Impact of Different Helicobacter pylori Eradication Therapies on Gastrointestinal Symptoms.
ABSTRACT: Background and Objectives: Helicobacter pylori (H. pylori) infection impairs quality of life. However, whether eradication therapy ameliorates gastrointestinal symptoms remains questionable. The main objective of this study was to evaluate the influence of H. pylori eradication therapy on gastrointestinal symptoms. Materials and Methods: A total of 140 patients, 59 women and 81 men, with a mean age of 61 and suffering from H. pylori infection in the University Hospital of Split, Croatia, were enrolled in the study. Patients were randomly assigned to either concomitant or hybrid therapies. The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire was completed by patients prior to and after the eradication therapy. Results: In both groups, the total GSRS score improved significantly after therapy. In the concomitant group, the abdominal pain score, reflux symptoms score and indigestion score decreased significantly after therapy. In the group with hybrid therapy, all five groups of symptoms (abdominal pain, reflux symptoms, indigestion, diarrhea and constipation) significantly decreased after therapy. Patients with adverse events had significantly higher total GSRS scores after eradication therapy. Conclusions: H. pylori eradication therapy could alleviate gastrointestinal symptoms regardless of the treatment used, but the favorable effect seemed to be more pronounced after hybrid therapy.
Project description:BACKGROUND:Little is known about how the menstrual cycle affects gastrointestinal function and self-reported stress in young, healthy women taking oral contraceptives (OC). This study prospectively characterized gastrointestinal function and symptoms on each day throughout the menstrual cycle. METHODS:Healthy women aged 18-35?years (n?=?78) who took OC participated in the 5-week observational study. Stool frequency, self-reported stress, stool form measured by the Bristol Stool Form Scale (BSFS), and gastrointestinal symptoms measured by a modified version of the Gastrointestinal Symptom Rating Scale (GSRS) were assessed daily. GSRS scores were reported (1?=?no discomfort at all, 7?=?very severe discomfort) and were averaged for individual syndrome scores or summed for the total score. The validated, weekly version of the GSRS was completed at two time points to reflect menstruation and 1?week prior to menstruation (n?=?72). Outcomes were analyzed in linear mixed models with the Dunnett's post hoc test against day 1 of menstrual bleeding or with nonparametric tests. RESULTS:Daily stress (P?=?0.0018), BSFS score (P?=?0.0493), stool frequency (P?=?0.0241), abdominal pain (P?<?0.0001), diarrhea (P?=?0.0022), constipation (P?=?0.0446), reflux (P?=?0.0193), and indigestion (P?<?0.0001) all varied significantly by the day of the menstrual cycle. Dunnett's post hoc tests showed that scores (mean?±?SEM) on the first day of bleeding (day 1) for daily abdominal pain (2.6?±?0.2), diarrhea (1.7?±?0.1), and indigestion (2.1?±?0.2) symptoms were higher than scores on all other days of the menstrual cycle (P?<?0.05) with scores not on day 1 falling under 1.5, or between no discomfort at all and slight discomfort. Reflux, stool frequency, BSFS, self-reported stress, and constipation were higher on day 1 (P?<?0.05) than on 12, 8, 6, 4, and 2 other days of the menstrual cycle, respectively. The median (IQR) GSRS score was higher during the week of menstruation than the week prior to menstruation for diarrhea [1.50 (1.00-2.33) vs 1.33 (1.00-2.00), P?=?0.002] and abdominal pain [2.00 (1.33-2.67) vs 1.67 (1.33-2.33), P?=?0.011] syndrome scores. CONCLUSION:Bowel habits appear to vary across the menstrual cycle and suggest more gastrointestinal discomfort on day 1 of menstrual bleeding in healthy women taking OC. Future interventional studies could identify ways to improve gastrointestinal symptoms in healthy women during menstruation.
Project description:INTRODUCTION:The eradication rate of Helicobacter pylori following the standard triple therapy is declining. This study was conducted to test whether the addition of Lactobacillus reuteri to the standard triple therapy improves the eradication rates as well as the clinical and pathological aspects in H. pylori infection. METHODS:A total of 70 treatment-naïve patients were randomly assigned into group A (the L. reuteri treated group) and group B (the placebo control group). Patients were treated by the standard triple therapy for 2 weeks and either L. reuteri or placebo for 4 weeks. They were examined by symptom questionnaire, H. pylori antigen in stool, upper endoscopy with biopsies for rapid urease test and histopathological examination before treatment and 4 weeks after treatment. RESULTS:The eradication rate of H. pylori infection was 74.3% and 65.7% for both L. reuteri and placebo treated groups, respectively. There was a significant difference regarding the reported side effects, where patients treated with L. reuteri reported less diarrhea and taste disorders than placebo group. A significant difference within each group was observed after treatment regarding Gastrointestinal Symptom Rating Scale (GSRS) scores; patients treated with L. reuteri showed more improvement of gastrointestinal symptoms than the placebo treated group. The severity and activity of H. pylori associated gastritis were reduced after 4 weeks of therapy in both groups. The L. reuteri treated group showed significant improvement compared with the placebo treated group. CONCLUSION:Triple therapy of H. pylori supplemented with L. reuteri increased eradication rate by 8.6%, improved the GSRS score, reduced the reported side effects and improved the histological features of H. pylori infection when compared with placebo-supplemented triple therapy.
Project description:Partial response to proton pump inhibitor (PPI) therapy poses a healthcare challenge. This study aimed to compare symptom profiles in partial PPI responders and treatment-naïve patients with gastroesophageal reflux disease (GERD).A post hoc analysis of data from two studies was performed. Partial PPI responders with GERD (n = 580; NCT00703534) had frequent (? 3 days/week) heartburn and/or regurgitation despite PPI therapy; patients with no improvement were excluded. Treatment-naïve patients with GERD (diagnosed by endoscopy and pH-metry; n = 203; NCT00291746) had frequent (? 3 days/week) upper gastrointestinal symptoms. The Gastrointestinal Symptom Rating Scale (GSRS) was completed by all patients at study entry and by treatment-naïve patients after PPI therapy.The highest (mean [95% confidence interval]) discomfort scores were reported in the Reflux (heartburn, regurgitation), Indigestion, and Abdominal pain domains of the GSRS, both in partial PPI responders (4.3 [4.2-4.4], 3.7 [3.6-3.8], and 3.4 [3.3-3.5], respectively) and in treatment-naïve patients (3.5 [3.3-3.7], 3.6 [3.4-3.7], and 3.1 [3.0-3.3], respectively). Partial PPI responders reported more discomfort than treatment-naïve patients in the Reflux, Abdominal pain, and Constipation domains (4.3 [4.2-4.4] vs. 3.5 [3.3-3.7], 3.4 [3.3-3.5] vs. 3.1 [3.0-3.3], and 2.5 [2.4-2.6] vs. 2.1 [1.9-2.2], respectively). All GSRS domain scores improved in treatment-naïve patients following PPI therapy.Symptom patterns in partial PPI responders were similar to those in treatment-naïve patients with GERD, but partial PPI responders experienced more severe reflux, abdominal pain, and constipation than did treatment-naïve patients.
Project description:Background:Helicobacter pylori is the major cause of chronic gastritis, and considered as a risk factor for peptic ulcer and gastric cancer. The H. pylori standard antibiotic therapy fails in about 25-30% of cases, particularly because of the increasing occurrence of resistance to antibiotics. The aim of the current study was to investigate whether the strain Lactobacillus reuteri DSM17648 which has been previously shown to reduce Helicobacter pylori load additionally improves gastrointestinal symptoms in H. pylori positive subjects when used in a 28?days supplementation. Methods:In a single-blinded, placebo controlled study 24 H. pylori-positive adults (13 females, 11 males; median age: 43.5) with mild dyspepsia (mean GSRS score: 11.82) received placebo for 28?days followed by Pylopass™ containing the L. reuteri DSM 17648 (2?×?1010 cells per day) for the following 28?days. After 28?days of Pylopass™ supplementation the change in H. pylori load was measured by 13C urea breath test (13C-UBT) and the change in symptoms were determined by the Gastrointestinal Symptom Rating Scale (GSRS). In addition, blood assessments were conducted to measure the physiological changes relevant in terms of safety. Results:After a 28-day supplementation phase with Pylopass™ there was a trend for reduction of H. pylori load in 62.5% of the subjects and for the overall GSRS scores in 66.7% of subjects. The overall GSRS scores from baseline to day 56 following all 24 subjects undergoing the placebo phase followed by the Pylopass™ phase was significantly decreased (p =?0.005). The mean 13C-UBT ? value decreased by 22.5% during the Pylopass™ supplementation phase (-?3.14), while the mean 13C-UBT ? increased by 37.3% (+?3.79) in the placebo phase. No side effects were reported in either study phase. Conclusion:The results demonstrated that L. reuteri DSM17648 has the potential to suppress H. pylori infection, and may lead to an improvement of H. pylori-associated gastro intestinal symptoms. Further studies with adequate power should be performed. Trial registration:Clinicaltrials.gov: NCT02051348 (January 30, 2014).
Project description:<h4>Background</h4>Laparoscopic Roux-en-Y gastric bypass (LRYGB) is an effective treatment for morbid obesity, but might aggravate gastrointestinal complaints and food intolerance. The long-term prevalence of these symptoms has not been well studied.<h4>Methods</h4>In a cross-sectional study, all patients who underwent primary LRYGB from May to October 2012 were approached 2 years after surgery to complete a general health questionnaire, the Gastrointestinal Symptom Rating Scale (GSRS), and a food intolerance questionnaire. The results were compared with those for a control group of morbidly obese patients.<h4>Results</h4>A total of 249 patients were included for analysis, representing a response rate of 93·9 per cent. Mean(s.d.) total weight loss was 30·8(8·7) per cent. The total mean GSRS score was higher in patients who had LRYGB (median 2·19 versus 1·75 in unoperated patients; P?<?0·001); the difference in symptoms of indigestion was most notable (P?<?0·001). Food intolerance for specific products was reported by 70·7 (95 per cent c.i. 64·8 to 76·0) per cent of the postoperative patients, for a median of 4 foods. There was a positive correlation between food intolerance and score on the GSRS. There was no correlation between either food intolerance or the total mean GSRS score and weight loss, but there was a correlation between weight loss and abdominal pain.<h4>Conclusion</h4>At 2 years after surgery, patients undergoing LRYGB for morbid obesity have more gastrointestinal complaints than obese controls. Food intolerance is a common side-effect of LRYGB independent of degree of weight loss or the presence of other abdominal symptoms.
Project description:This study aimed to resolve controversy regarding the effects of Helicobacter pylori eradication therapy and H. pylori infection in gastro-oesophageal reflux disease.A randomized, double-blind, multicentre trial was performed in patients presenting with reflux symptoms. H. pylori-positive patients were randomized to receive either antibiotics or placebo for 7 days. H. pylori-negative patient controls received placebo. All received esomeprazole 20?mg b.d. for 7 days, followed by 40?mg o.d. to complete an 8-week course, and were followed up for 32 weeks by telephone.In this study, 198/589 (34%) patients were H. pylori-positive and 113 H. pylori-negative patients served as controls. Baseline endoscopy revealed 63% Los Angeles grade 0A and 37% Los Angeles grade BCD oesophagitis with no difference between patient groups. Symptom improvement on esomeprazole was seen in 89%. H. pylori eradication was successful in 82%. H. pylori eradication had no effect on symptomatic relapse (hazard ratio 1.15, 95% CI 0.74-1.8; p?=?0.5). Overall, H. pylori-positive patients had a lower probability of relapse compared to H. pylori-negative controls (hazard ratio 0.6, 95% CI 0.43-0.85; p?=?0.004). Relapse hazard was modulated also by oesophagitis grade (BCD vs. 0A, hazard ratio 2.1, 95% CI 1.5-3.0).Relapse of gastro-oesophageal reflux disease symptoms after a course of high dose acid suppression took longer for H. pylori-positive patients than H. pylori-negative controls; however eradication therapy had no effect on the risk of relapse; ClincialTrials.gov number, NCT00574925.
Project description:Background:Despite increased emphasis on patient-reported outcomes, few studies have focused on abdominal pain symptoms before and after Roux-en-Y gastric bypass (RYGB). The aim of this study was to quantify chronic abdominal pain (CAP) in relation to RYGB. Methods:Patients with morbid obesity planned for RYGB were invited to participate at a tertiary referral centre from February 2014 to June 2015. Participants completed a series of seven questionnaires before and 2?years after RYGB. CAP was defined as patient-reported presence of long-term or recurrent abdominal pain lasting for more than 3?months. Results:A total of 236 patients were included, of whom 209 (88·6 per cent) attended follow-up. CAP was reported by 28 patients (11·9 per cent) at baseline and 60 (28·7 per cent) at follow-up (P?<?0·001). Gastrointestinal Symptom Rating Scale (GSRS) scores (except reflux scores) and symptoms of anxiety increased from baseline to follow-up. Most quality of life (QoL) scores (except role emotional, mental health and mental component scores) also increased. At follow-up, patients with CAP had higher GSRS scores than those without CAP, with large effect sizes for abdominal pain and indigestion syndrome scores. Patients with CAP had more symptoms of anxiety, higher levels of catastrophizing and lower QoL scores. Baseline CAP seemed to predict CAP at follow-up. Conclusion:The prevalence of CAP is higher 2?years after RYGB compared with baseline values.
Project description:BACKGROUND AND AIMS:Patients that have failed therapy for Helicobacter pylori (H. pylori) infection are incompletely characterized. The aim of this study was to characterize a H. pylori treatment resistant cohort compared to the cohorts of newly diagnosed, earlier eradicated and non-infected. MATERIAL AND METHODS:Patients were selected from routine referrals to the Endoscopy units at three different Norwegian hospitals. In all four cohorts, gastric biopsies were scored according to the Sydney classification, and symptoms according to the Gastrointestinal Symptom Rating Scale score, including sub-scores for upper gastrointestinal symptoms and functional bowel symptoms. Patients in the H. pylori resistant group were treated with a triple therapy regimen that consisted of levofloxacin, amoxicillin and a proton pump inhibitor. RESULTS:We included 185 patients, 42 H. pylori treatment resistant, 50 newly diagnosed, 61 previously H. pylori eradicated and 32 never infected. The treatment-resistant cohort had higher scores for upper gastrointestinal symptoms and functional bowel symptoms compared to the other groups except for the group being never H. pylori infected. The H. pylori resistant patients had lower Sydney scores than patients with newly diagnosed H. pylori infection. The triple combination showed a high efficacy of 91% to eradicate H. pylori. CONCLUSIONS:Patients with treatment-resistant H. pylori infection had more gastrointestinal symptoms, but a lower Sydney score than patients with newly diagnosed infection. A treatment regimen including levofloxacin showed a high efficacy in eradicating H. pylori in patients that previously had failed eradication treatment.
Project description:BACKGROUND: Helicobacter pylori eradication therapy is routinely used for treating patients with peptic ulcer disease. AIMS: To assess the value of symptomatic response to H pylori eradication therapy as a marker of post-treatment H pylori status. PATIENTS AND METHODS: One hundred and nine dyspeptic patients with active duodenal or gastric ulceration association with H pylori infection had their symptoms measured by a validated questionnaire before and three months following H pylori eradication therapy. The symptomatic response was compared with post-treatment H pylori status as determined by the 14C urea breath test. RESULTS: An eradication rate of 84% was achieved. Of the 92 patients eradicated of H pylori, 47% experienced complete or near complete resolution of dyspepsia. Of the 17 patients in whom the infection was not eradicated, only one (6%) experienced resolution of dyspepsia. Resolution of dyspepsia was therefore a powerful predictor of eradication of H pylori with a predictive value of 98%. In contrast, persistence of dyspepsia was a weak predictor of persisting infection with a predictive value of only 25%. Excluding patients with endoscopic evidence of coexisting oesophagitis and/or retrosternal discomfort or reflux at initial presentation did not increase the predictive value of persisting dyspepsia for persisting infection. CONCLUSIONS: Complete resolution of dyspeptic symptoms is a powerful predictor of eradication of H pylori infection in ulcer patients. Persistence of symptoms is a weak predictor of persisting infection and patients with persisting dyspepsia must have their H pylori status rechecked to guide future management.
Project description:BACKGROUND:The purpose of this study was to assess changes in gastrointestinal symptom severity in patients with autoimmune disease who were switched from mycophenolate mofetil to enteric-coated mycophenolate sodium (EC-MPS). METHODS:In this national, explorative, single-arm study, 111 patients were enrolled and switched to equimolar EC-MPS at baseline. The primary endpoint was change in the Gastrointestinal Symptom Rating Scale (GSRS) total score after 6-8 weeks of treatment (Visit 2). The optional follow-up visit was 6-12 weeks after completion of the study (Visit 2). Secondary endpoints were changes in GSRS subscale score; changes in gastrointestinal-related quality of life measured by the Gastrointestinal Quality of Life Index (GIQLI); and general health-related quality of life (HRQoL) measured by Psychological General Well-Being Index and assessment of overall treatment effect (OTE). Change was evaluated by paired t-tests. RESULTS:At Visit 2, the mean ± standard deviation GSRS total score improved from 2.28±1.13 to 2.02±0.93 points. The change (-0.28±0.92 points, P=0.002) was statistically significant. The change at the follow-up visit (-0.36±0.94 points, P=0.001) was statistically significant and more than the minimal clinical important difference. GSRS subscores showed statistically significant and clinically relevant improvement for abdominal pain (-0.51±1.2 points, P<0.001) and indigestion (-0.42±1.33 points, P=0.002). Overall GIQLI score showed significant improvement from baseline to Visit 2 (-5.8±18.6 points, P=0.002). Per OTE, improvement was reported in 44.1% and 34.2% patients as rated by physicians and patients, respectively. The majority of patients (55%) reported OTE-HRQoL as unchanged. Diarrhea and nausea were the commonly reported adverse events. CONCLUSION:Patients switched to EC-MPS experienced less gastrointestinal symptom burden and showed improvement in HRQoL.