Mild Dyspepsia Research Articles

The Efficacy and Safety of NOVAponin (Dolichos lablab Linne Extract Powder) in Mild Functional Dyspepsia: A Single-center, Randomized, Double-Blind, Placebo-controlled Study.

NOVAponin, a functional health food derived from Dolichos lablab Linne extract improves gastric mucosal injury and increases regeneration and proliferation. This study aims to investigate the efficacy and safety of NOVAponin in individuals with mild functional dyspepsia (FD). In this single-center, double-blind, randomized clinical trial, 131 patients with FD meeting the Rome IV criteria were enrolled. Changes in the gastrointestinal symptom rating scale (GSRS), FD-related quality of life (FD-QoL), gastrointestinal symptom (GIS) scores, inflammatory and anti-inflammatory markers, and adverse effects before and after administration were compared. After 12 weeks of administration, GSRS upper abdominal symptom scores were significantly improved in the test group compared to the control group (-5.30 ± 0.60 vs -2.35 ± 0.56, P < 0.001). GSRS upper abdominal symptom scores (-5.13 ± 0.55 vs -1.92 ± 0.44, P < 0.001), GSRS total scores (-7.02 ± 0.91 vs -3.33 ± 0.73, P < 0.001), GIS total scores (-11.21 ± 0.53 vs -6.65 ± 0.70, P < 0.001) after 6 weeks of administration, GSRS total scores (-7.54 ± 0.94 v. -3.31 ± 0.85, P < 0.001), GIS total scores (-11.90 ± 0.52 vs -7.61 ± 0.73, P < 0.001), and FD-QoL total scores (-11.41 ± 1.75 vs -5.55 ± 1.20, P = 0.007) after 12 weeks of administration also showed significant differences between groups. The differences were slightly more pronounced in epigastric pain syndrome subtypes and in females than the others, although more females were assigned to the test group. There were no significant changes in inflammatory and anti-inflammatory markers or adverse reactions. NOVAponin significantly improved mild FD symptoms especially in epigastric pain syndrome subtype and in females, and was found to be safe.

Unraveling the Mind-Gut Connection: Investigating Anxiety and Depression in Functional Dyspepsia

Psychological association with functional dyspepsia underscores the importance of a holistic approach to its management, addressing both physical and psychological aspects of the condition. Objective: To determine the relationship of anxiety and depression with severity of dyspepsia. Methods: A prospective cross sectional study was carried out in the Endoscopy Unit, Department of Gastroenterology, Baqai Medical Institute. All patients fulfilling the Rome III criteria for functional dyspepsia with normal endoscopy findings were included in the study, Pregnant females, patients with known diabetes, chronic kidney disease, chronic liver disease and known psychiatric illness, history of peptic ulcer disease and use of NSAIDs, steroids or alternative medicine were excluded. Severity of dyspepsia was assessed by Short Form Leeds Dyspepsia Questionnaire (SF-LDQ). Whereas hospital anxiety and depression scale (HADS) was used to assess the psychological factors. Results: A total of 223 participants were included in the study. Out of 223 participants, majority 55.6% (124) had moderate dyspepsia, followed by severe dyspepsia 26.9% (60), mild dyspepsia 12.6% (28) and very mild dyspepsia 4.9% (11). Using Hospital Anxiety And Depression Scale (HAD-S), we found that out of 223 participants, 56.5% (126) had moderate to severe anxiety and depression while 29.1% (65) had mild anxiety and depression. Conclusions: It was concluded that functional dyspepsia is clearly associated with common psychological disorders like depression and anxiety. Early recognition and timely linkage to care in such cases can considerably improve the health-related quality of life and hence decrease the global burden of this common disorder.

The prevalence and severity of upper gastrointestinal complications among patients with chronic diseases: a cross-sectional study from Palestine

BackgroundMany old people have at least one chronic disease. As a result, multiple drugs should be used. Gastrointestinal complications may occur because of the harmful effects of these chronic drugs on the stomach. The study aimed to assess the prevalence of upper gastrointestinal complications in patients taking chronic medications, the severity of these symptoms, and whether they take any gastro-protective drugs or not.MethodologyThis was a cross-sectional study through face-to-face questionnaires from internal outpatient clinics at a specialized hospital. Patients with chronic diseases who were taking at least one chronic medication were included in the study. Data Collection Form was used to gather information. The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) was used to evaluate the severity of the upper gastrointestinal symptoms. Statistical analysis was performed using the Statistical Package for Social Sciences (SPSS) version 21.ResultsA total of 400 patients with chronic diseases and using multiple medications were included. Among them, 53.8% were females and 56% were married, 58.5% were unemployed, 70% were not smokers, the mean age was 54.7 ± 17.5 years. The most common comorbid diseases among the patients were diabetes, hypertension, and arthritis, with percentages of 44.3%, 38%, and 27.3%, respectively. The mean number of chronic medications used was 3.36 ± 1.6 with a range of 1 to 9. The most commonly used was aspirin with a percentage of 50%, followed by atorvastatin, bisoprolol, and insulin with percentages of 29.5%, 25%, and 20.3%, respectively. Among the 400 participants, 362 (90.5%) suffered from upper gastrointestinal side effects like indigestion (65.8%), heartburn (78.3%), nausea (48.8%), and regurgitation (52.0%). Based on SF-LDQ scoring, of the 400 respondents, 235(58.8%), 109(27.3%) and 18(4.5%) suffered from mild, moderate and severe dyspepsia, respectively. A high percentage 325 (81.3%) of participants were prescribed gastro-protective medications. Proton pump inhibitors were the most prescribed group in 209 (52.3%) patients. Dyspepsia was significantly associated with older age (p-value = 0.001), being educated (p-value = 0.031), not being single (p-value < 0.001), having health insurance (p-value = 0.021), being a smoker (p-value = 0.003), and using ≥ 5 medications (p-value < 0.001).ConclusionUpper gastrointestinal complications among patients with chronic diseases were very common. Fortunately, the symptoms were mild in most cases. The risk increased with age and using a higher number of medications. It is important to review patients’ medications and avoid overuse of them, in addition to use gastro-protective agents when needed.

Suspected Hematuria: Adverse Effects of Rivaroxaban in Older Adult Treated for Atrial Fibrillation

Background: The modern concept of pharmaceutical healthcare implies monitoring the pharmacotherapy outcomes and reporting adverse drug reactions. Objective: To present a suspected hematuria as the adverse rivaroxaban reaction in a patient with atrial fibrillation observed by pharmacists in a community pharmacy. Case presentation: A 69-year-old female patient came to a pharmacy with a prescription for cranberry-based supplement. She was diagnosed with a mild urinary infection after experiencing blood in her urine for about two weeks. The pharmaceutical anamnesis revealed that the patient was treated with irbesartan and rivaroxaban. Rivaroxaban was applied for atrial fibrillation, and the patient was treated for nine months. The patient was treated with omeprazole gastro-resistant capsules for mild dyspepsia and stomach ache over a three-week period. The pharmacist counselled the patient to contact the clinician who introduced rivaroxaban, further suggesting substitution with different anticoagulant. Although the urine culture was negative, the physician introduced ciprofloxacin, which was followed by blood in the patient’s stool. Thus, gastroscopy, colonoscopy, and gynecological examination were advised. All findings were normal. Four days after rivaroxaban was substituted with acenocoumarol, no blood in the urine or stool was detected. Conclusions: Rivaroxaban can cause spot urine blood even when applied in therapeutic doses among older female patients when applied with omeprazole. Possible rivaroxaban interaction with omeprazole metabolites is suspected and should be carefully monitored.

Prospective proof-of-concept observational RESEarch about traditional herbal preparation Treatment for Chronic Obstructive Pulmonary Disease (RESET-COPD-1).

Despite advances in medical science, chronic obstructive pulmonary disease (COPD) continues to impact patients' lives significantly, due to symptom management limitations. Cheongsangboha-tang (CSBHT; Qing Shang Bu Xia Tang) and Hyunggaeyeongyo-tang (HGYGT; Jing Jie Lian Qiao Tang) have been used to treat respiratory diseases, including COPD. However, clinical data supporting their efficacy are lacking. We prospectively observed the response of patients with COPD to CSBHT and HGYGT as adjunctive therapies and assessed the feasibility of future research. Patients with COPD who were prescribed adjunctive HGYGT or CSBHT according to the COPD clinical practice protocol of Kyung Hee University Korean Medicine Hospital were recruited. Participants visited the hospital every month, for 6 months, to receive herbal preparations according to a Korean Medicine doctor's diagnosis and prescription and outcome evaluations. The primary outcome was the 6-min walking test (6-MWT). Secondary outcomes included the pulmonary function test (PFT), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), and modified Medical Research Council (mMRC) score. Syndrome differentiation, adverse events, and patient adherence were recorded. Thirty-seven patients were initially enrolled and followed up for a mean period of 154.1 days. CSBHT was prescribed to 36 patients, while one patient received either CSBHT or HGYGT, or both, throughout the entire period. During the herbal preparation treatment period, no statistically significant changes were observed in the 6-MWT. The CAT score (mean ± standard deviation) changed from 17.0 ± 5.0 to 12.5 ± 3.6, and the visual analogue scale score for dyspnea changed from 47.5 ± 18.9 to 28.4 ± 18.6 (both statistically significant from visit 5). The coronavirus disease 2019 pandemic precluded the PFT. SGRQ and mMRC scores did not change significantly. During the study period, seven patients dropped out, two experienced mild dyspepsia, and one experienced mild headache. No serious adverse effects were observed. We illustrated the therapeutic potential of CSBHT and provided preliminary clinical data on its efficacy and safety in patients with COPD. Our study highlights the need to derive optimal herbal formulations, which should be administered for an appropriate duration, based on the therapeutic goals for the treatment of COPD.

A study to assess the effectiveness of ginger tea on symptoms of dyspepsia among adults

Introduction: Dyspepsia is a common gastrointestinal (GI) condition around the world. Dyspepsia is a symptom complex that includes a variety of upper GI symptoms such as epigastric pain or burning, early satiety, and post-prandial fullness. Treatment with complementary and alternative medicines, particularly herbal remedies, is one option for treating dyspepsia symptoms. Objectives: The objectives of the study were to evaluate the effectiveness of ginger tea on symptoms of dyspepsia among adults Methods: A one-group pre-test and post-test research design with 30 samples who met the inclusion criteria was used. Demographic and clinical data were collected using a self-structured questionnaire. During the pre-test, a questionnaire (LDQ) was used to assess the severity of dyspepsia symptoms using an interview method. Following the pre-test, 100ml of freshly prepared ginger tea was given once a day, seven days a week, in the morning before meals. The same tool was used for the post-test after seven days of ginger tea administration. Data has been subjected to descriptive and inferential statistics Result: During the pre-test, 13(43.33 %) of the 30 samples had moderate dyspepsia, 9(30%) had severe dyspepsia, and 8(26.67%) had mild dyspepsia, whereas in the post-test, 14(46.67%) had moderate dyspepsia, 12(40%) had mild dyspepsia, and 4(13.33%) had severe dyspepsia. Ginger tea is effective when the pre-test and post-test values are compared. At the p&lt;0.001 level, the calculated paired ‘t’ test value of t = 9.104 was found to be statistically highly significant. Demographic variables such as marital status and clinical variables such as dyspepsia duration and smoking history show a significant association with post-test dyspepsia level at p&lt;0.05. Conclusion: According to the study findings, the overall pre-test symptom score was mild to moderate. The post-test symptom score of dyspepsia patients who were given ginger tea showed a significant reduction in symptom severity. It was concluded that ginger had a greater impact on symptom relief in dyspepsia patients than other foods.

A study to assess the effectiveness of ginger tea on symptoms of dyspepsia among adults

Introduction: Dyspepsia is a common gastrointestinal (GI) condition around the world. Dyspepsia is a symptom complex that includes a variety of upper GI symptoms such as epigastric pain or burning, early satiety, and post-prandial fullness. Treatment with complementary and alternative medicines, particularly herbal remedies, is one option for treating dyspepsia symptoms. Objectives: The objectives of the study were to evaluate the effectiveness of ginger tea on symptoms of dyspepsia among adults Methods: A one-group pre-test and post-test research design with 30 samples who met the inclusion criteria was used. Demographic and clinical data were collected using a self-structured questionnaire.During the pre-test, a questionnaire (LDQ) was used to assess the severity of dyspepsia symptoms using an interview method. Following the pre-test, 100ml of freshly prepared ginger tea was given once a day, seven days a week, in the morning before meals. The same tool was used for the post-test after seven days of ginger tea administration. Data has been subjected to descriptive and inferential statistics Result: During the pre-test, 13(43.33 %) of the 30 samples had moderate dyspepsia, 9(30%) had severe dyspepsia, and 8 (26.67 %) had mild dyspepsia, whereas in the post-test, 14(46.67%) had moderate dyspepsia, 12(40%) had mild dyspepsia, and 4(13.33%) had severe dyspepsia. Ginger tea is effective when the pre-test and post-test values are compared. At the p&lt;0.001 level, the calculated paired ‘t’ test value of t = 9.104 was found to be statistically highly significant. Demographic variables such as marital status and clinical variables such as dyspepsia duration and smoking history show a significant association with post-test dyspepsia level at p&lt;0.05. Conclusion: According to the study findings, the overall pre-test symptom score was mild to moderate. The post-test symptom score of dyspepsia patients who were given ginger tea showed a significant reduction in symptom severity. It was concluded that ginger had a greater impact on symptom relief in dyspepsia patients than other foods.

Multiple Duodenal Polyps in a Young Patient With Liver Cirrhosis

A woman in her mid-20s with recently decompensated liver cirrhosis secondary to autoimmune hepatitis was evaluated for liver transplantation. Esophagogastroduodenoscopy was performed to screen for esophageal/gastric varices. The patient had nonspecific mild abdominal pain and dyspepsia without diarrhea or constipation. Laboratory findings were remarkable for iron deficiency anemia with a hemoglobin level of 9.5 g/dL and a ferritin level of 10 μg/L. Esophagogastroduodenoscopy revealed multiple pedunculated polyps with superficial ulcerations ranging in size from 8 to 20 mm throughout the second part of the duodenum (Figure 1).

EGS P26 Audit of outcomes of Hiatus hernia repairs done as an emergency procedure in a tertiary care center

Abstract Background Hiatus hernia is the abnormal protrusion of stomach and /or intra-abdominal contents into the chest via a widened space between the diaphragmatic crura. Patients with hiatus hernias can present with a wide spectrum of symptoms ranging from a mild dyspepsia to acute presentations such as obstruction and strangulation. The recurrence rate, morbidity and mortality in patients requiring emergency surgeries in such acute presentations has been reported to be significantly high compared to that of elective hernia repair. We aim to assess the outcomes of hiatus hernia repairs done as an emergency surgery in a tertiary care center. Methods A retrospective study of all emergency hiatus hernia repairs done over a span of 10 years was done. Demographic details, BMI, smoking status, past medical history, method of diagnosis and management, duration of inpatient stay and the follow up was collected. The primary outcome of the study was 30 day mortality rate. Secondary outcomes were further surgeries during the same admission and recurrence rate. Results A total of 25 patients were identified to undergo an emergency hiatus hernia repair. 1 patient was excluded due to transfer to a different health board. 62.5%(n=15) of the patient were females. Duration of stay as inpatient ranged between 3 and 138 days. Of note, there were no deaths during the stay or recorded mortality by 30 days in the cohort. Conclusions The mortality rate in our unit is low in comparision with reported studies in literature.

Quality of life in Indian patients with functional dyspepsia: Translation and validation of the Hindi version of Short-Form Nepean Dyspepsia Index.

Patients with functional dyspepsia (FD) have poor health-related quality of life (HRQOL), but Indian data are lacking. Also, there is non-availability of validated disease-specific questionnaire to assess HRQOL in Hindi-speaking patients withdyspepsia. We aimed to develop and validate a reliable translation of Short-Form Nepean Dyspepsia Index (SF-NDI) in Hindi, and assess the impact of FD on HRQOL in Indian patients. Cross-cultural adaptation of English version of SF-NDI, translation to Hindi, and adaptation of Hindi version were performed using standard procedures. English and Hindi versions were assessed against Short Form-36 (SF-36), examining for internal consistency, test-retest reliability, and validity. Total 211 FD patients (144 Hindi speaking, 67 English speaking) were enrolled (mean age 40.8 ± 11.7years; male:female = 115:96). Median total SF-NDI scores for both languages were 38.75 and 40.0, respectively. Test-retest reliability intraclass correlation coefficients were 0.85 (Hindi) and 0.89 (English). Internal consistency evaluation revealed Cronbach's α coefficient of 0.79-0.86 (Hindi) and 0.78-0.89 (English). SF-NDI sub-scales showed moderate to good correlation with various domains of SF-36 (content validity). There was significant (p &lt; 0.001) decline of HRQOL in patients with severe dyspepsia relative to those with mild dyspepsia (construct validity). On multivariate analysis, factors independently associated with HRQOL were duration of symptoms and dyspepsia severity. Both English and Hindi versions of SF-NDI are reliable and valid for HRQOL assessment in Indian FD patients, and will be useful in future epidemiological and clinical studies. Indian FD patients have poor HRQOL, being worse in those with severe dyspepsia and longer duration of symptoms.

Long-term use of nonsteroidal anti-inflammatory drugs for pain control in patients with osteoarthritis: results of the 12-month observational study AELITA (Analgesia: Effective Treatment Using The Therapeutic Algorithm)

Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary means of managing chronic osteoarthritis (OA) pain. The choice of NSAIDs is based on an analysis of the risk of adverse reactions (ARs). Objective: to evaluate the efficacy and safety of long-term use of NSAIDs for pain control in patients with OA in real clinical practice.Patients and methods. To assess the results of long-term use of NSAIDs in OA, a 12-month observational non-interventional study was conducted. It included 611 patients with knee, hip and generalized OA, and nonspecific back pain associated with OA of the facet joints. All patients were prescribed aceclofenac (Aertal®) 200 mg/day. The patients' condition was assessed 2 weeks, 3, 6, 9 and 12 months after the start of therapy. The following parameters were determined: the intensity of pain during movement and the general health assessment (GA) according to the visual analogue scale (VAS, 10 cm); pain intensity according to the Likert verbal rating scale (VRS) (0–4); the number of patients with a pain reduction of ≥50% from baseline; patients' assessment of the result of therapy according to Likert VRS (1–5). The development of ARs was recorded at each visit.Results and discussion. By month 12, 46.8% of patients had dropped out of observation. In patients who continued the study, the average severity of pain according to the VAS at baseline, after 2 weeks, 3, 6, 9 and 12 months was: 6.5±1.2; 4.8±1.4; 3.2±1.4; 2.6±1.4; 2.2±1.1; 1.4±1.1 cm, respectively (significant differences compared to the baseline for all points – p&lt;0.05). The same differences were obtained in GA assessment.Within the indicated time frame, the number of patients with moderate / severe pain (on the Likert scale) decreased from 77.8 to 24.9; 2.9; 2.3; 0.9 and 0%, respectively. The number of patients with a pain reduction of ≥50% from baseline was 12.0; 65.1; 81.0; 88.5 and 84.0%, respectively. A good or excellent assessment of treatment results after 2 weeks was given by 63.3% of patients, and after 12 months – by 95.6%. ARs were observed in about 30% of patients, mainly mild or moderate dyspepsia (in 11.1–23.3%) and arterial hypertension (in 7.1–10.9%). No serious ARs were registered.Conclusion. Aceclofenac is an effective and relatively safe drug for the long-term management of chronic pain in OA.

Prevalence and severity of dyspepsia in Saudi Arabia: A survey-based study

Background and aimDyspepsia is one of the gastrointestinal diseases that is very common worldwide. Despite its prevalence globally, which ranges between 1.8% and 57%, no study has assessed the prevalence in Saudi Arabia. This study was aimed to investigate the prevalence and severity of dyspepsia in the general population of Saudi Arabia. MethodsA modified Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) was utilized to conduct our study. The questionnaire score ranges between 0 and 32, where zero indicated no dyspepsia, a score of 1–8 indicated mild dyspepsia, a score of 9–15 indicated moderate dyspepsia and a score of higher than 15 represented severe dyspepsia. Socio-demographic data of the participants including age, gender, marital status, BMI, job description, insurance, and education level were collected. Using Statistical Package for Social Sciences version 21.0 (SPSS), a univariate analysis was performed to assess the association of participants characteristics with the prevalence of dyspepsia, whereas logistic regression analysis was used to correlate their characteristics with the severity of dyspepsia. ResultsDuring a period of one month, March 1st to 31st 2019, a total of 778 participants have completed the survey. Most of them were females accounting for 68% of the population, married (63.9%), middle aged (range 34–51 years old) and literate with high school education (72.3%). Ninety two percent (92%) of the study population were found to experience dyspepsia. However, there is no significant association between socio-demographic characteristics and dyspepsia or its severity as well. ConclusionThe prevalence of dyspepsia in Saudi Arabia is the highest in the gulf region which would potentially lead to more GI complications, and associate to poor health and economic outcomes. Education programs are essential to raise the people awareness of dyspepsia and the appropriate ways to prevent it.

Evaluation of efficacy and safety of long-term use of amtolmetin guacil in rheumatic diseases: results of a 9-month observational AURORA study (Amtolmetin guacil: allRussian Register for Osteoarthritis, Rheumatoid arthritis and Ankylosing spondylitis)

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the treatment of rheumatic diseases (RD). In some cases, their long-term use is advisable: NSAIDs slow the progression of spondylarthritis, are an important element in the control of chronic pain in osteoarthritis (OA) and rheumatoid arthritis (RA). However, the risk of serious adverse events (AE) should be considered. A good choice for long-term therapy may be amtolmetin guacil (AMG), which rarely induce gastrointestinal AE.The aimof the study was to assess the effect and safety of long-term use of AMG in RD.Material and methods.An open observational study was conducted in which AMG (Nayzilat) was assigned to 442 patients with OA (mean age 60.6±10.2 years, women 88.7%), 126 patients with RA (55.0±14.0 years, women 84.2%) and 73 with ankylosing spondylitis (AS, 47.0±12.0 years, women 30.0%). The dose of AMG depended on the clinical situation and was determined by the attending physician: from 1800 to 600 mg/day. The main criterion of the effect was the changes of pain by numeric rating scale (NRS), additional measures of efficacy were pain on the WOMAC and HAQ for OA, DAS28 for RA, BASDAI, BASFI and ASDAS-CRP for AS. The result of treatment was evaluated during three consecutive visits every 3 months (9 months of follow-up).Results and discussion.At the end of follow-up 65.2% of patients with OA, 75.3% of patients with RA and 82.2% of patients with AS continued treatment with AMG. The reasons for discontinuation of treatment were significant reduction or absence of pain (70.3%), the patient's decision (26.6%) or AE (3.1%). At the end of follow-up, there was a significant decrease in pain intensity compared to the baseline: in OA, the median pain decreased from 5.6 [4.1; 6.9] to 3.4 [1.7; 5.1], in RA from 5.8 [4.0; 7.5] to 3.4 [2.0; 4.8], in AS from 5.8 [4.2; 7.5] to 3.1 [1.5; 5.0] according to NRS, the difference was significant in all groups (p&lt;0.001). In OA, the median WOMAC pain decreased from 127 [24; 159] to 13.7 [14; 40] (p&lt;0.001), the average HAQ value – from 0.54±0.44 to 0.34±0.26 (p&lt;0.001). In RA, the average value of DAS28 decreased from 4.81±1.18 to 4.30±1.24 (p&lt;0.05). The number of painful and swollen joints, ESR and C-reactive protein also significantly decreased. In AS, the median BASDAI index decreased from 4.5 [1.0; 8.0] to 3.0 [0; 8.0] (p&lt;0.001). The number of patients with high activity according to ASDAS-CRP (&gt;3.5) decreased from 76.9 to 25.8% (p&lt;0.001). The BASFI index did not changed. 77.9% of patients with OA, 77.0% with RA and 74.5% with AS were satisfied with the results of AMG treatment. AMG tolerance was good. Mild dyspepsia was observed in 15–25% of patients. AE, which caused the discontinuation of therapy, were observed only in 6 (0.93%) patients. There was no development or deterioration of hypertension, as well as other cardiovascular complications.Conclusion.AMG is an effective NSAID with good tolerability, which is advisable to use for long-term treatment of RD. Limitations are the open nature of the study and the absence of a control group.

The effect of Lactobacillus reuteri supplementation in Helicobacter pylori infection: a placebo-controlled, single-blind study

BackgroundHelicobacter 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.MethodsIn 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.ResultsAfter 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 δ value decreased by 22.5% during the Pylopass™ supplementation phase (− 3.14), while the mean 13C-UBT δ increased by 37.3% (+ 3.79) in the placebo phase. No side effects were reported in either study phase.ConclusionThe 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 registrationClinicaltrials.gov: NCT02051348 (January 30, 2014).

AB060. The effect of buspirone on refractory neurogenic retrograde ejaculation to pseudoephedrine

BackgroundThe use of sympathomimetics for the treatment of retrograde ejaculation (RE) is well-known, however the overall success rate does not exceed 50%. The aim of the present study is to evaluate the efficacy of buspirone (non-benzodiazepine anxiolytics) in neu.MethodsTotal 26 complete RE patients who were refractory to previous pseudoephedrine treatment included in the study. RE was diagnosed in patients who complained absence of ejaculated after orgasm and identified sperm in a post-ejaculatory urine sample. The patients who were taking alpha-adrenergic blocker and psychotropic medication, and who were taken the bladder neck or transurethral resection of the prostate, were excluded in this study. All patients were given buspirone 5 mg twice/day for 4 weeks. We evaluated the efficacy of buspirone by the establishment of antegrade ejaculate after 4 weeks of treatment.ResultsFive of 26 were excluded due to previous history of bladder neck surgery and psychotropic medication. The most common etiologies were diabetes mellitus (42.9%) and idiopathic (28.6%). Other etiologies were identified as follows: spinal cord injury (19.0%), Parkinson’s disease (4.8%) and multiple sclerosis (4.8%). Twelve of 21 patients (57.1%) were achieved antegrade ejaculation. One patient discontinued the study due to adverse events (developing dizziness) and one patient had mild dyspepsia; the remaining patients had no adverse drug-related events.ConclusionsIn patients with neurogenic RE, buspirone was effective for inducing antegrade ejaculation in more than 50% of patients. We suggest that if the first line treatments such as pseudoephedrine or imipramine are not effective, buspirone may be warranted.

X4P-001: A Novel Molecularly-Targeted Oral Therapy for Whim Syndrome

Background: WHIM syndrome (WHIMs; Warts, Hypogammaglobulinemia, Infections, Myelokathexis) is a rare autosomal dominant immunodeficiency disease attributable to mutations in CXCR4 . Most patients have severe neutropenia and lymphocytopenia with total white blood cell counts (WBC) <1.0 x 109/L. In general, children have more frequent and more severe infections than adults. Adults are at risk of human papilloma virus (HPV)-associated malignancies. There are no treatments approved for WHIMs although immunoglobulin and G-CSF are used to treat clinical symptoms of the disease. CXCR4 antagonists are being evaluated as a treatment for patients with WHIMs.Methods: We have begun the phase 2, dose-titration portion of a phase 2/3 study of a novel, orally bioavailable, selective, CXCR4 antagonist, X4P-001, in adult patients with genetically confirmed WHIMs to evaluate safety and tolerability of X4P-001 and determine the dose for a phase 3 study. All patients were required to be off chronic immunoglobulin and/or G-CSF treatment while on study. Patients receive increasing doses of X4P-001 ranging from 50 mg to 300 mg orally once daily with periodic monitoring of serial blood counts and intra-patient dose escalation is based on 24-hour serial area-under-the-curve (AUC) measurements of absolute neutrophil counts (ANC) and absolute lymphocyte counts (ALC) with prespecified thresholds.Results: As of July 10, 2017, 4 patients (2 females, 2 males; age range 19 to 57 years; 3 with R334X and 1 with E343X mutation) have been enrolled. The study entry screening WBC was 0.775 x 109/L +/-0.16 (mean +/- SEM); ANC was 0.125 x 109/L +/- 0.027; and ALC was 0.588 x 109/L +/- 0.155. All patients had mild hypogammaglobulinemia; the mean levels were: Immunoglobulin G 766 +/- 130 (SEM), IgA 50 +/- 17, IgM 74 +/- 13. In the 6 months prior to study entry, these adult patients had up to 6 episodes of infections, primarily upper respiratory and skin infections.Patients 1 and 2 have escalated through 50 mg/day and 100 mg/day to 150 mg/day over a total exposure period of 169 days. Patients 3 and 4 have escalated from 100 mg/day to 200 mg/day with an exposure period of 62 and 54 days, respectively. All patients have demonstrated a dose-dependent increase in ANC and ALC from screening values, with ALC increasing in greater proportion than ANC. At the 100 mg dose level, the pre-dose WBC was 1.24 x 109/L +/- 0.469 (mean +/- SEM) with peak levels of 2.8 x 109/L +/- 0.721 (increase=2.3 fold), the pre-dose ANC was 0.385 x 109/L +/- 0.178) with peak levels of 0.58 x 109/L +/- 0.202 (increase=1.5 fold) and pre-dose ALC was 0.728 x 109/L +/- 0.276 with peak levels of 2.143 x 109/L +/-0.513 (increase=2.9 fold). The increases in the pre-dose levels of both neutrophils and lymphocytes above the study entry screening values after 1-3 months on treatment suggest a continuing effect of daily exposure to this drug. However, the ANC and ALC responses thus far are below the targeted AUC for ANC and ALC, so dose escalation continues.Thus far, X4P-001 has been well tolerated and the most common treatment-related adverse events are mild dyspepsia and dry eyes. Patients have not required antibiotic treatment for infections during the cumulative 15 months on X4P-001, except for Patient 1 who had an infection at the start of the study.Conclusion: Preliminary data suggests X4P-001 is a promising oral agent for treating WHIM syndrome. DisclosuresDale:Sanofi Aventis: Consultancy, Editor, Current Opinions in Hematology, Honoraria; Cellerant: Membership on an entity's Board of Directors or advisory committees; Genzyme (now owned by Sanofi-Aventis): Consultancy, Patents & Royalties, Research Funding; Genkyotex: Other: DSMB (work completed 6/2015); Hospira: Consultancy; Prolong: Consultancy; Boheringer-Ingelheim: Consultancy; Coherus: Consultancy; Omeros: Other: DSMB; Shire: Other: Independent Review Board; X4Pharma: Research Funding; Philips: Research Funding; Wolter Kluwer: Other: Editor, Current Opinions in Hematology; WedMD/Medscape: Membership on an entity's Board of Directors or advisory committees; National Institutes of Health: Research Funding; University of Washington: Employment, Research Funding; American College of Physicians: Other: Editor and author; GlaxoSmithKline: Equity Ownership; Johnson&Johnson: Equity Ownership; Amgen: Consultancy, Research Funding. Johnson:X4 Pharmaceuticals: Employment. Gan:X4 Pharmaceuticals: Employment, Equity Ownership. Parasuraman:X4 Pharmaceuticals: Employment, Equity Ownership.

Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study.

Background: Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. Methods: We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Results: Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (−5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (−0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. Conclusion: GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

Risk factors and management for pyloric stenosis occurred after endoscopic submucosal dissection adjacent to pylorus.

Endoscopic submucosal dissection (ESD) has been widely accepted as a curative treatment for gastric neoplasm. Pyloric stenosis is a chronic complication that can be caused by ESD. The aim of this study is to clarify the risk factors and management for pyloric stenosis. From January 2004 to January 2014, a total of 126 patients who underwent ESD adjacent to pylorus were reviewed retrospectively. Pyloric mucosal defect was defined as when any resection margin of ESD was involved in the pyloric ring. Pyloric stenosis was defined as when a conventional endoscope could not be passed to the duodenum. Among the 126 patients, pyloric stenosis was identified in 9. In a univariate analysis, pyloric stenosis was more common in older patients (P < 0.05) and in lesions with resections over 75% of the pyloric ring circumference (P < 0.001). In a multivariate analysis, the factor that was associated with pyloric stenosis was the extent of the pyloric ring dissection (P < 0.001). Four of the 9 patients with pyloric stenosis had mild dyspepsia, and the others had gastric outlet obstruction symptoms. The 5 symptomatic patients underwent endoscopic balloon dilation (EBD), and the frequency of EBD was 1 to 8 times. The asymptomatic patients were treated conservatively. The incidence of pyloric stenosis was higher in lesions with resections over 75% of the pyloric ring circumference. Although EBD was an effective treatment for pyloric stenosis, conservative management was also helpful in patients who had mild symptoms.

Dyspepsia prevalence and impact on quality of life among Rwandan healthcare workers: A cross-sectional survey.

Dyspepsia has been demonstrated worldwide to have major personal and societal impacts, but data on the burden of this disease in Africa are lacking. To document the prevalence of dyspepsia and its quality-of-life impact among healthcare workers (HCWs) at Butare University Teaching Hospital (BUTH), Rwanda. A cross-sectional survey among consenting HCWs at BUTH was conducted. Multilingual interviewers guided participants through validated questionnaires, including the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ), to detect the presence and frequency of dyspeptic symptoms, and the Short-Form Nepean Dyspepsia Index (SF-NDI), to examine the impact of dyspepsia on quality of life. The study included 378 enrolled HCWs, all of whom provided responses to the SF-LDQ and 356 of whom responded to the SF-NDI. The prevalence of dyspepsia in the study population was 38.9% (147/378). Of these 147 HCWs, 79 (53.7%) had very mild dyspepsia, 33 (22.4%) had mild dyspepsia, 20 (13.6%) had moderate dyspepsia and 15 (10.2%) had severe dyspepsia. Females were more likely to complain of dyspepsia than males (98/206 v. 49/172; odds ratio (OR) 2.3; 95% confidence interval (CI) 1.5-3.5; p<0.001). Participants with dyspepsia of at least mild severity had SF-NDI scores reflecting reduced quality of life when compared with non-dyspeptic participants (OR 17.0; 95% CI 5.0-57.1; p<0.001), with most marked effects on the 'tension' and 'eating and drinking' subdomains of the SF-NDI. The prevalence of dyspepsia among HCWs in Rwanda is high and is associated with lowered quality of life.

The Use of Dabigatran for Prevention of Thromboembolic Complications in Patients Underwent Atrial Fibrillation Catheter Ablation

The aim of the study was to estimate the efficacy and safety of dabigatran in comparison with warfarin after atrial fibrillation (AF) catheter ablation (CA). 228 consecutive patients, having undergone AF CA, were enrolled in retrospective trial. In group I (n=170) warfarin was administered by modified interrupted scheme, in group II (n=58) dabigatran was administered by 150 mg twice a day. The main clinical efficacy and safety indicators were evaluated during the procedure and within 12 months after the procedure. There was no statistically significant difference between patients taking warfarin and dabigatran (p>0,1) in all of the investigated parameters, including the amount of bleeding and thromboembolic events. Side effects of mild dyspepsia were observed in the dabigatran group in 2.7% of the observations and in the warfarin group in 2.4% (p = 0,589). None of them required discontinuation of the therapy. Dabigatran can be considered as an alternative to warfarin for anticoagulation in patients undergoing AF CA.