odorants, 24 analogues and homologues, most of them cyclic alkenes, but including also some open-chain alkenes, have been synthesized to define structural parameters related to the characteristic odors of these compounds. The number and position of double bonds, the substitution on the ring, and the size of the ring are the variables taken into account. Most of the new compounds present a mainly fruity character, associated in several cases with floral and green notes, producing an overall sensation described as "tropical fruit".

Prevalence and early diagnosis of coeliac disease in autoimmune thyroid disorders.

BACKGROUND AND AIMS: Coeliac disease is associated with several autoimmune disorders such as insulin-dependent diabetes, Sjogren's syndrome, Addison's disease and thyroid diseases. The aim of our study was to evaluate the prevalence of coeliac disease in patients affected by autoimmune thyroid diseases by means of anti-gliadin and anti-endomysial antibodies. PATIENTS: We studied 92 patients affected by autoimmune thyroid diseases (47 chronic autoimmune thyroiditis, 22 Hashimoto's thyroiditis and 23 Graves' disease). Ninety patients with non autoimmune thyroid disorders (51 multifollicular goitre, 28 solitary nodule and 11 papillary carcinoma) and 236 blood donors also took part in the study as control groups. METHODS: Total serum IgA were measured in all subjects to exclude selective IgA deficiency; then we measured anti-gliadin antibodies and anti-endomysial antibodies. In patients with anti-gliadin/anti-endomysial antibody positivity and/or with haematinic and laboratory signs of malabsorption we carried out gastrointestinal endoscopy with duodenal histological examination. RESULTS: Among the 92 patients with autoimmune thyroid disease, 4 (4.3%) showed anti-gliadin and anti-endomysial positivity and had coeliac disease; among the 90 patients with non autoimmune thyroid diseases, 1 (1.1%) had coeliac disease; finally, among the blood donors, 1 subject (0.4%) was anti-gliadin-anti-endomysium antibody positive and had coeliac disease. Those subjects presenting with only anti-gliadin antibody positivity did not have coeliac disease. CONCLUSIONS: These results show that the prevalence of coeliac disease in patients with autoimmune thyroid diseases is significantly increased when compared with the general population (p = 0.009) but not with patients affected by non autoimmune thyroid disorders (p = 0.18). We suggest a serological screening for coeliac disease in all patients with autoimmune thyroid disease measuring anti-endomysial antibodies, considering that early detection and treatment of coeliac disease are effective in preventing its complications.

Effect of moderate and heavy alcohol consumption on intestinal transit time.

BACKGROUND: Alcohol abusers frequently have gastrointestinal symptoms, such as diarrhea, nausea and vomiting. In the genesis of these symptoms multiple mechanisms are involved, including alteration of gastrointestinal motility. The aim of our study was to investigate oro-cecal transit time (OCTT) using the H2-breath test (H2-BT) in moderate and heavy drinkers. MATERIALS AND METHODS: We studied 40 chronic drinkers: 20 with heavy alcohol consumption (> or = 60 g/day for men and > or = 40 g/day for women) and 20 with moderate alcohol intake (< 60 g/day for men and < 40 g/day for women). The control group consisted of 20 teetotal subjects. All subjects underwent a lactulose H2-BT to assess OCTT. RESULTS: OCTT in heavy alcohol drinkers ranged from 100 to 240 min, with a mean of 149.5 min, while OCTT in moderate drinkers ranged from 70 to 140 min, with a mean of 109 min. In the control group the mean OCTT was 100 mins, ranging from 70 to 130 min. The difference between alcohol abusers and controls was statistically significant; on the contrary, there was no statistically significant difference between moderate alcohol drinkers and teetotallers. CONCLUSIONS: Our study shows that only in chronic heavy alcohol drinkers is OCTT clearly increased. Multiple mechanisms are hypothesized to explain motility disorder, such as visceral autonomic neuropathy, inflammation and loss of contractile proteins of smooth muscle layer of the small intestine.

One-week therapy for Helicobacter pylori eradication: ranitidine bismuth citrate plus medium-dose clarithromycin and either tinidazole or amoxycillin.

BACKGROUND: One-week ranitidine bismuth citrate (RBC)-based triple regimens may be effective for the eradication of Helicobacter pylori. We evaluated the efficacy of two short-term RBC-based eradicating therapies including RBC plus medium-dose clarithromycin and either tinidazole or amoxycillin. METHODS: Seventy consecutive patients, who underwent gastroscopy for dyspeptic symptoms and were found to be H. pylori-positive, were randomly subdivided into two groups receiving either RBC 400 mg b.d. plus clarithromycin 250 mg t.d.s. and tinidazole 500 mg b.d. (group RBCCT) or RBC 400 mg b.d. plus clarithromycin 250 mg t.d.s. plus amoxycillin 1 g b.d. (group RBCCA). H. pylori status was evaluated by means of histology and rapid urease test at entry, and by 13C-urea breath test alone 8 weeks after treatment. RESULTS: Sixty-nine out of 70 enrolled patients completed the study: 35/35 in group RBCCT and 34/35 in group RBCCA. One patient in group RBCCA was lost to follow-up. In group RBCCT, at the end of treatment, 32 of 35 patients were H. pylori-negative (per protocol analysis 91%, intention-to-treat analysis 91%; 95% CI: 77-98%). In group RBCCA, 31 of 34 patients returned H. pylori-negative (per protocol 91%; 95% CI: 76-98%, intention-to-treat 89%; 95% CI: 73-97%). Slight side-effects occurred in 3/35 patients (9%) in group RBCCT and in 3/34 (9%) in group RBCCA. CONCLUSIONS: One-week regimens consisting of RBC plus clarithromycin and either tinidazole or amoxycillin, combine high eradication rates with modest side-effects. No substantial difference was found between the two treatment regimens tested in this trial.

Helicobacter pylori infection and ischaemic heart disease.

Helicobacter pylori infection is probably one of the most widely spread infectious diseases in man and a growing body of knowledge provides evidence in favour of a causal link between this infection and the majority of upper gastrointestinal conditions. For example, we now know that peptic ulcer disease is an infectious disease; if the infection is diagnosed and treated, ulcer can be cured. On the other hand, in recent years, a number of epidemiological studies have focused on the possible relation between ischaemic heart disease and several infectious disorders, such as chronic dental infections, Cytomegalovirus, Coxsackie viruses, Chlamydia and, finally Helicobacter pylori. The results of studies on the association between ischaemic heart disease and Helicobacter pylori have, in particular, often been contradictory, and only some studies adjusted the results for confounding factors, and the adjustment of the results in some cases modified the association. In conclusion, even if coronary atherosclerosis may now be considered as an inflammatory process, according to several histologic and pathophysiologic studies, we cannot, for the moment, be sure that it is an infectious disease.