Symptoms In Functional Dyspepsia Patients Research Articles

Impact of Acotiamide Affects Meal-related Symptoms and Lower Abdominal Symptoms in Functional Dyspepsia in Japan

Background: To clarify whether acotiamide improve postprandial distress symptoms and lower abdominal symptoms through affecting hypothalamic-pituitary-adrenal (HPA) axis in FD patients. Methods: We used Rome III criteria to evaluate upper and lower abdominal symptoms. Twenty-five functional dyspepsia (FD) patients were treated with acotiamide (300mg/day) for 4 weeks. Anxiety was evaluated using STAI-state/-trait. We measured ACTH and cortisol levels in FD patients. Results: Acotiamide treatment significantly (p=0.007, p=0.003) improved postprandial fullness and early satiety in 4 weeks treatment in FD patients compared to those in pretreatment. In contrast, acotiamide treatment improved lower abdominal symptoms, while insignificantly. Acotiamide did not also affect anxiety using STAI-state/-trait. Acotiamide treatment for 4 weeks did not affect ACTH and cortisol levels in FD patients. Conclusions: Further studies will be needed to clarify how acotiamide improve clinical symptoms in FD patients.

Dyspepsia

Dyspepsia affects up to 40% of the general population and significantly reduces quality of life. A small proportion of patients have peptic ulcer disease as cause and this can be treated empirically with Helicobacter pylori eradication therapy in those that are infected. Approximately 20% have gastro-oesophageal reflux disease and this can be effectively treated with proton pump inhibitor therapy. Patients who remain symptomatic may warrant an endoscopy, but most will have functional dyspepsia. Treatment of functional dyspepsia remains a challenge. Recent large randomized trials suggest tricyclic antidepressant therapy may be effective in functional dyspepsia. A phase III randomized controlled trial reports that a new prokinetic, acotiamide, reduces dyspepsia symptoms in functional dyspepsia patients. There are also preliminary data that suggest buspirone, a drug that promotes gastric accommodation, is also effective in functional dyspepsia. There are also data to suggest that functional dyspepsia is caused by subtle manifestations of inflammation in the upper gastrointestinal tract, possibly caused by food sensitivity or a change in gut flora. The initial management of dyspepsia is well established, but managing those with continued symptoms is a challenge. Antidepressants and newer gastric motility agents show promise. Targeting the diet and gut microbiome is another area for future research in functional dyspepsia.

Tu2093 Distinction Between Gastric and Small Intestinal Symptoms After a Meal in Patients With Functional Dyspepsia

Background: Functional dyspepsia (FD) is a common disorder of gastrointestinal function characterized by chronic epigastric symptoms. Traditionally, the stomach has been held responsible for the generation of symptoms. The latest reports, however, have pointed out that also the duodenum can be implicated in the pathophysiology of FD. The aim was to analyze the time course of dyspeptic symptoms after a meal in FD patients and to elucidate which symptoms specifically originate from the stomach and/or from the small intestine. Methods: Gastric emptying rate for solids was determined in 308 FD patients fulfilling Rome II criteria (87 men, mean age 42±1 years) using the 14C-octanoic acid breath test. Breath samples were taken before a meal and at 15 min intervals for a period of 240 min postprandially. At each breath sampling, the patients were asked to grade the intensity (03) of 6 symptoms (epigastric pain, postprandial fullness, bloating, nausea, epigastric burning and belching). Gastric half emptying time (t1/2) was calculated from the breath samples to determine the gastric phase and the small intestinal phase per individual. The gastric period was defined as the time interval between time point 15 min and t1/2; the small intestinal phase was defined as the time interval between 3*t1/2 (stomach emptied 87.5%) and the end of the measurement. For each symptom, the average of the severity scores during the gastric and the small intestinal phase was calculated and compared using a paired Student's t test. Data are given as mean±SEM. In addition, time curves of each symptom were analyzed from time point 30 min until 240 min using mixed models with linear effects of time as a continuous independent variable. Results: 161 patients (49 men, mean age 43±1 years) had a t1/2,75min and hence, both a gastric and small intestinal phase during the 4h test period. Numerical analysis revealed that scores for bloating, fullness and belching were higher during the gastric phase compared with the small intestinal phase, while intensities of epigastric pain, burning and nausea were similar for the gastric and small intestinal phase (Table 1). This was further supported by the results of the time curves (Table 2). Fullness, bloating, belching and nausea displayed a significant negative slope, indicating a decrease in symptoms with progression of food from the stomach into the small intestine. Symptom severity of burning and pain showed no decrease, indicating that these symptoms persist with food moving to the small intestine. Conclusion: These data suggest that the stomach as well as the small intestine contribute to the generation of postprandial symptoms in FD patients. Bloating, fullness and belching seem to originate mainly from the stomach; while symptoms of epigastric burning, pain and nausea seem to be driven by both stomach and small intestine. Table 1

Nizatidine Improves Clinical Symptoms and Gastric Emptying in Patients with Functional Dyspepsia Accompanied by Impaired Gastric Emptying

Background/Aims: In this crossover study, we investigated whether nizatidine, a H₂-receptor antagonist, can alleviate clinical symptoms and gastric emptying in patients with Rome III-based functional dyspepsia (FD) with or without impaired gastric emptying. Methods: We enrolled 30 patients presenting with FD symptoms (epigastric pain syndrome, n = 6; postprandial distress syndrome, n = 24). Rome III-based FD patients were treated with nizatidine (300 mg/day) or placebo for 4 weeks in a crossover trial. Gastric motility was mainly evaluated with the T_max value using the ¹³C-acetate breath test. Meal-related symptoms were defined as postprandial fullness and early satiation. Gastroesophageal symptom was defined as a burning feeling rising from the stomach or lower chest up toward the neck. Acylated- and desacylated ghrelin levels were evaluated by the ELISA method. Clinical symptoms, gastric emptying and ghrelin levels were evaluated at three different points during the study (pretreatment, after 4 weeks former treatment and after 4 weeks later treatment). The primary end point of this study was to determine whether nizatidine would improve clinical symptoms and gastric emptying in FD patients with or without impaired gastric emptying via affecting ghrelin levels. Results: Meal-related symptoms of the patients treated with nizatidine improved significantly (21/30; 70%) compared to those treated with placebo (3/30; 10%). In addition, nizatidine treatment also significantly improved gastroesophageal symptoms (16/30; 53%) compared to those treated with placebo (0/30; 0%). Nizatidine treatment in patients with FD accompanied by impaired gastric emptying significantly improved clinical symptoms and T_max value as a marker of gastric emptying (10/11, 91%; 9/11, 82%) compared to placebo therapy, respectively. There were no significant differences in ghrelin levels between nizatidine treatment and placebo therapy. Conclusion: Nizatidine administration significantly improved both gastric emptying and clinical symptoms in FD patients with impaired gastric emptying.

The dopaminergic system in patients with functional dyspepsia analysed by single photon emission computed tomography (SPECT) and an alpha-methyl-para-tyrosine (AMPT) challenge test

PurposeFunctional dyspepsia (FD) is a chronic condition characterized by upper abdominal symptoms without an identifiable cause. While the serotonergic system is thought to play a key role in the regulation of gut physiology, the role of the dopaminergic system, which is important in the regulation of visceral pain and stress, is under-studied. Therefore, this study investigated the dopaminergic system and its relationship with drinking capacity and symptoms in FD patients.MethodsIn FD patients and healthy volunteers (HV) the dopaminergic system was investigated by in-vivo assessment of central dopamine D2 receptors (D2Rs) with [123I]IBZM SPECT and by an acute, but reversible, dopamine depletion alpha-methyl-para-tyrosine (AMPT) challenge test. A nutrient drink test was performed to investigate the association between maximal ingested volume, evoked symptoms, and D2Rs.ResultsThe HV subjects comprised 12 women and 8 men (mean age 31 ± 3 years), and the FD patients comprised 5 women and 3 men (mean age 39 ± 5 years). The FD patients had a lower left plus right average striatal binding potential (BPNP) for the caudate nucleus (p = 0.02), but not for putamen (p = 0.15), which in the FD patients was correlated with maximal ingested volume (r = 0.756, p = 0.03). The D2R BPNP in the putamen was correlated with nausea (r = 0.857, p = 0.01). The acute dopamine depletion test, however, failed to reveal differences in prolactin release between the FD patients and the HV subjects.ConclusionThese preliminary data suggest that chronic rather than acute alterations in the dopaminergic system may be involved in the pathogenesis of FD. Further studies are required to reproduce our novel findings and to evaluate to what extent the dopaminergic changes may be secondary to abnormalities in serotonergic pathways.Electronic supplementary materialThe online version of this article (doi:10.1007/s00259-011-2015-6) contains supplementary material, which is available to authorized users.

Generation of dyspeptic symptoms by direct acid and water infusion into the stomachs of functional dyspepsia patients and healthy subjects

The mechanisms of the development of symptoms in functional dyspepsia (FD) patients have not been fully elucidated. We previously reported that acid directly infused into the stomach causes dyspeptic symptoms in asymptomatic healthy controls (HCs); however, the response to acid infusion of FD patients was not determined. To investigate the severity of dyspeptic symptoms induced by direct acid infusion in FD subjects and HCs. This was a multi-centre, cross-over, randomised, double-blind study in 23 FD subjects and 32 HCs. FD was defined using the Rome III criteria. All subjects were Helicobacter pylori negative. Each subject received two tests; 0.1 mol/L hydrochloric acid and water infused into the stomach. The presence and severity of 12 dyspeptic symptoms were assessed using a visual analogue scale. The proportion of subjects developing symptoms by acid or water infusion was significantly greater in FD subjects than HCs. All of the FD subjects experienced at least one symptom by water or acid infusion. In the FD subjects, the severity of symptoms was significantly greater with acid infusion than water infusion. The severity of symptoms in total and the scores for eight of the 12 symptoms induced by acid infusion was significantly greater in FD subjects than in HCs. The severity of dyspeptic symptom generation induced by direct acid infusion into the stomach was significantly greater in functional dyspepsia subjects than in healthy controls, suggesting that hypersensitivity to acid is one of the important mechanisms of the development of symptoms in functional dyspepsia patients.

Acotiamide (Z-338, YM443), a new drug for the treatment of functional dyspepsia

Introduction: Functional dyspepsia (FD) is a highly prevalent condition with a major impact on quality of life and high socio-economic and healthcare costs. To date, no treatment of established efficacy in FD is available. Acotiamide (Z-338 or YM443) is a new drug under development for the treatment of FD.Areas covered: Acotiamide is a gastroprokinetic drug that enhances acetylcholine release in the enteric nervous system via muscarinic receptor antagonism and acetycholinesterase inhibition. In conscious rats and dogs, acotiamide enhanced gastric contractility and accelerated delayed gastric emptying. Although in healthy volunteers acotiamide did not affect gastric emptying, gastric emptying and gastric accommodation were enhanced in FD. Acotiamide was evaluated in FD in several clinical studies in different countries and these are supportive of a symptomatic benefit. The beneficial effect is most consistently found with the 100 mg dose (three times a day) and primarily involves the postprandial distress syndrome symptoms of postprandial fullness, early satiety and upper abdominal bloating. The mechanism underlying the symptomatic benefit with acotiamide is not fully established but may involve enhanced gastric accommodation and increased gastric emptying.Expert opinion: Compared to placebo, no adverse events have been reported in the current short-term studies, while acotiamide seems efficacious for treating postprandial distress syndrome symptoms in FD patients.

The effect of omeprazole on gastric myoelectrical activity and emptying

Omeprazole, a proton pump inhibitor, is widely used for the treatment of patients with peptic ulcer, gastroesophageal reflux disease and functional dyspepsia (FD), although some studies have demonstrated that omeprazole delays gastric emptying. The purpose of this study was to investigate the efficacy of omeprazole on gastric motility including gastric myoelectrical activity and gastric emptying. This study was performed on 12 healthy volunteers. Gastric motility was evaluated with cutaneously recorded electrogastrography (EGG) and gastric emptying of semi-solid meals using the (13)C-acetic acid breath test. EGG and gastric emptying were measured before and after treatment with 20 mg omeprazole orally for 7 days. In the fasting state, the percentage of EGG normogastria increased significantly compared to the baseline. No significant changes were observed in other EGG parameters including the percentage of tachygastria and bradygastria in both fasting and postprandial states, and the power ratios between both before and after ingestion of omeprazole. In addition, administrated omeprazole did not show any significant differences in the gastric emptying parameters such as the half emptying time. We conclude that administration of omeprazole did not affect gastric motility but improved gastric myoelectrical activity. These effects of omeprazole may be one of the mechanisms involved in its efficacy in relieving dyspeptic symptoms in FD patients.

Effect of domperidone therapy on nocturnal dyspeptic symptoms of functional dyspepsia patients

To investigate the incidence of nocturnal dyspeptic symptoms in patients with functional dyspepsia (FD) and whether prokinetic drugs can alleviate them. Eighty-five consecutive Chinese patients with FD were included in this study. One week after single-blinded placebo run-in treatment, baseline nocturnal intragastric pH, bile reflux and nocturnal dyspeptic symptoms of eligible patients, including epigastric pain or discomfort, abdominal distention and belching, were investigated with questionnaires. Patients exhibiting nocturnal dyspeptic symptoms were randomly and double-blindly assigned to domperidone group or placebo group. Nocturnal intragastric pH and percentage of duodenogastric bile reflux time were determined after treatment. Of the 85 FD patients, 2 females without nocturnal symptoms, who responded to placebo run-in treatment, were excluded from the study, 30 (36.1%) exhibited nocturnal dyspeptic symptoms with increased duodenogastric bile reflux time (intragastric bilirubin absorbance > 0.14) and mean gastric pH (confirming the existence of bile reflux) (P = 0.021, 0.023) at night were included in the study. Of these 30 patients, 21 (70%) had overt nocturnal duodenogastric bile reflux, which was significantly higher than that of those without nocturnal symptoms (P = 0.026). The 30 patients were allocated to domperidone group or placebo group (n = 15). The nocturnal duodenogastric bile reflux and gastric pH were significantly decreased after domperidone treatment (P = 0.015, 0.021). The severity score of nocturnal dyspeptic symptoms was also significantly decreased after domperidone treatment (P = 0.010, 0.015, 0.026), which was positively correlated with the reduced nocturnal bile reflux or gastric pH (r = 0.736, 0.784, 0.753 or r = 0.679, 0.715, 0.697, P = 0.039, 0.036, 0.037 or P = 0.043, 0.039, 0.040). A subgroup of Chinese FD patients show overt nocturnal dyspeptic symptoms, which may be correlated with the excessive nocturnal duodenogastric bile reflux. Domperidone therapy can alleviate these symptoms.

Helicobacter pylori Testing in Patients with Funcional Dyspepsia: What Factors Dictate the Practice?

Purpose: Both functional dyspepsia (FD) and peptic ulcer disease (PUD) are associated with Helicobacter pylori (Hp) colonization. While Hp eradication is beneficial in patients with PUD, the same approach does not always reduce symptoms in FD patients. Despite this uncertainty, Rome III guidelines for FD recommend obtaining gastric biopsies for Hp testing in FD patients undergoing esophagogastroduodenoscopy (EGD). The extent to which this practice is performed is unknown. Methods: We evaluated the practice of obtaining gastric biopsies during EGD in dyspeptic patients with no endoscopic pathology (FD), compared this to patients with endoscopically confirmed PUD, and assessed the predictors of obtaining biopsies. All EGDs performed for evaluation of dyspepsia in adults at an urban hospital during the previous 29 months were identified and reviewed. Demographic and clinical information was extracted along with endoscopic and pathologic findings. Hp colonization was confirmed by histology. Results: A total of 1010 patients (618 women, mean age 50) underwent EGD. FD was diagnosed in 853 (84.5%) while 35 (3.5%) had PUD. The percentage of FD patients who had gastric biopsies taken did not differ significantly from patients with PUD (86.5% vs. 94.3%; p=0.37). Amongst those in which biopsies were obtained, the prevalence of Hp was 45.4% in FD compared to 60.6% in PUD patients (p=0.23). Within the FD cohort, there were significant ethnic differences in biopsy frequencies: Asians 91.7%, Hispanics 86.1%, African Americans 78.6%, and Caucasians 77.6%; p=0.016. FD patients born outside the U.S. were more likely to have biopsies taken than those born in the U.S. (87.2% vs. 65.7%; p=0.01). FD patients in whom gastropathy was noted endoscopically were more likely to have biopsies taken than those without gastropathy (95.7% vs. 63.4%; p<0.001). Neither patient age (p=0.08), gender (p=0.10), language (p=0.35), history of prior gastric surgery (p=0.34), history of prior Hp testing (p=0.39), nor the level of experience of the endoscopist (p=0.14) was predictive of whether or not biopsies would be obtained in the setting of FD. In multivariate logistic regression analysis controlling for age, gender, and ethnicity, both non-U.S. birth (OR 5.7 CI 1.7-18.8; p=0.005) and endoscopic gastropathy (OR 16.5 CI 8.4-32.5; p<0.001) remained significant predictors of obtaining biopsies. Conclusion: While the majority of patients with FD undergoing EGD had gastric biopsies taken, several factors were predictive of this practice including non-U.S. country of birth and the presence of endoscopic gastropathy. Further evaluation of the endoscopic assessment of FD patients may help provide important practice quality improvement measures.

Ecabet sodium induces neuronal nitric oxide synthase-derived nitric oxide synthesis and gastric adaptive relaxation in the human stomach

Gastric adaptive relaxation (GAR) is a major factor of functional dyspepsia (FD). Nitric oxide (NO) could be the key molecule responsible for GAR. We previously reported that the physiological gastric reservoir ability can be evaluated by measuring the cross-sectional area of the proximal stomach by abdominal ultrasonography (US). Ecabet sodium (ES), a gastro-protective antiulcer agent, has been shown to improve symptoms in FD patients. We examined the effects of ES on GAR in humans and on NO synthesis in vitro. GAR was measured by US in 14 subjects, 8 of whom had a pressure sensor inserted into their stomach, after treatment with ES, placebo, or no drugs. NO was measured in SH-SY 5Y cells using a fluorescent indicator. Neuronal, endothelial and inducible NO synthase (nNOS, eNOS and iNOS, respectively) expressions were examined in SH-SY 5Y cells by Western blotting. Compared to placebo, ES induced significantly greater dilatation of the proximal stomach after the subjects drank 300-400 ml water (P < 0.05). After ES intake, the intragastric pressure did not change significantly, but it tended to be lower (n = 8; P = 0.15). ES increased NO production and nNOS expression, but not iNOS or eNOS expression, in SH-SY 5Y cells in vitro. Pretreatment with non-selective NO synthase (NOS) inhibitor, but not with iNOS-selective inhibitor, reduced NO production by ES. ES may promote GAR in humans through nNOS-related NO; therefore, it may be useful for patients with FD.

Electroacupuncture Accelerates Solid Gastric Emptying and Improves Dyspeptic Symptoms in Patients with Functional Dyspepsia

The aims of this study were to investigate the effects of electroacupuncture (EA) at ST36 and PC6 points on solid gastric emptying and dyspeptic symptoms in patients with functional dyspepsia. Nineteen patients with functional dyspepsia (FD) were involved in the study, consisting of two parts: (1) acute effects of EA on solid gastric emptying in FD patients with delayed gastric emptying and (2) short-term (2-week) effects of EA on symptoms in FD patients with normal gastric emptying. Results were as follows. (1) Ten of the19 patients showed delayed gastric emptying of solids, and acute EA significantly improved delayed gastric emptying; the halftime for gastric emptying was reduced from 150.3+/-48.4 to 118.9+/-29.6 min (P=0.007). (2) In the nine patients with normal gastric emptying, 2-week EA significantly decreased the symptom score, from 8.2+/-3.3 at baseline to 1.6+/-1.1 (P < 0.001) at the end of treatment. We conclude that EA at the ST36 and PC6 points accelerates solid gastric emptying in FD patients with delayed gastric emptying and relieves dyspeptic symptoms in FD patients with normal gastric emptying.

A prospective 1‐year follow‐up study in patients with functional or organic dyspepsia: changes in gastrointestinal symptoms, mental distress and fear of serious illness

Psychosocial factors are common among patients with functional gastrointestinal disorders (FGIDs). Whether they affect the course of the disease remains unresolved. To evaluate whether reassuring investigations of primary care patients with functional dyspepsia (FD) and organic dyspepsia (OD) influence gastrointestinal (GI) symptoms and psychological factors, and to assess whether these changes are correlated. Four hundred consecutive patients with dyspepsia were referred for thorough examinations. Patients completed questionnaires screening symptoms at baseline and on 1-year follow-up. At baseline, there was no difference in GI symptoms, prevalence of mental distress or fear of serious illness between patients with FD or OD. On follow-up, the patients with FD had more GI symptoms, but there was no difference in mental distress or fear of serious illness. Relevant GI symptom reduction related to alleviation of mental distress (53.4% vs. 20.5%, P < 0.001) and fear of serious illness (56.5% vs. 23.7%, P = 0.002), but reached statistical significance only in patients with OD. Gastrointestinal symptoms in FD patients are long lasting compared with those with organic diseases. Reassuring investigations could lower mental distress and fear of serious illness in these patients. Psychological factor change correlates with the change in GI symptom severity and is not specific to FGIDs.

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.

New strategy of therapy for functional dyspepsia using famotidine, mosapride and amitriptyline

In functional gastrointestinal (GI) disorders including functional dyspepsia (FD) and irritable bowel syndrome (IBS), there might be no small extent of contributions of psychosomatic factors. As a therapy for IBS patients, the effectiveness of antidepressants has been reported. In this study, we evaluated the efficacy of H2-receptor antagonist (famotidine) and 5-HT4 receptor agonist (mosapride citrate). In addition, the effect of antidepressants was assessed as the second-step therapy. Patients complaining upper GI symptoms were diagnosed as FD excluding organic diseases. Randomized patients received 20 mg/day of famotidine or 15 mg/day of mosapride citrate for 4 weeks and the efficacy was compared between the two groups based on a 10-point visual analogue scale. When symptoms were not relieved (score improvement 0-2 points), patients received amitriptyline (30 mg/day) or no medication for 4 weeks randomly. Patients who had depression in psychological test (SDS) were omitted. As the first-step therapy, both famotidine and mosapride showed beneficial effects regardless of FD subtypes, age and gender. The efficacy of these two drugs in relieving FD symptoms was not significantly different. In patients who failed in the first-step therapy, amitriptyline showed beneficial effects. These findings might be clinically important in view of the efficient relief of symptoms in FD patients.

Absence of symptomatic benefit of lansoprazole, clarithromycin, and amoxicillin triple therapy in eradication of Helicobacter pylori positive, functional (nonulcer) dyspepsia

The aim of this study was to compare the effect of a combination of lansoprazole, clarithromycin, and amoxicillin (LCA) versus placebo on the severity of symptoms in functional dyspepsia patients who were positive for Helicobacter pylori (H. pylori). This was a double-blind, randomized, controlled clinical trial in adult patients with functional dyspepsia who were H. pylori positive. Patients were randomized to 7-day treatment with LCA or identical looking placebo. H. pylori status was confirmed by the urea breath test performed at baseline, at 6 wk, and at 6 and 12 months. The severity of eight upper GI symptoms was measured on a five-point Likert scale. The main outcomes were the change in average severity of the dyspepsia summary score of the eight symptoms and the proportion of patients who improved >/=4 points on the dyspepsia summary score. A total of 157 patients were included in the intention-to-treat analysis. LCA achieved cure of H. pylori infection in 82% of patients compared to 6% in the placebo group. The severity of dyspepsia symptoms improved over the 12-month study period, but for none of the outcome measures was there a significant difference between LCA and placebo. There was no difference in sustained improvement of dyspepsia symptoms when LCA was compared with placebo. An 82% cure rate of H. pylori infection was observed with LAC.

Absence of symptomatic benefit of lansoprazole, clarithromycin, and amoxicillin triple therapy in eradication of Helicobacter pylori positive, functional (nonulcer) dyspepsia

Objectives The aim of this study was to compare the effect of a combination of lansoprazole, clarithromycin, and amoxicillin (LCA) versus placebo on the severity of symptoms in functional dyspepsia patients who were positive for Helicobacter pylori ( H. pylori). Methods This was a double-blind, randomized, controlled clinical trial in adult patients with functional dyspepsia who were H. pylori positive. Patients were randomized to 7-day treatment with LCA or identical looking placebo. H. pylori status was confirmed by the urea breath test performed at baseline, at 6 wk, and at 6 and 12 months. The severity of eight upper GI symptoms was measured on a five-point Likert scale. The main outcomes were the change in average severity of the dyspepsia summary score of the eight symptoms and the proportion of patients who improved ≥4 points on the dyspepsia summary score. Results A total of 157 patients were included in the intention-to-treat analysis. LCA achieved cure of H. pylori infection in 82% of patients compared to 6% in the placebo group. The severity of dyspepsia symptoms improved over the 12-month study period, but for none of the outcome measures was there a significant difference between LCA and placebo. Conclusions There was no difference in sustained improvement of dyspepsia symptoms when LCA was compared with placebo. An 82% cure rate of H. pylori infection was observed with LAC.

Clinical study on therapeutic effect of shuwei decoction"Equation missing" on functional dyspepsia

To explore the clinical effectiveness and therapeutic mechanism of Shuwei Decoction in treating functional dyspepsia (FD). A total of 124 FD patients were randomly divided into two groups: Shuwei Decoction group (60 cases) and the control group (64 cases) treated with cisapride. After one month treatment, all patients were examined with motilin and electrogastrography (EGG). The therapeutic effectiveness of Shuwei Decoction group was much better than that of the control group (P<0. 05), while the changes on motilin and EGG in the two groups were relatively similar (P<0.05). Shuwei Decoction could effectively raise motilin level, promote gastric movement and improve the clinical symptoms in FD patients.

Impact of Sex and Psychological Factors on the Water Loading Test in Functional Dyspepsia

The pathogenesis of upper abdominal symptoms in patients with functional dyspepsia (FD) is still unclear. The water loading test (WLT) is a new method for evaluation of gastric function. Our aim was to determine the impact of sex, age and psychological factors on the results of WLT in FD patients, FD-subgroups and healthy controls (HCs), and to evaluate the safety of the test. Fifty-six HCs and 35 consecutive patients with FD drank mineral water (100 ml/min) until intolerable. Serum samples for sodium, potassium and creatinine was taken before and after drinking. Water quantity was registered and symptoms were assessed after maximal water intake and 30 min later using a VAS scale. Participants also completed questionnaires measuring psychological general well-being (PGWB) and gastrointestinal symptoms (GSRS and Mearin score). Healthy men drank more than healthy women, 2350 +/- 105 ml versus 1860 +/- 100 ml (P < 0.01), and the same gender difference was noted in FD patients, 1770 +/- 115 ml versus 1180 +/- 110 ml (P < 0.01). Maximal water intake was significantly higher in HC than in FD patients, both in males (P < 0.001) and females (P < 0.0001). Age had no impact on drinking capacity. FD patients had more symptoms 30 min after maximal water intake than HCs. Serum sodium decreased from 141 +/- 0.3 mmol/l to 138 +/- 0.5 mmol/l. Two of the assessed psychological factors, general health and depressed mood, correlated with water intake in FD patients (Rho = 0.47, P < 0.01 respectively Rho = 0.41, P < 0.05). WLT is a useful, simple and safe test for evaluating symptoms in FD patients. Sex, but not age affects the results of the WLT. Furthermore, psychological factors must also be taken into consideration when interpreting the WLT.

Eradication of Helicobacter pylori prevents ulcer development in patients with ulcer‐like functional dyspepsia

Although the eradication of Helicobacter pylori infection benefits patients with gastric or duodenal ulcers, the value of eradicating the infection in the patients with functional dyspepsia (FD) remains controversial. To determine whether eradicating H. pylori can prevent the subsequent development of ulcers or relieve the symptoms of functional dyspepsia patients. In a double-blind, placebo-controlled trial, 161 patients infected with H. pylori who had functional dyspepsia were randomly assigned to 7 days of treatment with a lansoprazole-based triple therapy or placebo and then followed for 1 year. The main outcome measures were the development of peptic ulcers and the resolution of symptoms. H. pylori was eradicated in 63 out of 81 patients (78%) in the treatment group and none of the 80 patients (0%) in the placebo group. During the follow-up period, two patients in the treatment group and six patients in the placebo group developed peptic ulcers at repeat endoscopy (2.5% vs. 7.5%; 95% CI: -12 to 2). The reduction in ulcer rates was statistically significant in the 'ulcer-like' sub-group (0% vs. 16.7%; 95% CI: -32 to -2), but not in the 'dysmotility-like' and 'unclassifiable' sub-groups. Regarding symptom response, the resolution rates of symptoms were similar between the treatment and placebo groups (58.0% vs. 55.0%, 95% CI: -12 to 18). Additionally, no significant differences existed in the symptom responses between the treatment and control arms in each of the dyspepsia sub-groups. Eradicating H. pylori can prevent the subsequent development of peptic ulcers in the patients with 'ulcer-like' functional dyspepsia. However, this approach does not significantly reduce the symptoms of functional dyspepsia patients.