Short-Form Leeds Dyspepsia Questionnaire Research Articles

A Clinical Study on the Efficacy and Safety of Poly-Herbal Formulation in Managing Functional Dyspepsia

IntroductionFunctional dyspepsia is a common condition that affects millions of people worldwide. It is characterized by symptoms such as abdominal discomfort, bloating, and nausea, which can significantly impact a person's quality of life. While there are several pharmaceutical treatments available, many individuals are turning to herbal remedies as a safer and more natural alternative. This clinical study aimed to evaluate the efficacy and safety of poly-herbal formulation (PHF), marketed under brand names like Dizester® Herbal, Great Day®, etc. in patients suffering from functional dyspepsia compared to Pantoprazole, a commonly used pharmaceutical treatment. Materials & MethodsThe study included 80 patients, with 40 patients in each treatment arm. The primary objective was to assess the improvement in symptoms using various questionnaires at All India Institute of Medical Science Bhubaneswar, including the Reflux Disease Questionnaire, Short-Form Leeds Dyspepsia Questionnaire, GERD-Health Related Quality of Life Questionnaire, visual analogue scale (VAS) for pain, and Investigator's Symptomatic Assessment. The secondary objective was to evaluate the safety of PHF by assessing liver and renal function parameters and hemogram. Results & discussionThe results showed significant improvement in symptoms of GERD in the PHF group, which was comparable to the Pantoprazole group. The burning feeling behind the breastbone, pain behind the breastbone, burning feeling in the center of the upper stomach, acid taste in the mouth, and unpleasant movement of material upwards towards the mouth improved significantly from the beginning of the study to the follow-up visits. The mean VAS score reduced by 71.5% in the PHF arm and 67.85% in the Pantoprazole arm. Additionally, the study found no abnormal elevations in liver and renal function parameters in blood or any abnormal changes in hemogram, indicating the safety for use in patients with functional dyspepsia. Since the synthetic anti-dyspeptic drugs like proton pump inhibitors are known to have adverse effects, this natural alternative PHF shows promising results in a safer way. ConclusionIn conclusion, this study provides evidence for the efficacy and safety of PHF in improving symptoms of functional dyspepsia. The use of synthetic anti-dyspeptic medications has been associated with the occurrence of undesirable effects. In light of this, PHF has demonstrated encouraging outcomes in a manner that is considered safer.

Relationship of Dyspeptic Symptoms with Dinner to Breakfast Time Interval

Objective: To ascertain the relationship of dyspeptic symptoms with dinner to breakfast time interval. Study Design: Cross-sectional study. Place and Duration of Study: Department of Gastroenterology, Liaquat National Hospital, Karachi Pakistan, from Aug 2021 to Apr 2022. Methodology: We enrolled patients of either gender, between 18 to 50 years of age, with persistent symptoms of dyspepsia for at least two months and/or confirmed cases of dyspepsia. Written, informed consent was taken from all patients prior to recruiting them. Patients visiting outpatient department with symptoms of dyspepsia and/or confirmed cases of dyspepsia were interviewed to fill out Short-form Leeds Dyspepsia Questionnaire (SF-LDQ). Results: Total 400 patients were studied with nearly half of the participants being female 188 (47%) with 72(18%), 87(21.8%), 113(28.2%) and 128(32%) patients had dinner to breakfast duration of ≤8 hours, 8.1-10 hours, 10.1-12 hours and >12 hours, respectively. There was moderate positive correlation between fasting duration and SF-LDQ (r=0.46, p<0.001). Nightly fasting duration of more than 10 hours had increased risk of indigestion, heartburn and regurgitation. Conclusion: Longer duration between dinner and breakfast was found to be associated with increased likelihood of dyspeptic symptoms including indigestion, heartburn and regurgitation.

Translation, cultural adaptation, and evaluation of the psychometric properties of the Arabic Gastroesophageal Reflux Disease Questionnaire (Ar-GerdQ).

Gastroesophageal reflux disease (GERD) is a common chronic digestive disease that affects people in different communities at different rates. Because of the absence of a validated Arabic tool to assess GERD symptoms, this study aimed to validate and culturally adapt the GERD questionnaire (GerdQ) tool to Arabic speakers. Patients referred for pH testing with symptoms suggestive of GERD were recruited. A cross-sectional study was conducted from March 2023 to April 2023 by administering the Arabic GERD questionnaire (Ar-GerdQ) tool on two different occasions and comparing it with the short-form leeds dyspepsia questionnaire and the Reflux Symptom Index to establish reliability and construct validity. A total of 52 participants were included in the study. The results of the internal consistency analysis of the Ar-GerdQ indicate that the test has good reliability, with a Cronbach's alpha coefficient of 0.86 (95% CI: 0.75-0.91). Significant positive correlations with the short form leeds dyspepsia questionnaire (r = 0.59, P < 0.001, 95% CI: 0.29-0.78) and the reflux symptom index (r = 0.47, P = 0.01, 95% CI: 0.13-0.71) were demonstrated. Moreover, the intraclass correlation coefficient value was 0.60 ( P < 0.001, 95% CI: 0.28-0.77), indicating a substantial level of agreement between the measurements. Our findings indicate that the Ar-GerdQ is useful for assessing reflux disease symptoms among Arabic speakers. Effective utilization of Ar-GerdQ will reduce unnecessary endoscopic requests in primary care settings.

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.

Efficacy and safety of alpha-pinene capsule in the management of functional dyspepsia and eradication of helicobacter pylori: a randomized clinical trial.

Our objective was to assess the efficacy and safety of adding alpha-pinene (a herbal terpenoid) to quadruple therapy compared to a placebo in improving symptoms and Helicobacter pylori (H. pylori) eradication rates in Functional dyspepsia (FD) patients. FD is a prevalent upper gastrointestinal condition, and no definitive pharmacological treatment is available for its management. We conducted a randomized, double-blinded, placebo-controlled trial on FD patients diagnosed with H. pylori infection. We collected baseline demographic data and assessed FD symptoms in the participants. Patients were randomly allocated to receive either standard quadruple therapy with α-pinene capsules (0.25 mg/day) or quadruple therapy with a placebo for two weeks. We employed a validated questionnaire, the Short Form Leeds Dyspepsia Questionnaire (SF-LDQ), to evaluate FD symptoms. The eradication rate of H. pylori was compared between the two groups one month after completing the treatment regimens. Any reported adverse drug reactions (ADRs) were documented throughout the trial. Over four months, a total of 66 patients completed the trial. Notably, there were no significant differences in baseline SF-LDQ scores between the two groups (p=0.83); however, a significant divergence emerged at the trial's conclusion (p=0.03). The H. pylori eradication rates did not show notable differences between the two treatment arms (p=0.43). Importantly, there were no dropouts from the trial due to ADRs. Among reported ADRs, participants experienced abdominal pain, headache, diarrhea, and a metallic taste, with no significant variance in incidence rates observed between the two groups (p=0.62). These findings suggest that α-pinene could be an effective and safe agent for reducing FD symptoms.

Sequential therapy versus quadruple therapy for Helicobacter pylori eradication: A prospective double-blinded randomized controlled trial.

This controlled randomized clinical trial was designed to compare effectiveness, side effects, and severity of symptoms before and after therapy between quadruple (QT) and sequential regimens (SQ) for Helicobacter Pylori (H. pylori). Patients were randomly allocated into two groups. Group A received a 14-day QT including pantoprazole 40 mg q12 h, bismuth subcitrate 240 mg q12 h, clarithromycin 500 mg q12 h, and amoxicillin 1000 mg q12 h and group B received ST including pantoprazole 40 mg q12 h and amoxicillin 1000 mg q12 h for the initial 5 days followed by pantoprazole 40 mg q12 h, clarithromycin 500 mg q12 h and tinidazole 500 mg q12 h for the next 5 days. Adverse drug reactions and patients' compliance were assessed after finishing the treatment course and also 4 weeks after. All patients were naive, therefore ST and QT were first-line therapies. To evaluate severity of symptoms we used Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) before taking the first dose of regimens, at the end of therapy, and also 4 weeks after (follow-up). The mean age in Group A (n = 83) was 48.55 ± 12.56 and 47.24 ± 12.78 in Group B (n = 79). No statistically significant differences were observed between the two groups regarding age, gender, endoscopic findings, and also eradication rate. The analysis demonstrated a significant decrease in SF-LDQ score between baseline and after therapy and baseline and follow-up in both regimen groups. Both regimens were well tolerated by the majority of patients, and there were no significant differences between the two groups in terms of adverse drug reactions. This study showed that ST can be used as an alternative first-line therapy to QT in patients with H. pylori infection.

Clinical, Endoscopic and Histopathological Patterns among Patients with Dyspepsia

Aim: Dyspepsia is a term differently understood, and associated with various upper gastro-intestinal endoscopic and histopathologic patterns. Most patients have regarded upper abdominal pain as ‘peptic ulcer disease’ with resultant late presentation of upper gastro-intestinal malignancies in some cases. This study examined the clinical presentation, endoscopic and histopathological patterns among patients with dyspeptic symptoms in Nnewi, South-East Nigeria.&#x0D; Methods: This hospital based descriptive cross-sectional study examined 352 patients presenting with dyspepsia. Abdominal ultrasound was used to exclude patients with dyspepsia of biliary or pancreatic origin. An interviewer administered questionnaire (using the short form Leeds dyspepsia questionnaire) was used to describe dyspepsia patterns, and gastroscopy done on the included patients following an overnight fast. Samples obtained from endoscopy were assessed histologically for morphology and presence of H. pylori organism.&#x0D; Results: Most participants belonged to 55 to 74 years age group with a mean age of 52.27±2.59 years. Epigastric discomfort (96.9%), heart burn (63.1%) and belching (55.4%) were the commonest symptoms. The commonest endoscopy and histopathologic findings was chronic gastritis (63.06% and 51.99% respectively), although there was poor agreement between the two modalities.&#x0D; Conclusion: Histology remains the goal standard for diagnosis. However, we recommend endoscopy for dyspeptic patients especially in the elderly to enhance early detection of cancers, which were significant in this study.

Dyspeptic Symptoms in Type 2 Diabetes Patients

Background: Nearly half of the patients with diabetes experience diabetic gastroparesis. Some diabetic patients present with complaints of epigastric pain, vomiting, nausea, or postprandial fullness, however only a few have severe symptoms. Objective: To determine the frequency of dyspepsia among T2DM patients. Methods: This cross-sectional study was performed in Ziauddin Hospital Kemari Branch, Karachi, Pakistan after acquiring ethical approval from the hospital ethics committee. Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) was used to identify the presence of dyspepsia. Based on the sum of the frequency of symptoms, a cut-off value of 4 and above was used for the presence of dyspepsia. Results: A total of 368 patients were included in the study with a median age of 68.6 ± 14.2 years. The majority were females (62.8%). The mean duration of diabetes was 15 ± 10.4 years. The frequency of indigestion, heartburn, regurgitation, and nausea was 35.3%, 30.7%, 31.5%, and 11.4% respectively. Out of 368, 168 (45.7%) patients were found to have dyspepsia. The risk of dyspepsia was significantly lower among younger age, male gender, and patients having controlled glycemic status, patients doing physical activity twice a week, taking all three meals on time, and always having their breakfast early. The odds of having dyspepsia were higher among those who are currently and formerly addicted to alcohol, current and former smokers, having comorbidity, consuming &lt;8 glasses of water per day, and those who were always or sometimes sleeping within two hours of having dinner. Conclusion: This study analyzed that dyspeptic symptoms including indigestion, heartburn, and regurgitation were common in T2DM patients, and about half of these patients had dyspepsia which was common among patients with poor glycemic control and those with unhealthy lifestyles.

Correlation of Dyspepsia with the type of First Meal of the Day; Breakfast or Brunch: A Cross-Sectional Study from Karachi Pakistan

Background: Breakfast skipping is traditionally viewed as a bad habit. The customary choice for those who skip breakfast is brunch. Changes in gastrointestinal function are correlated with a range of dietary factors. Objective: To evaluate the correlation of the type of first meal of the day with dyspepsia among patients visiting gastroenterology clinics with dyspeptic symptoms. Methods: This cross-sectional study was conducted in the Department of Gastroenterology, Liaquat National Hospital from August 2021 to April 2022. Short-Form Leeds Dyspepsia Questionnaire was used to identify the presence of dyspepsia (SF-LDQ). Breakfast was defined as the meal consumed in the morning and any beverages or food taken in the morning before 11:00 a.m. regularly in a week. Data were analyzed using the statistical package SPSS version 21. Results: A total sample of 390 patients were analyzed in this study with median age and duration of symptoms 35 (IQR=26-42) years 12 (IQR=8-24) months respectively. The frequency of breakfast skipping was 15.6%. The frequency of dyspeptic symptoms including indigestion, heartburn, regurgitation, and nausea was significantly higher among patients taking brunch as the first meal of the day than those who were having breakfast regularly. The frequency of dyspepsia was 75.1%. On univariate and multivariable analysis, the practice of consuming breakfast regularly was found to be associated with a lower risk of dyspepsia than those who were consuming brunch as the first meal of the day. Conclusion: The current study analyzed that type of first meal was significantly associated with dyspepsia. The frequency of dyspeptic symptoms was significantly higher among patients taking brunch at least once a week than patients who were regularly consuming breakfast.

Therapeutic effects and central mechanism of acupuncture and moxibustion for treating functional dyspepsia: study protocol for an fMRI-based randomized controlled trial

BackgroundFunctional dyspepsia (FD) is one of the most common functional gastrointestinal disorders, with a high prevalence and significant influence on the quality of life (QoL). Either acupuncture or moxibustion is effective for dyspepsia, which is confirmed by both ancient documents and modern research. However, the therapeutic advantage and underlying mechanism between acupuncture and moxibustion for FD remain unclear.MethodsThis randomized controlled fMRI trial aims to (i) evaluate the therapeutic advantages of acupuncture and moxibustion treatment for FD, (ii) investigate the similarities and differences in cerebral activity elicited by acupuncture and moxibustion, and (iii) analyze the possible correlations between brain responses and clinical variables thus to explore the potential central mechanism of acupuncture and moxibustion for treating FD. Ninety-two FD patients will be randomly assigned to either the acupuncture group or the moxibustion group in a 1:1 ratio. Twenty sessions of acupuncture or moxibustion treatment over 4 weeks will be performed on each patient. The short form Leeds Dyspepsia Questionnaire, the Nepean Dyspepsia Index, etc., are used to evaluate the therapeutic effects. The heart rate variability will be analyzed to investigate the autonomic nerve function. Thirty-six FD patients in each group will be randomly selected for the fMRI scan to detect cerebral activity changes.DiscussionWe expect the results will deepen our knowledge on the clinical value and underlying mechanism of acupuncture and moxibustion and provide a reference for a better selection of interventions for treating FD.Trial registrationChinese Clinical Trial Registry (www.chictr.org.cn) ChiCTR2100049496. Registered on 2 August 2021

A34 GLUTEN-FREE DIET IMPROVES DYSPEPTIC SYMPTOMS IN PATIENTS WITH TYPE 1 DIABETES IN WHOM CELIAC DISEASE WAS EXCLUDED

BackgroundPatients with type 1 Diabetes Mellitus (T1DM) often suffer from dyspeptic symptoms, such as abdominal pain, bloating, early satiety, nausea and vomiting. T1DM shares genetic risk factors (HLA-DQ2 and DQ8) with celiac disease, an autoimmune disorder caused by an immune reaction to gluten. Patients with concomitant T1DM and celiac disease benefit from a gluten-free diet (GFD), as it improves their symptoms, gastric emptying and small intestinal inflammation. However, it is unknown whether GFD has any benefit in patients with T1DM without celiac disease, who present with symptoms of dyspepsia or gastroparesis.AimsTo investigate the role of a GFD in the management of moderate to severe dyspeptic symptoms in non-celiac patients with T1DM.MethodsWe enrolled 13 adult T1DM patients, in whom celiac disease was ruled out, suffering from two or more upper GI symptoms. The patients were instructed to adhere to a strict GFD for a period of 1 month, under the supervision of a dietitian. Glycemic levels were monitored by a continuous glucose monitoring device (CGM) for 2 weeks before, and at the end of the GFD period. Standardized questionnaires were used to assess upper GI symptoms (Gastroparesis Cardinal Symptoms Index, Short Form Leeds Dyspepsia questionnaire), general quality of life (Patient Assessment of Upper GI Disorders Quality of Life), and anxiety and depression (Hospital Anxiety Depression scale). Blood samples were collected to assess glycaemia (Hb1Ac) and immune markers. Scintigraphy and videofluoroscopy were used to assess gastric emptying.ResultsAfter one month on a GFD, T1DM patients reported a significant improvement in nausea (p<0.05), sensation of fullness (p<0.001) and bloating (p<0.0001). Overall dyspepsia symptoms also improved (p<0.01), with 92% of patients reporting decreased dyspepsia scores. Moreover, there was an improvement in the quality of life (p<0.01), and decreased scores of anxiety and depression (p<0.01 and p<0.05, respectively). There were no changes in gastric emptying or glycemic management metrics, such as mean glucose level, time in target, glucose variance or HbA1c levels. Interestingly, one year after the end of the study, 63.6% of participants continued to follow a GFD. The most common reason to remain on a GFD reported by these patients was “because it improved GI symptoms”. Questionnaire data collected at the follow-up demonstrated that the improvement of dyspeptic symptoms persisted after 1 year on GFD (p<0.001).ConclusionsGFD improves dyspeptic symptoms in T1D patients without concomitant celiac disease, without affecting their glycemic levels or gastric emptying. Although these results need to be validated in a larger study, our data suggest that GFD could be used as a therapeutical tool for T1DM patients grappling with burdensome upper GI symptoms. Gluten-Free diet improves dyspepsia symptoms in Type 1 Diabetes patients, after 1 month and 1 yearFunding AgenciesCIHR

Management of Dyspepsia with Enterica®, Dyspepsia® and Natural Pain Killer® herbal-combination at the Centre for Plant Medicine Research Clinic, Ghana

IntroductionThis observational study validated the efficacy of a combination of three herbal preparations (Mist Dyspepsia®, Mist Enterica®, and Natural Pain Killer® (NPK)) in patients with symptoms of dyspepsia who visited the Clinic of the Centre for Plant Medicine Research (CPMR), Mampong-Akuapem, Ghana. MethodThe Short Form Leeds Dyspepsia Questionnaire (SF-LDQ) was used to assess the presence, severity, frequency, and the most troublesome symptoms in patients diagnosed with dyspepsia at the CPMR Clinic. The patients were put on Dyspepsia®, Enterica®, and Natural Pain Killer® (NPK). ResultsA total of 162 patients were enrolled in the study. This included a hundred and seven (107, 66%) females and fifty-five (55, 34%) males with a mean age of 36.79 years. The Cronbach’s alpha reliability test value was 0.74 indicating the reliability of the SF-LDQ. The prevalence rate of dyspepsia among the study participants on the day of recruitment was 98.7% (160/162). Almost 80% of study participants were classified as having severe or moderate dyspepsia. The presence or absence of Helicobacter pylori infections did not affect the dyspepsia severity. The most troublesome dyspeptic symptom was indigestion. There was a significant reduction in the severity of dyspepsia at the end of the study (p = 0.001) with no serious side effects. ConclusionDyspeptic patients at the CPMR-Clinic had improved symptoms as indicated by the reduction in the frequency and severity after treatment with the combination of Mist Dyspepsia®, Mist Enterica®, and Natural Pain Killer® (NPK).

Effectiveness of Buspirone in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study.

BACKGROUND Functional dyspepsia (FD) is a relatively common disorder whose pathogenesis has yet been poorly understood. There are still debates concerning definitions and the best possible treatments for this disorder. We aimed to assess the effectiveness of buspirone, a 5-hydroxytryptamine (HT)1A agonist, in improving the symptoms and quality of life (QoL) as well as psychological dimensions in patients with FD. METHODS This study was a randomized, double-blinded, placebo-controlled trial performed on 30 patients with FD, residing in the city of Sari, northern Iran, from December 2017 to October 2018. Consecutive patients referring to a tertiary hospital with a clinical diagnosis of FD, according to the Rome IV criteria, were recruited. All patients were ethnically Persian and had normal upper endoscopy and negative histological evaluation results for any gastrointestinal disease or helicobacter pylori (H. pylori) infection while evaluating biopsy samples endoscopically. Exclusion criteria were being diagnosed with major psychiatric disorders, suicidal thoughts, recent treatments with psychoactive drugs, as well as major cognitive impairments. Patients were randomly assigned to receive either buspirone (n=18) or placebo (n=12) for two months. The first group received buspirone 5mg three times a day for the first month and 10mg three times a day for the second month. During the treatment course, the patients were advised to report any adverse reactions. Also, both groups were evaluated by three questionnaires [demographic characteristics form, the 36-Item Short-Form Health Survey (SF-36), The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) and Hospital Anxiety and Depression Scale(HADS)] at the baseline and at the end of the 8th week by a blinded psychologist. Finally, data were analyzed using SPSS software (version 18). P values <0.05 were considered statistically significant. RESULTS The most common symptoms of the patients were FD followed by heartburn. No significant differences were observed between buspirone and placebo groups regarding QoL (p=0.58), anxiety and depression (p =0.36), and severity and frequency of FD symptoms (p =0.22) before and after the intervention. In both groups, the overall QoL as well as HADS and SF-LDQ scores had significantly improved at the end of the study compared with the baseline. CONCLUSION Our findings indicate no significant effects associated with buspirone on the clinical course of FD, compared with placebo. More studies are needed to introduce effective therapies according to the pathophysiology of FD.

Validation of the Arabic version of the Short Form Leed's Dyspepsia Index (SF-LDQ) amongst patients with type II diabetes

Since an unambiguous clinical definition of dyspepsia does not currently exist, the diagnosis is made on the basis of symptoms. For this purpose, a tool which is valid, reliable and convenient to use is needed that can accurately assess both frequency and severity of dyspepsia. Short-Form Leeds Dyspepsia Questionnaire meets all of these requirements and thus, has to be validated in native languages before it can be used to diagnose dyspepsia. We conducted a cross-sectional study at King Abdullah Bin Abdulaziz University Hospital (KAAUH) in Riyadh, Saudi Arabia. Adult patients with type II diabetes were recruited in the study after giving informed consent. A total of 245 patients were recruited in the study; 95 (38.8%) were males, while 149 (61.1%) were females. We found that 27.3% (n = 67) of the participants had dyspepsia according to the SF-LDQ Arabic version compared to 24.1% (n = 59) by physician's diagnosis. The Area Under the Curve was 0.86 (95% CI: 0.81–0.9). At a cut-off value of 7/32, the tool has a sensitivity of 69.49% and a specificity of 83.24%. In conclusion, The Short-Form Leeds Dyspepsia Questionnaire was found to be valid for assessment of frequency and severity of dyspepsia among Arab diabetes Type 2 patients.

Efficacy and Safety of Fingerroot (Boesenbergia rotunda) Extract in Patients with Functional Dyspepsia: A Randomized, Placebo-Controlled Trial

Background: Functional dyspepsia (FD) is a common upper gastrointestinal disorder, but the current treatments are still unsatisfactory. Fingerroot (Boesenbergia rotunda [L.] Mansf.; BR) is used as a traditional medicine for dyspepsia despite a lack of proven evidence. Objective: This study aimed to evaluate the efficacy and safety of BR extract in the treatment of patients with FD. Methods: In a randomized, double-blinded, placebo-controlled trial, 160 patients with FD based on Rome IV criteria were to be recruited and randomly assigned (1:1 ratio) to receive BR (350 mg extract powder) or placebo 3 times daily for 4 weeks. Primary end point was change in the summed total score of Short-Form Leeds Dyspepsia Questionnaire. Secondary end points were the rate of symptom relief, the reduction of blood inflammatory markers and the improvement in gastric histology according to the Updated Sydney System. Results: One hundred sixty patients (62 [38.8%] men, aged 56.9 ± 14.8 years) were randomized to the BR group (n = 80) and placebo group (n = 80), and 138 patients completed this study. Overall symptom improvement was significantly greater in the BR group than in the placebo group (−7.1 ± 2.0 vs. −3.7 ± 0.8, repeated measures ANOVA, p < 0.05). Total symptom scores significantly improved with decrease in blood inflammatory markers in the BR group compared with the placebo group (p < 0.05). Proportion of responders was higher in the BR group (58%) than in the placebo group (34.6%) according to the intention-to-treat analysis (p < 0.05) with the number needed to treat calculated as 4.3. No difference in gastric histology was observed in both groups. BR extract was well tolerated with few adverse events. These effects were associated with acute phase reactants reduction. Conclusions: BR extract represents an effective and safe alternative to manage dyspepsia symptoms in FD patients.

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.

Prevalence and sociodemographic determinants of dyspepsia in the general population of Rwanda

IntroductionDyspepsia accounts for a significant burden of worldwide disease, but there is a relative paucity of data from the sub-Saharan African setting. We undertook to describe the burden, risk factors...

Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study.

Functional dyspepsia (FD) is a highly prevalent disorder having nonspecific symptoms and varied pathophysiology. Its treatment remains a challenge as therapeutic options are limited, unsatisfactory, and elusive. Thus, safety and efficacy of DigeZyme®, a proprietary multienzyme complex (MEC), was evaluated as a dietary supplement in FD patients. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 patients were randomly assigned (1:1 ratio) to receive either MEC (50 mg, TID; n = 20) or placebo (n = 20) for 60 days. Reports of adverse or serious adverse events (AEs), abnormal results of vital signs, abnormal findings during physical examination, and abnormal laboratory investigations were monitored closely. Efficacy measures were change in Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ), Nepean Dyspepsia Index-Short Form (NDI-SF), Visual Analog Scale (VAS), Clinical Global Impression Severity Rating Scale (CGI-S), and Glasgow Dyspepsia Severity Score (GDSS) at baseline and follow-up visits on day 15, 30, and 60. Supplementation with MEC was associated with statistically significant differences (P value ranging from .0401 to .0033) in all efficacy parameters compared with placebo. The between-group comparison also revealed that MEC supplement had a significantly greater effect (P < .001) versus placebo. No investigation product-related AEs were reported. There were no clinically significant abnormalities in physical findings and no statistically significant changes in biochemical and hematological parameters, vital signs, body weight, and body mass index observed between the two groups at baseline and follow-up visits. MEC supplementation represents an effective and safe alternative to manage dyspepsia symptoms in FD patients.

The central mechanism of acupuncture treatment with a long-lasting effect for functional dyspepsia: study protocol for a randomized controlled trial

BackgroundThe mechanism of the long-lasting effect and the relationship between the long-lasting effect and the deqi sensation, which is the key of achieving the acupuncture effect, has not been well investigated. This trial focuses on investigating the possible central mechanism of the long-lasting effect influenced by the deqi sensation.MethodsA randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 105 functional dyspepsia (FD) patients will be allocated into three groups: an acupuncture with deqi group, an acupuncture without deqi group, and a wait-list group. This trial will include a 2-week baseline period, a 4-week treatment period, and a 4-week follow-up period. During the 4-week treatment, patients in two acupuncture groups will receive 20 sessions of acupuncture treatment with or without deqi. The Nepean Dyspepsia Index (NDI) and the short form Leeds Dyspepsia Questionnaire (SF-LDQ) will be used to evaluate the clinical efficacy of acupuncture treatment at baseline, the end of treatment, and the end of the follow-up. Functional magnetic resonance imaging (fMRI) scans will be performed to detect cerebral functional changes in 25 patients in each group at three time points mentioned above. The clinical data and fMRI data will be analyzed, respectively. Correlation analysis will be conducted to investigate the relationship between cerebral functional changes and symptom improvement.DiscussionThe results of this trial will allow us to compare the changes of acupuncture therapeutic effect at three time points (the baseline vs. the end of treatment vs. the end of follow-up), and investigate the potential central mechanism of the long-lasting effect influenced by acupuncture with deqi. This trial aims to re-identify the long-lasting effect of acupuncture and investigate its central mechanism, and to further explore the central influence of deqi sensation on the long-lasting effect.Trial registrationChinese Clinical Trial Registry, IDF: ChiCTR-IOR-15006523. Registered on 5 June 2015.