Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial)

Objective To determine the cost effectiveness of Helicobacter pylori “test and treat” compared with empirical acid suppression in the initial management of patients with dyspepsia in primary care.Design Randomised controlled trial.Setting 80 general practices in the United Kingdom.Participants 699 patients aged 18-65 who presented to their general practitioner with epigastric pain, heartburn, or both without “alarm symptoms” for malignancy.Intervention H pylori ¹³C urea breath test plus one week of eradication treatment if positive or proton pump inhibitor alone; subsequent management at general practitioner’s discretion.Main outcome measures Cost effectiveness in cost per quality adjusted life year (QALY) (EQ-5D) and effect on dyspeptic symptoms at one year measured with short form Leeds dyspepsia questionnaire.Results 343 patients were randomised to testing for H pylori, and 100 were positive. The successful eradication rate was 78%. 356 patients received proton pump inhibitor for 28 days. At 12 months no significant differences existed between the two groups in QALYs, costs, or dyspeptic symptoms. Minor reductions in costly resource use over the year in the test and treat group “paid back” the initial cost of the intervention.Conclusions Test and treat and acid suppression are equally cost effective in the initial management of dyspepsia. Empirical acid suppression is an appropriate initial strategy. As costs are similar overall, general practitioners should discuss with patients at which point to consider H pylori testing.Trial registration Current Controlled Trials ISRCTN87644265.     

Is Helicobacter pylori associated with non-ulcer dyspepsia and will eradication improve symptoms? A meta-analysis

ObjectivesTo examine the association between Helicobacter pylori infection and non-ulcer dyspepsia, and to assess the effect of eradicating H pylori on dyspeptic symptoms in patients with non-ulcer dyspepsia.DesignSystematic review and meta-analysis of (a) observational studies examining the association between Helicobacter pylori infection and non-ulcer dyspepsia (association studies), and (b) therapeutic trials examining the association between eradication of H pylori and dyspeptic symptoms in patients with non-ulcer dyspepsia (eradication trials).Results23 association studies and 5 eradication trials met the inclusion criteria. In the association studies the summary odds ratio for H pylori infection in patients with non-ulcer dyspepsia was 1.6 (95% confidence interval 1.4 to 1.8). In the eradication trials the summary odds ratio for improvement in dyspeptic symptoms in patients with non-ulcer dyspepsia in whom H pylori was eradicated was 1.9 (1.3 to 2.6).ConclusionsSome evidence shows an association between H pylori infection and dyspeptic symptoms in patients referred to gastroenterologists. An improvement in dyspeptic symptoms occurred among patients with non-ulcer dyspepsia in whom H pylori was eradicated.     

Gastroduodenal lesions and Helicobacter pylori infection in dyspeptic patients with and without chronic renal failure

BACKGROUND: Patients with chronic renal failure (CRF) often have dyspeptic symptoms and may develop peptic disease or digestive disorders leading to severe gastrointestinal complications. The primary aim of this study was to evaluate the prevalence of peptic lesions and Helicobacter pylori infection, and the severity of dyspeptic symptoms, in dyspeptic patients with and without CRF. Our secondary aim was to investigate whether uremic status may affect the diagnostic efficiency of the [13]C-urea breath test ([13]C-UBT). PATIENTS AND METHODS: We consecutively enrolled in the study 50 dyspeptic patients with chronic kidney failure (mean age 52 +/- 5 years), of whom 11 were on hemodialysis treatment (HD), and 93 subjects (mean age 54 +/- 7 years) with chronic dyspepsia and normal renal function (NRF). All patients completed an oriented and validated questionnaire scoring the severity of nine dyspeptic symptoms (i.e. epigastric pain, epigastric burning, postprandial fullness, early satiety, bloating, belching, nausea and vomiting) and underwent upper endoscopy with multiple bioptic sampling for rapid urease test and histological examination, [13]C-UBT and HpSA test. RESULTS: The prevalences of peptic lesions and H. pylori infection and mean symptom score were 74%, 52% and 3.5 +/- 3, respectively, in dyspeptic patients with CRF and 18%, 36% and 8 +/- 5, respectively, in dyspeptic patients with NRF. The diagnostic accuracy of [13]C-UBT with respect to histological diagnosis was 94% and 97% for dyspeptic patients with and without renal failure, respectively. CONCLUSIONS: 1, A high frequency of peptic lesions and low symptom scores were observed in uremic patients in spite of H. pylori infection; 2, uremic status did not affect the diagnostic accuracy of [13]C-UBT.     

Systematic review and meta-analysis from Chinese literature: the association between Helicobacter pylori eradication and improvement of functional dyspepsia

OBJECTIVES: To evaluate the effect of eradicating Helicobacter pylori on dyspeptic symptoms in patients with functional dyspepsia in China. DATA SOURCES: Randomized controlled trials conducted in China and those published between 1989 and April 2007. REVIEW METHODS: The articles were retrieved from Chinese biomedicine Web database and Chinese scientific Journals database using proper MESH headings and assessed by two independent investigators according to established inclusion criteria. The characteristics of chosen articles were displayed for further analysis, and summary odds ratio were calculated to determine the overall effect of H. pylori eradication. All the data were entered and analyzed using REVIEW MANAGER 4.1, and p < .05 was defined as statistically significant in all analysis. RESULTS: Seven qualified trials were enrolled, and the summary odds ratio for improvement in dyspeptic symptoms in patients with functional dyspepsia in whom H. pylori was eradicated was 3.61 (95%CI: 2.62, 4.98, p < .00001). The difference in the follow-up period did not influence the final outcomes. CONCLUSIONS: An improvement in dyspeptic symptoms occurred among Chinese patients with functional dyspepsia in whom H. pylori was eradicated.     

Artichoke leave extract for chronic hepatitis C – A pilot study

BackgroundArtichoke leave extracts (ALE) have hepatoprotektive properties and are used by patients with chronic liver disease. Effects in patients with chronic hepatitis C are unclear.Methods17 patients with chronic hepatitis C and persistently elevated aminotransferase levels were treated for 12 weeks with 3200 mg standardized ALE per day. Primary outcome parameter was the rate of alanine aminotransferase (ALT) normalisation after 12 weeks. Secondary parameters were the course of ALT, aspartate aminotransferase and γ glutamyltransferase levels, quantitative HCV RNA, subjective symptoms frequently associated with chronic hepatitis C (fatigue, discomfort upper abdomen, joint problems) and safety.ResultsNone of the patients had normalized ALT levels after 12 weeks of treatment. There was no significant change of aminotransferase levels or viral load compared to baseline levels. Fatigue and joint problems significantly improved after 4 weeks of treatment. However, after 12 weeks, there was no significant difference to baseline. Tolerability of ALE was rated as good to excellent. Severe side effects did not occur.ConclusionALE seem not to be effective to improve aminotransferase levels in patients with chronic hepatitis C     

Functional dyspepsia – A multicausal disease and its therapy

Functional dyspepsia is a common chronic disorder with non-specific upper abdominal symptoms which can not be explained by organic or biochemical abnormalities. The dyspeptic symptoms are very compromising and bothersome and result in a substantial reduction of quality of life. The substantial direct and indirect medical and economical costs induce a high socioeconomic interest in the pathogenesis and the treatment options of this disease. Over the past 30 years several theories about the etiology of the symptoms in functional dyspepsia patients have been put forward. These include disorders of gastrointestinal motility, acid secretion, visceral hypersensitivity, adaptation and accommodation, Hp-infection, mucosal inflammation and finally genetic predisposition. There is increasing evidence that functional dyspepsia is a multi-causal disorder, which leads to altered processing of afferent information from the gastrointestinal tract to the CNS. Autonomic hypersensitivity and altered central processing could be a common phenomenon whereas motility changes, inflammation or altered secretion could increase neural afferent inputs. Treatment of this complex disorder could and should involve these different levels of symptom generation. Thus different approaches with anti-secretory, spasmolytic, prokinetic and anti-inflammatory effects and most preferably reduction of visceral hypersensitivity seem logical. This could explain the variety of drugs which show a positive symptomatic response. This could also offer the conclusion, whether a combination of these drugs could be clinically superior which remains to be proven. And this could offer a logical approach for the use of substances with a multi-target action, e.g. STW 5.     

Dysbiotic manifestations during eradication therapy of Helicobacter pylori and their corrections

Forty-eight patients with duodenal peptic ulcer disease infected with Helicobacter pylori were examined. All patients undergo conventional 1-week eradication therapy. After its ending the patients were randomized to two groups: those who will be treated by synbiotics or control group. Normoflorin B and Normoflorin L, which contain bifidobacteria or lactobacilli in complex with different microelements, vitamins, aminoacids, organic acids, and antioxidants, were used as synbiotics. Morphologic study of biopsy samples of small intestine mucosa were performed in patients from both groups. It was determined that eradication therapy worsened existing symptoms of dyspepsia in 80.9% of cases or lead to their emergence, connected with dysbiotic manifestations, in 55.5% of patients. Inclusion of synbiotics in complex therapy resulted in rapid and effective elimination of dyspeptic symptoms, promoted recovery of affected morphologic and functional states of small intestine mucosal epithelium, and optimized metabolic processes important for the digestion.     

Adjunctive atomoxetine to SSRIs or SNRIs in the treatment of adult ADHD patients with comorbid partially responsive generalized anxiety (GA): an open-label study

To examine changes in partially responsive anxiety symptoms utilizing adjunctive treatment with atomoxetine in the treatment of adult ADHD patients with comorbid partially responsive anxiety symptoms. Consenting adult patients (n=29) with confirmed diagnosis of generalized anxiety and comorbid attention deficit hyperactivity disorder (ADHD) participated in this open-label study. All patients had significant comorbid anxiety symptoms (HAM-A>7) and failed to respond to 8-week trials of selective serotonin reuptake inhibitors (SSRIs) or noradrenaline reuptake inhibitors (SNRIs). All patients were treated with atomoxetine as adjunctive to SSRIs or to SNRIs and were followed for at least 12 weeks. The primary outcome measure was the Clinical Global Impression severity subscale. Other scales included the Hamilton Anxiety Scale (HAM-A), the adult ADHD Self-Report Scale (ASRS-v1.1) symptom checklist, and Sheehan's Disability Scale. Baseline measures prior to the treatment with atomoxetine were compared to those at 4, 8, and at 12 weeks of treatment. Monitoring for pulse, blood pressure, and weight changes was carried out at baseline and at end point. Twenty-seven patients (93%) completed this open-label study. There was significant resolution of symptoms of all outcome measures, including the symptoms of anxiety, as shown by changes from baseline in HAM-A, ASRS-v1.1, and CGI at 12 weeks (P<.001). Also, there was significant reduction in the disability score at 12 weeks. Patients completed the study, tolerated the adjunctive treatment, and there were no significant cardiovascular or weight changes. Two patients withdrew from the study during the first 4 weeks of treatment due to side effects. Atomoxetine can be used as an adjunctive treatment in adult patients with ADHD and comorbid partially responsive anxiety symptoms.     

Choice of age cut-off for endoscopy in dyspepsia in developing countries according to incidence of gastric cancer

Endoscopic examination of all patients with dyspepsia is hard to perform, because of high annual prevalence of dyspepsia and limited resource availability, especially in developing countries. Aim was to establish age cut off for upper endoscopy in dyspeptic patients without alarming features according on incidence of gastric cancer in western Herzegovina in Bosnia and Herzegovina. Group of 2697 (1536 males, 1161 females) patients over 15 with chronic dyspepsia without alarming features and symptoms of gastroesophageal reflux disease, had been referred for a diagnostic upper endoscopy during 4 years. Study was prospective. All 34 gastric cancers were diagnosed in male patients above 55 years, and in female ones above 60. In the same age groups two thirds of gastric ulcers were found out. If the age cut off for dyspeptic patients had been 55 years for male and 60 for female gender, the workload could be decreased by 50%. The choice of alternative approaches is possible, depending on the level of diagnostic uncertainty, the patient and his physician are prepared to accept. Age cut off determines diagnostic approach in chronic dyspepsia, and greatly decreases the endoscopy workload.     

Clinical Applicability of Patient- and Clinician-Reported Outcome Tools in the Management of Patients With Acromegaly

ObjectiveWe aimed to assess treatment outcomes and disease control status in patients with acromegaly using patient- and clinician-reported outcome tools and to analyze correlations among different components of both tools.MethodsThis cross-sectional study included 72 patients from a national referral center with a median follow-up of 8 (5-12) years. The baseline SAGIT score at diagnosis was determined retrospectively, whereas the follow-up SAGIT and acromegaly quality of life questionnaire (AcroQoL) results were assessed at the most recent visit and by additional telephone interviews.ResultsAll SAGIT subscores decreased significantly from baseline to follow-up (global score from 14 to 4 [P < .001]). The SAGIT scores at baseline did not discriminate the current disease control status. However, a higher baseline SAGIT score and subscore T were associated with uncontrolled disease after the first-line treatment. Diagnostic delay was correlated with baseline S, A, G, and global SAGIT scores. At the follow-up, the global SAGIT score discriminated between cured/controlled and uncontrolled groups (4 vs 6 [P = .007]). The AcroQoL score was 69.3, with the personal relations subscale being the least affected and the physical scale being the most affected. There was no difference in the AcroQoL score between patients classified as uncontrolled or cured/controlled. At baseline and follow-up, there were significant negative correlations between S and A subscores and AcroQoL score. A higher body mass index, the presence of swelling, joint symptoms, headaches, sleep apnea, and hypertension significantly impaired quality of life.ConclusionOur results emphasize the complementary nature of the patient- and clinician-reported outcome tools in acromegaly management. We identified modifiable signs, symptoms, and comorbidities as treatment targets that might help clinicians improve quality of life in this population.