FSSG Scores Research Articles

Beneficial Effect of Heat-Killed Lactic Acid Bacterium Lactobacillus johnsonii No. 1088 on Temporal Gastroesophageal Reflux-Related Symptoms in Healthy Volunteers: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study.

A randomized, placebo-controlled, double-blind, parallel-group clinical study was conducted to examine the effects of ingesting a heat-killed lactic acid bacterium, Lactobacillus johnsonii No. 1088 (LJ88) on temporal gastroesophageal reflux-related symptoms in healthy volunteers. A total of 120 healthy Japanese volunteers of both sexes, aged between 21 and 63 years, whose Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) total score was 8 or greater, but who were not diagnosed with functional dyspepsia according to the Rome IV classification, were enrolled. They were randomly assigned to either the LJ88 or placebo group and instructed to ingest the test food (1 billion heat-killed LJ88 or placebo) once a day for six weeks. Gastroesophageal reflux-related symptoms were evaluated using FSSG scores as a primary endpoint. The Gastrointestinal Symptoms Rating Scale (GSRS), stomach state questionnaire, and serum gastrin concentration were used as secondary endpoints. In the FSSG evaluation, the heartburn score was significantly improved at 6 weeks in the LJ88 group compared to the placebo group. No severe adverse events related to the test food were observed. In conclusion, daily ingestion of heat-killed LJ88 improved temporal heartburn symptoms in non-diseased individuals.

Endoscopic anti-reflux mucosectomy (ARMS) and endoscopic anti-reflux ablation (ARMA) as a potential treatment for gastroesophageal reflux - preliminary report.

<b><br>Introduction:</b> Gastroesophageal reflux (GERD) is one of the most common disorders of the alimentary tract. Apart from troublesome symptoms, untreated GERD can lead to Barrett's esophagus and, as a consequence, esophageal adenocarcinoma. As for now, the most common treatment of GERD is PPI pharmacotherapy. However, in a number of cases, this treatment is not sufficient or the patient does not tolerate PPI-group drugs. In such cases, interventional therapy is recommended. So far, laparoscopic fundoplication has been the only suggested option. Other, minimally invasive procedures such as Stretta, MUSE, TIFF, or EsophyX were not recommended due to the lack of clinical data. In 2014, Professor H.Inoue from the Digestive Diseases Center, Showa University in Japan reported on the first series of novel, endoscopic, anti-reflux procedures: anti-reflux mucosectomy (ARMS) and anti-reflux mucosal ablation (ARMA).</br> <b><br>Methods:</b> We conducted our prospective, single-center study in 30 patients (14 female, 16 male) with PPI-refractory GERD. All patients underwent FSSG and GERD-HRQL evaluation and GE junction pressure study prior, 6 weeks and 6 months after the procedures. After the procedure, all patients received PPI treatment for 4 weeks.</br> <b><br>Results:</b> We successfully completed the procedures in all 30 patients. The mean procedure time was 42 minutes. No complications occurred. In 86.67% (26) of our patients, we achieved total remission of GERD symptoms, FSSG scores < 6 and GERD-HRQL scores < 8.</br> <b><br>Conclusions:</b> The results of our study show that ARMS and ARMA are simple, safe, improve GERD-related symptoms, and restore the GE junction's anti-reflux capacity.</br&gt.

Efficacy of vonoprazan 10mg compared with 20mg for the initial treatment in patients with erosive esophagitis: a randomized pilot study.

The study aimed to investigate the efficacy of vonoprazan 10mg compared with 20mg in patients with erosive esophagitis. Seventy-three patients with erosive esophagitis were randomly divided into two groups either vonoprazan 20mg (n = 37) or 10mg (n = 36). They were administered each dose for 4weeks as the initial treatment followed by maintenance treatment with 10mg for 8weeks. The primary endpoints were mucosal healing rate and symptom relief at 4weeks. The secondary endpoint was symptom relief at 12weeks after the maintenance treatment. Mucosal healing was assessed endoscopically, and symptom relief was assessed using the FSSG score. At 4weeks, the endoscopic healing rates of the 20mg and 10mg groups were 94.6% and 94.4%, respectively. The FSSG scores of the 20mg and 10mg groups were significantly decreased in both treatment groups from 13 (4-39) to 4 (0-25) and 14 (4-40) to 3 (0-29), respectively. At 12weeks, the scores further decreased to 2 (0-13) and 2 (0-26), respectively. The vonoprazan 10mg group showed a similar therapeutic effect to the 20mg group in mucosal healing at 4weeks and in symptom relief throughout the study period. When stratified by esophagitis grading, these findings were still demonstrated in grade A/B patients but not in grade C/D patients. Our findings suggest that initial treatment with vonoprazan 10mg might be useful especially in patients with mild erosive esophagitis. Large controlled studies are warranted to confirm our investigation.

Effects of Pistacia lentiscus and Coriander Triphala on Adult Gastroesophageal Reflux Disease: A Randomized Double-Blinded Clinical Trial

Background: The cardinal symptoms of gastroesophageal reflux disease include heartburn (pyrosis) and regurgitation. Conventional treatment is done by proton pump inhibitors. In Persian traditional medicine, several herbs (single or combined) have been used to treat gastrointestinal disorders. Objectives: This study aimed to assess the effects of Pistacia lentiscus (mastic) and Coriander Triphala on reflux symptoms compared to omeprazole in a double-blinded randomized clinical trial. Methods: In a double-blinded, multicenter, randomized clinical trial, we assessed the effects of Pistacia lentiscus L., Coriander Triphala, and omeprazole on the symptoms of GERD in Tabriz, Iran, in 2018 - 2019. Thus, 105 patients with GERD symptoms were assigned randomly to three groups as group A (Pistacia lentiscus L., 1000 mg/TDS), group B (Coriander Triphala, 1000 mg/TDS), and group C (omeprazole, 20 mg/day plus five placebo capsules per day). The assessments were done at the beginning and the end of the study using FSSG, VAS, RS, and GERD-HRQL questionnaires. Results: In the beginning, no significant differences were observed between the groups in the background characteristics. There was no statistically significant difference between Pistacia lentiscus, Coriander Triphala, and omeprazole in the improvement of FSSG, VAS, GERD-HRQL, and reflux scores. In all groups, the FFSG, VAS, reflux, and GERD-HRQL scores significantly decreased and improved after four weeks of intervention compared to the respective baselines. The FSSG score improvements after four weeks of intervention were 73.68%, 83.33%, and 68.62%, in groups A, B, and C, respectively. The VAS score improvements were 66.66%, 75.00%, and 62.50% in groups A, B, and C, respectively. Improvements in GERD-HRQL were 90.00%, 91.28%, and 82.00%, in groups A, B, and C, respectively. Reflux improvements were 66.66%, 80.00%, and 66.66% in groups A, B, and C, respectively. Conclusions: The results showed that Pistacia lentiscus and Coriander Triphala are as effective as omeprazole in the treatment of GERD.

Clinical Relevance of Blood Glucose and Gastroesophageal Reflux Symptoms to Depressive Status in Patients with Type 2 Diabetes Mellitus.

A relationship between diabetes and depression is apparent. To clarify the clinical relevance of diabetic patients' gastroesophageal symptoms to their psychological status, we retrospectively analyzed the data from a Selfrating Depression Scale (SDS) and a Frequency Scale for Symptoms of Gastroesophageal reflux disease (FSSG) among 143 type 2 diabetic patients who visited a general medicine department. Among the 45 Japanese patients enrolled, the group with relatively high SDS scores (≥ 36) showed higher (FSSG) dysmotility symptom scores versus the low-SDS (< 36) group, although the 2 groups' characteristics and laboratory data were not significantly different. Positive correlations of postprandial plasma glucose (PPG) levels with FSSG scores (R=0.321, p<0.05), particularly with reflux scores (R=0.455, p<0.01) were revealed. PPG and HbA1c levels were not correlated with SDS scores. The patients' SDS scores were significantly correlated with their FSSG scores (R=0.41, p<0.01), suggesting that depressive status is linked to GERD-related manifestations. Considering that the patients' PPG levels were correlated with GERD-related symptoms, diabetic patients' blood glucose levels are associated with depressive status. Collectively, key symptoms related to GERD and glucose level values would be helpful.

Correlations between Depressive Condition and Gastroesophageal Reflux Symptoms in Patients Visiting a Department of General Medicine.

To clarify the potential relevance of patients' chief complaints at a general medicine department to their self-rating depression scale (SDS) and frequency scale for symptoms of gastroesophageal reflux disease (GERD) (FSSG) scores, we analyzed data of 478 patients who visited our general medicine department. The chief complaints (553 symptoms of 447 patients) were categorized into major symptom-based groups: respiratory (31%), circulatory (3%), gastrointestinal (GI) tract (26%), neurology (8%), orthopedic and skin (10%), and systemic (22%) symptoms. The SDS score tended to be higher in females and younger patients. The FSSG score did not differ by gender but was higher in younger patients. The patients receiving social welfare had higher SDS and FSSG scores. A close inter-relationship between the FSSG (including both degrees of reflux and dysmotility) and SDS was observed in all patients. Although the averages of the SDS and FSSG scores were not significantly different among the symptom-based categories, we observed significantly positive correlations between the FSSG and SDS in each category, suggesting that depressive status may be closely related to GERD-related symptoms regardless of the patients' chief complaints. An initial checkup of patients' psychological condition and/or GERD-like symptoms could help screen for latent disorders in outpatients with uncertain complaints.

Reduction in Gastroesophageal Reflux Disease Symptoms Is Associated with Miso Soup Intake in a Population-Based Cross-Sectional Study: The Nagahama Study.

Dietary habits and lifestyles are considered to affect the frequency of epigastric symptoms. In our previous study, we found that three amino acids in Japanese broth promoted gastric emptying. We hypothesized that a higher consumption of miso soup which was mainly composed of Japanese broth and miso paste would be associated with a lower frequency of epigastric symptoms. We conducted a cross-sectional study of the association between frequency of miso soup intake and reflux or dyspepsia symptoms in a general Japanese population. Sixteen items of dietary habits were assessed using a self-reported questionnaire, and epigastric symptoms were evaluated using the Frequency Scale for Symptoms of Gastroesophageal Reflux Disease (FSSG). We fitted generalized linear models to analyze the association between miso soup intake and FSSG, reflux, or dyspepsia scores adjusted by age, sex, body mass index (BMI), another 15 dietary habits, smoking, drinking alcohol, and unfavorable dietary behaviors. A total of 9,364 subjects were included in the analysis. Trend analysis revealed that higher frequency of miso soup intake was associated with lower FSSG scores (p<0.001). In a generalized linear model, daily intake of miso soup was associated with lower FSSG, reflux, and dyspepsia scores independent of age, sex, BMI, other 15 dietary habits, smoking, drinking alcohol, and unfavorable dietary behaviors (estimate=-0.46, -0.22, and -0.27, respectively; 95% CI=-0.83, -0.12; -0.38, -0.07; and -0.47, and -0.08, respectively). Dairy intake of miso soup was associated with lower epigastric symptoms.

Helicobacter pylori Eradication Therapy Ameliorates Latent Digestive Symptoms in Chronic Atrophic Gastritis

Background/Aims: This study investigated the effect of Helicobacter pylori eradication therapy on latent digestive symptoms in chronic atrophic gastritis. Methods: We enrolled 650 health checkup patients who underwent eradication therapy for chronic gastritis and completed a self-report questionnaire before and after the treatment between January 2014 and December 2016 at the Japanese Red Cross Society Kyoto Daiichi Hospital. Results: H. pylori eradication therapy for chronic atrophic gastritis improved latent digestive symptoms, including both the acid reflux and dyspepsia components in the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) scores. The effect was sustained until 1 year after the treatment. Higher FSSG scores (≥8 points) before H. pylori eradication therapy and age <70 years were significantly associated with the improvement of digestive symptoms after H. pylori eradication therapy. Conclusion: H. pylori eradication therapy may improve patients’ quality of life through the resolution of latent abdominal symptoms.

Effects of “Satureja hortensis L.” on Improving Adult Gastroesophageal Reflux Disease: A Double-Blinded, Randomized, Controlled Clinical Trial

Background: Gastro-esophageal reflux disease (GERD) is one of the most widespread gastrointestinal disorders. In addition, there is increasing evidence that not all patients respond to its current remedies. Objectives: The aim of this pilot study was to investigate the effect of �Satureja hortensis L.� on improving the symptoms of mild to moderate GERD in adults. Methods: In this double-blind, randomized, controlled, clinical trial, we evaluated the efficacy of �Satureja hortensis L.� compared to placebo in the symptoms of GERD in fifty-eight adultswith GERD who referred to Hazrat Rasool-e-Akram hospital in Tehran, Iran, in 2015. In order to assess GERD symptoms, a standardized questionnaire of frequency scale (FSSG) was used before and after the intervention. Results: Regarding within-group changes, a significant decrease was observed in FSSG, dysmotility-like symptoms and acid reflux related scores in both groups of the study after the intervention compared to baseline (P < 0.001). Regarding between-group analysis, no significant differences were observed between the two groups in terms of FSSG total scores (0.05 < P). Conclusions: According to the results of the current study, Satureja hortensis L. with the dose of 500mgthree times per day failed to improve the symptoms of GERD in adults compared to placebo. The significant reductions in the GERD scores in both groups seem to be related to the lifestyle modification that was prescribed to both groups. © 2018, Iranian Red Crescent Medical Journal.

Prevalence and key radiographic spinal malalignment parameters that influence the risk for gastroesophageal reflux disease in patients treated surgically for adult spinal deformity

BackgroundGastroesophageal reflux disease (GERD) is a factor that has a significant negative impact on the quality of life (QoL). Vertebral fractures and/or spinal malalignment may influence the frequency of GERD. However, the epidemiology and pathology of GERD in patients with adult spinal deformity (ASD) are still largely unknown. To establish the optimal surgical strategy for GERD in patients treated surgically for ASD, we sought to clarify the GERD prevalence, determine radiographically which spinal malalignment parameters influence GERD risk, and evaluate GERD improvement postoperatively.MethodsSeventy-one consecutive patients with ASD who were treated with thoracolumbar corrective surgery and followed up for at least 1 year were enrolled. GERD was diagnosed by a gastroenterologist based on proton pump inhibitor medication response and/or an FSSG score > 8 points. Full-length lateral radiographs in a standing posture and in a supine, fulcrum backward-bending (FBB) position were taken preoperatively and 1 year postoperatively, and radiographic parameters were obtained. Correlations between radiographic parameters and FSSG scores were determined by Pearson’s correlation coefficient. Multivariate logistic regression analyses were performed to evaluate the odds ratio (OR) with a 95% confidence interval (95% CI) for potential risk factors for GERD.ResultsPatients were classified into two groups based on GERD symptoms, with 37 (52%) in the GERD+ group. Thoracolumbar kyphosis (TLK) in the FBB position was significantly more common in the GERD+ versus the GERD− group. Multivariate logistic regression analysis showed that lumbar lordosis (LL) and TLK curve in the FBB position significantly influenced the presence of GERD. Other factors showed no association with GERD. Significant improvements in FSSG scores were noted 1 year postoperatively. However, 20 (28.2%) patients still had GERD symptoms. The postoperative TLK curve was highly significantly correlated with FSSG scores 1 year postsurgery.ConclusionsOf the 71 patients treated surgically for ASD, 37 (52%) had a high frequency of GERD symptoms. An inflexible thoracolumbar curve with increased TLK in the FBB position was significantly associated with GERD symptoms. Despite significant improvements in FSSG scores postoperatively, insufficient correction of TLK might be a risk factor for persistent GERD symptoms.

Efficacy of vonoprazan for 24-week maintenance therapy of patients with healed reflux esophagitis refractory to proton pump inhibitors.

The aim of the present study was to evaluate the efficacy of a potassium-competitive acid blocker (P-CAB), vonoprazan, for the maintenance therapy of healed reflux esophagitis (RE). A total of 60 patients were enrolled in this open-label, single-center, prospective study. All patients were diagnosed with RE with a frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) total score ≥8 following treatment with standard proton pump inhibitors (PPIs) for a minimum of 8 weeks. Standard PPI treatment was switched to vonoprazan 20 mg once daily for 4 weeks. A total of 52 patients, who had no endoscopic evidence of erosive esophagitis following vonoprazan treatment, received maintenance therapy with vonoprazan 10 mg once daily for 24 weeks. Symptoms were evaluated using the FSSG and Gastrointestinal Symptom Rating Scale (GSRS). Upper gastrointestinal endoscopies were performed following 24 weeks of maintenance therapy. The primary endpoint was to determine the proportion of patients who exhibited maintenance of healed RE refractory to PPIs following 24 weeks of maintenance therapy with vonoprazan 10 mg once daily. Secondary endpoints included evaluation of the proportion of patients with symptomatic non-relapse at 24 weeks. Maintenance therapy with vonoprazan 10 mg once daily prevented relapse of esophageal mucosal breaks in 37/43 (86.0%) patients at 24 weeks. However, the number of patients with symptomatic relapse was 1 (1.9%) and 4 (7.7%) at 4 and 8 weeks, respectively. A total of 4 patients were withdrawn due to loss to follow-up. At the end of the 24-week maintenance period, the symptomatic non-relapse rate for acid reflux-associated and dysmotility symptom FSSG scores were 86.5 and 80.8%, respectively. Furthermore, the symptomatic non-relapse rate for reflux, abdominal pain, indigestion, diarrhea, and constipation GSRS scores at 24 weeks were 86.5, 80.8, 75.0, 71.2 and 76.9%, respectively. No serious adverse events were reported during the study. The mean gastrin level was 1,059 pg/ml. In conclusion, the results of the present study indicate that vonoprazan 10 mg once daily is effective for 24-week maintenance therapy of healed RE refractory to PPIs.

Higher frequency of upper gastrointestinal symptoms in healthy young Japanese females compared to males and older generations

BackgroundThe aim of this study was to evaluate the differences in upper gastrointestinal symptoms between generations and genders in relatively healthy Japanese subjects.MethodsAltogether, 4086 healthy Japanese male and female (M/F) adults (M/F: 2244/1842) were analyzed. Among them, 3505 subjects (M/F: 1922/1583) were underwent a routine medical checkup at one of five hospitals in Saga, Japan from January 2013 to December 2013. The others were 581 (M/F: 322/259) healthy young volunteers at the Saga Medical School from April 2007 to March 2013. The participants were asked to complete the frequency scale for the symptoms of gastroesophageal reflex disease (FSSG) questionnaire, undergo upper gastrointestinal endoscopy, and submit to a rapid urease test to diagnose Helicobacter pylori infection. Among the 4086 subjects, the 2414 who had no H. pylori infection and no positive endoscopic findings were enrolled in the study.ResultsSubjects’ average age was 46.9 ± 12.2 years, with males’ and females’ ages being almost equivalent. The total FSSG score were high in females compared to males (P < 0.01) and decreased significantly with aging (P < 0.05). Among the generations, FSSG scores were the highest for those 20–29 years old, and they were significantly decreased with ageing in both males and females (P < 0.05).ConclusionThe FSSG score was significantly higher in healthy Japanese females than in males, and the scores decreased with aging.

Yogurt Containing Lactobacillus gasseri Mitigates Aspirin-Induced Small Bowel Injuries: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Background: Although there is evidence about the beneficial effects of probiotics, their effects on aspirin-induced small bowel injuries have not been well examined. We evaluated the effects of the probiotic Lactobacillus gasseri OLL2716 (LG) on aspirin-induced small intestinal lesions, such as ulcers, erosions, reddened lesions, and bleeding. Summary: This study enrolled 64 patients who received aspirin for more than 1 month and provided written informed consent to be part of the study. The patients received 112 ml of yogurt containing LG or placebo twice daily for 6 weeks. Small bowel injuries were evaluated by capsule endoscopy before and after consuming the yogurt. The effect of LG on patient symptoms was also assessed using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) and Gastrointestinal Symptom Rating Scale (GSRS) questionnaires before and after 6 weeks of treatment. There was no significant difference in any baseline characteristics and the number of small bowel mucosal breaks between the 2 groups. In contrast with the placebo group, the LG group had significantly fewer small bowel mucosal breaks and reddened lesions after 6 weeks (p < 0.01). The FSSG and GSRS scores were also significantly improved in the LG group but not in the placebo group. Key Messages: This double-blind, placebo-controlled study found that LG may be useful in reducing aspirin-induced small bowel injuries and in mitigating gastrointestinal symptoms.

Landmark reading alterations in patients with gastro-oesophageal reflux symptoms undergoing diagnostic gastroscopy

Background and study aimsThere is still a debate about the exact measurement of the oesophagogastric junction and the diaphragmatic hiatus among clinicians. The aim of this study was to investigate the differences between landmark readings of gastroscopy on intubation and extubation, and to correlate these readings with a gastro-oesophageal reflux questionnaire. Patients and methods116 cases who underwent diagnostic gastroscopy between January 2013 and June 2013 were included in this study. Landmark measurements were noted while withdrawing the endoscope and were also evaluated after the gastric air was fully emptied. We first used a frequency scale for the gastro-oesophageal reflux disease symptoms (FSSG) questionnaire in order to investigate dysmotility and acid reflux symptoms in the study population and correlated the FSSG questionnaire with intubation and extubation measurements at endoscopic examination. ResultsMean age of included subjects was 49.41±17.7 (19–82) years. Males and females were equally represented. On FSSG scores, the total dysmotility score was 7.99±5.06 and the total score was 15.18±10.11. The difference between intubation and extubation measurements ranged from −3cm to +2cm (mean: −0.4). When an FSSG score of 30 was accepted as a cut-off value, we detected a significant difference between the measurements (p<0.05; t: 0.048). ConclusionAccuracy of landmark measurements during gastroscopy is clearly affected from insertion or withdrawal of the endoscope. When differences in measurements between insertion and withdrawal were evident, comparable with the FSSG scores, the results became significantly different. In conclusion, according to FSSG scores, these measurements should be performed at the end of the endoscopy.

Higher Frequency of Reflux Symptoms and Acid-Related Dyspepsia in Women than Men Regardless of Endoscopic Esophagitis: Analysis of 3,505 Japanese Subjects Undergoing Medical Health Checkups

Background/Aims: This study aimed at (i) clarifying the factors associated with high scores on the modified frequency scale for the symptoms of gastroesophageal reflux disease (FSSG) among 3,505 relatively healthy subjects undergoing routine medical health checkups with gastrointestinal endoscopy and (ii) comparing risk factors for high FSSG scores between subjects with and without reflux esophagitis. Methods: In total, 3,505 subjects (male/female: 1,922/1,583) who underwent upper gastrointestinal endoscopy during health medical checkups at 5 hospitals in Saga, Japan from January 2013 to December 2013 were enrolled. All subjects completed a modified FSSG questionnaire, which comprised 7 questions regarding reflux symptoms and 7 questions regarding acid-related dyspepsia. Each question was assigned a score based on the frequency of symptoms. Results: Younger age, female gender, hiatal herniation, and endoscopic reflux esophagitis were risk factors for a FSSG score with a high total. Subjects with high scores but without esophagitis were women, and hiatal herniation and Barrett's esophagus were frequently seen in patients with reflux esophagitis. Conclusion: Younger age, female gender, hiatal hernia, and endoscopic esophagitis were risk factors for a high FSSG score, and women tended to complain of upper gastrointestinal symptoms more frequently than did men among subjects without endoscopic esophagitis.

A comparative prospective study to assess the clinical efficacy and safety of pantoprazole monotherapy versus pantoprazole and itopride dual therapy in patients with gastroesophageal reflux disease in a tertiary care hospital

Background: Gastroesophageal reflux disease (GERD) is a common chronic, relapsing condition that carries a risk of significant morbidity and potential mortality from resultant complications. Proton pump inhibitors (PPIs) remained as the main stay in the therapy of GERD but they do not have any role in increasing the tone of lower esophageal sphincter which is the main pathophysiology of GERD. In this regard addition of prokinetic agent like Itopride may be beneficial in improving the symptoms associated with GERD. So the present study has been taken to compare the healing rates of esophagitis and reduction in symptom scores associated with GERD between Pantoprazole monotherapy and Pantoprazole plus Itopride combination. Methods: 100 patients diagnosed with GERD were randomly assigned into two groups, Group A and Group B. Group A received tablet Pantoprazole 40 mg twice daily alone and group B received tablet Pantoprazole 40 mg twice daily and tablet Itopride 50 mg thrice daily 30 minutes before food for 4 weeks. The patients were followed up at the end of 4 weeks and were given the questionnaire to assess the FSSG scores. Endoscopy and FSSG scores were recorded and then the percentage of responders in both groups was compared. Results: Endoscopic evidence of healing of esophagitis was similar in both the groups, 72% in Group A and 74% in Group B. The symptom relief was significantly more in Pantaprozole plus Itopride group 74.5% (4.2±1.6) than Pantaprozole alone 62.5% (6.4±1.1) after 4 weeks (p < 0.001).The occurrence of side effects was less in group B compared to group A (22% vs 30%, p= 0.172). Conclusions: Pantoprazole and combination of Pantoprazole plus Itopride provide more effective endoscopic healing of esophagitis. Pantoprazole and Itopride combination is more efficacious in ameliorating the symptoms of GERD than Pantoprazole alone.

Myrtus communis L. Freeze-Dried Aqueous Extract Versus Omeprazol in Gastrointestinal Reflux Disease: A Double-Blind Randomized Controlled Clinical Trial.

The current work assessed a pharmaceutical dosage form of Myrtus communis L. (myrtle) in reflux disease compared with omeprazol via a 6-week double-blind randomized controlled clinical trial. Forty-five participants were assigned randomly to 3 groups as A (myrtle berries freeze-dried aqueous extract, 1000 mg/d), B (omeprazol capsules, 20 mg/d), and C (A and B). The assessment at the beginning and the end of the study was done by using a standardized questionnaire of frequency scale for the symptoms of gastroesophageal reflux disease (FSSG). In all groups, both reflux and dyspeptic scores significantly decreased in comparison with the respective baselines. Concerning each group, significant changes were found in FSSG, dysmotility-like symptoms and acid reflux related scores. No significant differences were observed between all groups in final FSSG total scores (FSSG2). Further studies with more precise design and larger sample size may lead to a better outcome to suggest the preparation as an alternative intervention.

Irsogladine maleate and rabeprazole in non-erosive reflux disease: A double-blind, placebo-controlled study.

To evaluate the efficacy of adding irsogladine maleate (IM) to proton-pump inhibitor (PPI) therapy in non-erosive reflux disease (NERD) treatment. One hundred patients with NERD were recruited and randomized to receive rabeprazole plus IM (group I) or rabeprazole plus placebo (group P). The efficacy of the treatment was assessed using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) and the short form (SF)-36 quality of life questionnaires after four weeks of treatment. We also assessed whether patients with NERD with minimal changes (grade M) had different responses to the therapies compared with patients who did not have minimal changes (grade N). Group I and group P showed significant improvements in their FSSG scores after the treatment (from 17.9 ± 7.9 to 9.0 ± 7.6, and from 17.7 ± 7.3 to 11.2 ± 7.9, respectively, P = 0.0001), but there was no statistically significant difference between the FSSG scores in group I and those in group P. Subgroup analysis showed that significant improvements in the FSSG scores occurred in the patients in group I who had NERD grade N (modified Los Angeles classification) (7.8 ± 7.4 vs 12.5 ± 9.8, P = 0.041). The SF-36 scores for patients with NERD grade N who had received IM and rabeprazole were significantly improved in relation to their vitality and mental health scores. The addition of IM to rabeprazole significantly improves gastroesophageal reflux disease symptoms and the quality of the lives of patients with NERD grade N.

Pathophysiology of functional heartburn based on Rome III criteria in Japanese patients.

To investigate the pathophysiology of functional heartburn (FH) in Japanese patients. A total of 111 patients with proton pump inhibitor (PPI)-refractory non-erosive gastroesophageal reflux disease underwent intraesophageal pressure testing and 24-h multichannel intraluminal impedance-pH (24MII-pH) testing. The patients also completed several questionnaires while they were receiving the PPI treatment, including the questionnaire for the diagnosis of reflux disease (QUEST), the frequency scale for the symptoms of gastroesophageal reflux disease (FSSG), the gastrointestinal symptoms rating scale (GSRS), SF-36, and the Cornell Medical Index (CMI). The subjects were classified into FH and endoscopy-negative reflux disease (ENRD) groups based on the Rome III criteria. Thirty-three patients with esophageal motility disorder were excluded from this study, while 22 patients with abnormal esophageal acid exposure time (pH-POS) and 34 with hypersensitive esophagus (HE) were included in the ENRD group. The FH group included 22 patients with no reflux involvement. Sex, age, and body mass index did not differ significantly between the groups. The mean SF-36 values were < 50 (normal) for all scales in these groups, with no significant differences. The GSRS scores in these groups were not different and showed overlap with other gastrointestinal symptoms. The QUEST and the FSSG scores did not differ significantly between the groups. Neuroticism was diagnosed using the CMI questionnaire in 17 of the 78 included subjects within the pH-POS (n = 4), HE (n = 8), and FH (n = 5) groups, with no significant differences. Clinical characteristics of the FH and PPI-refractory ENRD groups were similar. Therefore, esophageal function should be examined via manometry and 24MII-pH testing to differentiate between them.

Treatment Option for Patients with Non-Erosive Gastroesophageal Reflux Disease Refractory to a Standard Proton Pump Inhibitor

Background: Non-erosive gastroesophageal reflux disease (NERD) resists treatment with standard proton pump inhibitor (PPI) doses in about 50% of patients. However, physicians do not have clear choices available for selecting alternative treatments for the refractory patients. Therefore, we investigated the effectiveness of double-dose PPI or a 5-hydroxytryptamine receptor antagonist (5HTRA) given with the standard PPI dose. Methods: We treated 10 NERD patients resistant to 10mg rabeprazole (RPZ) [RPZ(10)] with 20mg od RPZ [RPZ(20)] or 10mg od RPZ plus 5mg tid mosapride (RPZ-MOS) for 14-days in a cross-over manner. All patients' pHs were monitored for 24h and they were given a ＂Frequency Scale for the Symptoms of GERD＂ (FSSG) questionnaire to document their NERD symptoms, both on day 14. Results: The median FSSG score was significantly lowered by RPZ-MOS [7.0 (4-16), p＜0.01] and RPZ (20) [10.5 (1-28), p＜0.01] regimens compared with that for RPZ (10) [13.5 (10-31)]. However, FSSG scores were not significantly different between both regimens. The FSSG score was significantly associated with intragastric pH (p=0.02). The RPZMOS regimen's FSSG score was significantly correlated with RPZ (20) treatment (p=0.02). The FSSG scores of RPZ (10) in patients responsive to both regimens improved ≧30% compared with control scores. Conclusions: NERD patients whose FSSG score failed to decrease ≧30% after RPZ 10mg od treatment would be refractory to additional PPI or 5HTRA doses. FSSG scores after RPZ 10mg od treatment may provide a guideline for optimally treating NERD patients with a PPI.