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List of functional dyspepsia signs and symptoms. *Percentages represent frequency of participant ( N =45) report during concept elicitation interviews † ( 2 ).
Source publication
Objectives:
The Functional Dyspepsia Symptom Diary (FDSD) was developed to address the lack of symptom-focused, patient-reported outcome (PRO) measures designed for use in functional dyspepsia (FD) patients and meeting Food and Drug Administration recommendations for PRO instrument development.
Methods:
Concept elicitation interviews were conduc...
Similar publications
Background: Functional dyspepsia (FD) is one of the most critical health problems worldwide. Although there has been an increased intervention to improve FD symptoms, it is difficult to compare the effect of intervention measures with the existing methods of reporting the outcome, and it is a lack of clinical evaluation tools that can be used to ev...
Citations
... The FD Symptom Diary (FDSD) is newly developed and easy to conduct patient-reported outcome (PRO) measurement designed for use in patients with FD and meeting US Food and Drug Administration (FDA) recommendations (13). Here by using the modified FDSD as a tool to evaluate the treatment effect on FD, we conducted a multicenter, randomized controlled trial, aiming to investigate the effectiveness of taVNS with different frequency on adult patients with FD. ...
... The details of contents, possible limitations, previous validation, and uses in clinical research were summarized in Supplementary Digital Content (see Supplementary Table 1, http://links.lww.com/AJG/D82). The grade of dyspepsia in this study was modified from FDSD dyspepsia questionnaire (13,28). It has 5 cardinal items (stomach pain, burning in the stomach, bloating, early satiety, and postprandial fullness) and 3 supplementary items (nausea, burping/belching rating, and burping/ belching bother). ...
Introduction
Vagal nerve stimulation (VNS) can be used to modulate GI motility, inflammation, and nociception. However, it remains unclear whether VNS is effective in adult functional dyspepsia (FD) patients. Here we investigated the effectiveness of transcutaneous auricular VNS (taVNS) in FD patients.
Methods
Consecutive FD patients meeting Rome IV criteria with modified Functional Dyspepsia Symptom Diary (FDSD) score ≥10 were enrolled. Patients were randomly allocated to 10Hz taVNS (V10 group), 25Hz taVNS (V25 group), or sham group, with 30min of treatment twice a day for 4 weeks. The primary outcome was the response rate at week 4, defined as the proportion of patients whose modified FDSD score was reduced ≥5 when compared with the baseline. Secondary outcomes included adequate relief rate and adverse events etc.
Results
A total of 300 patients were randomized to V10 (n=101), V25 (n=99), and sham group (n=100). After 4 weeks of treatment, V10 and V25 group had higher response rate (81.2% vs. 75.9% vs. 47%, both p<0.001) and adequate relief rate (85.1% vs. 80.8% vs. 67%, both p<0.05) compared with sham group. There was no significant difference between V10 and V25 in response rate and adequate relief rate (both p>0.05). The efficacy of taVNS (both 10Hz and 25Hz) lasted at week 8 and week 12 during follow-up period. Adverse events were all mild and comparable among the three groups (1-3%).
Conclusion
Our study firstly showed that 4-week taVNS (both 10Hz and 25Hz) was effective and safe for the treatment of adult FD. (clinicaltrials.gov number: NCT04668534)
... Our study explored potential beneficial effects using diverse patient response outcomes (20)(21)(22)(23)(24), including the validated daily symptoms diary, the LPDS, and a quality-of-life instrument, the NDI scale. The rationale to study potential benefits of CBD on FD with predominant sensory symptoms and normal baseline GE was based on the following: first, targeting (as an inverse agonist) of G protein-coupled receptors 3, 6, and 12 (7,8), a family of closely related orphan receptors that play important roles in many normal physiological functions and to be involved in a variety of pathological conditions such as GPR3 9 in neuropathic pain after peripheral nerve injury; second, plant cannabinoids, including CBD, dose dependently desensitize TRPV1, TRPV2, and TRPA1 in transfected HEK293 cells (10); third, targeting anti-inflammatory effects (11) that may lead to neuroprotection; and fourth, targeting 5-HT1A receptors (10) that may relieve experimental pain and modulate gastric accommodation (12). ...
Background:
Cannabidiol (CBD), a CBR2 agonist with limited psychic effects, antagonizes CB1/CB2 receptors. Allelic variation CNR1 (gene for CBR1) rs806378 and FAAH rs324420 were associated with altered gut motility and sensation. This study aimed to compare pharmacodynamics and clinical effects of 4-week treatment with pharmaceutical grade CBD vs. placebo and also to assess interactions of FAAH and CNR1 gene variants on effects of CBD in patients with functional dyspepsia (FD).
Methods:
We performed a randomized, double-blinded, placebo-controlled (1:1 ratio) study of CBD b.i.d. (20mg/kg/day according to FDA escalation guidance) in FD patients with non-delayed gastric emptying (GE) at baseline. Symptoms were assessed by validated daily symptom diary (0-4 scale for upper abdominal pain, nausea, bloating), weekly assessment of adequate relief, Leuven Postprandial Distress Scale (LPDS, 8 symptoms, adjectival scores rated 0-4 for severity), and quality of life [Short Form Nepean Dyspepsia Index (average of 10 dimensions each on 5-point scale)]. After 4-week treatment, all patients underwent measurements of GE of solids, gastric volumes, and Ensure® nutrient satiation test. Statistical analysis compared 2 treatments for all endpoints and effects of CBD in association with FAAH rs324420 and CNR1 rs806378.
Results:
CBD and placebo effects on physiological and patient response outcomes were not significantly different. There were borderline CBD treatment-by-genotype interactions: rs806378 CNR1 with LPDS (p=0.06), and GE solids (p=0.12).
Discussion:
Approved doses of CBD used off-label do not relieve FD with normal baseline GE solids or alter gastric motor functions and satiation. CBD treatment-by-gene interactions suggest potential benefit for postprandial distress with CNR1 rs806378 T allele.
... 5 Functional dyspepsia symptom diary (FDSD) is a newly symptom-focused PRO measure raised by the Patient-Reported Outcome Consortium's Functional Dyspepsia Working Group. 12 This simple score system consists of five items, including burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety. The content-valid measure of FDSD was developed according to FDA guidance recommendations. ...
... The primary outcome was the FDSD total symptom score (TSS). As reported previously, 12 FDSD consists of five cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and three supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). ...
... Mild, moderate, and severe FD was reported by 79 (18.5%), 238 (55.9%), and 109 (25.6%) of patients, respectively. FDSD was significantly different among three groups of patients (16 [2][3][4][5][6][7][8][9][10][11][12][13] for mild vs. 19 for moderate and 22 for severe, P < 0.001). Significant differences among patients with different severity were also revealed by the other five questionnaire scores (Figure 3). ...
Background:
Functional Dyspepsia Symptom Diary (FDSD) is a newly designed questionnaire of functional dyspepsia (FD). The relationships between FDSD and other FD-related questionnaires and patient-reported severity remain unclear.
Aims:
To investigate the correlations between FDSD and other questionnaires and determine the relationships between FDSD and FD severity.
Methods:
Consecutive outpatients with FD were prospectively enrolled in 4 tertiary hospitals. All patients were evaluated by 6 FD-related questionnaires, including FDSD, Dyspepsia Symptom Severity Index (DSSI), Gastrointestinal Symptom Rating Scale, Short-Form Nepean Dyspepsia Index and Hamilton Depression and Anxiety Scale (HAMD, HAMA). The severity of FD was also graded as mild, moderate and severe by patients themselves. Correlations between different scores were assessed by Spearman correlation coefficient (ρ), and risk factors for patient-reported severity were identified.
Results:
For 512 enrolled FD patients, the overall median FDSD score was 19 (2-42). FDSD was well correlated with DSSI (ρ=0.64) and fairly correlated with the other four scores (ρ=0.32-0.55) (all p<0.001). Mild, moderate, and severe FD were reported by 18.5%, 55.9% and 25.6% of patients respectively. There were seven factors associated with the severe FD, including education level, duration, and subtypes of FD, prior treatment, FDSD, HAMD and HAMA scores (all p<0.10). FDSD ≥20 (OR 3.3, 95% CI: 2.0-5.2, p<0.001) and HAMD ≥13 (OR 2.9, 95% CI: 1.8-4.6, p<0.001) were independently associated with patient-reported severe FD.
Conclusions:
This study firstly revealed that the newly developed FDSD correlated with other FD-related questionnaires. FDSD ≥20 and HAMD ≥13 were independently associated with severe FD reported by patients. (clinicaltrials.gov number: NCT04953975).
... Taylor et al. (17) designed a score to address the lack of symptom-focused measures in NOD patients. They interviewed 45 study participants to identify NOD symptoms and selected seven possible symptoms to construct the Functional Dyspepsia Symptom Diary (FDSD) score. ...
Background/aim:
The diagnostic accuracy of history-taking, clinical signs and tests and diagnostic scores (DSs) for patients with non-organic dyspepsia (NOD) have been rarely evaluated.
Patients and methods:
A cohort of 1333 patients presenting with acute abdominal pain (AAP) were studied, including 50 patients with confirmed NOD. The most significant diagnostic variables (in multivariate logistic regression analysis) were used to construct six different DS models and their diagnostic accuracy was compared with clinical symptoms and signs and tests. Meta-analytical techniques were used to detect the summary sensitivity (Se) and specificity (Sp) estimates for each data set (symptoms, signs and tests as well as DS models).
Results:
In hierarchical summary receiver operating characteristic (HSROC) analysis, the area under curve (AUC) values for i) symptoms ii) signs and tests iii) DS were as follows: i) AUC=0.608 [95% confidence interval (CI)=0.550-0.666]; ii) AUC=0.621 (95% CI=0.570-0.672) and iii) AUC=0.877 (95% CI=0.835-0.919). The differences between these AUC values (roccomp analysis) are as follows: between i) and ii) p=0.715; between i) and iii) p<0.0001; between ii) and iii) p<0.0001.
Conclusion:
The present study is the first to provide evidence that the DS could be used in diagnosis of NOD. The major advantage of our DS is that this model does not need radiology or endoscopy to reach high diagnostic accuracy.
... Patients completed an end-of-day diary using a smartphone app during a pretreatment period (2 weeks) and treatment period (12 weeks); the app was similar to the one used in the RCT on IBS. In the RCT on FD, however, the diary consisted of questions corresponding to the five core symptoms of FD: epigastric pain, epigastric burning, early satiety, postprandial fullness, and upper abdominal bloating [11]. In addition to these 5 questions, subjects were asked about adverse events and sporadic medication use. ...
Background
Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent adherence to a smartphone app used as symptom diary in a randomized clinical trial on irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time and provide useful information regarding possible symptom triggers, and they are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials.
Objective
This study aimed to compare the adherence rates of a smartphone-based end-of-day diary and ESM for symptom assessment in IBS and functional dyspepsia (FD).
Methods
Data from 4 separate studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+8-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+12-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Adherence rates were compared between these 2 symptom sampling methods.
Results
In total, 25 patients with IBS and 15 patients with FD were included. Overall adherence rates for the end-of-day diaries were significantly higher than those for ESM (IBS: 92.7% vs 69.8%, FD: 90.1% vs 61.4%, respectively).
Conclusions
This study demonstrates excellent adherence rates for smartphone app–based end-of-day diaries as used in 2 separate clinical trials. Overall adherence rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuous sampling during longer clinical trials.
... Indeed, at present there is not a single medication that is US Food and Drug Administration (FDA) approved for the management of functional dyspepsia. An important step in the development of FDA-approved therapies for functional dyspepsia is the identification of validated patient-reported outcome (PRO) measures, such as the Functional Dyspepsia Symptom Diary (FDSD), for use in future clinical trials[82,83]. ...
Functional dyspepsia is a common functional gastrointestinal (GI) disorder of gastroduodenal origin, diagnosed clinically in the presence of prototypical symptoms of epigastric pain and meal-related symptoms, and without structural explanation. The most recent diagnostic criteria provide for two functional dyspepsia subtypes, epigastric pain syndrome (EPS) and post-prandial distress syndrome (PDS) based on the predominant symptom pattern. The evaluation of dyspepsia should keep laboratory, imaging, and invasive testing to a minimum, as extensive or repetitive investigations are of rather low diagnostic yield in the absence of localizing symptoms or alarm features. Factors with etiopathologic relationships to functional dyspepsia include micro-inflammation, GI infections, abnormalities of gastroduodenal motility, visceral hypersensitivity, disturbances along the brain-gut axis, and psychological factors; all of these causative mechanisms have potential to partially explain symptoms in some functional dyspepsia patients, thus providing a rationale for the efficacy of a diversity of therapeutic approaches to functional dyspepsia. Management of dyspepsia symptoms relies upon both pharmacologic treatments and non-pharmacologic approaches, including psychological and complementary interventions. The evidence in support of established functional dyspepsia therapies is reviewed, and forms the basis for an effective functional dyspepsia treatment strategy emphasizing the patient’s current symptom severity, pattern, and impact on the function and quality of life of the individual.
... favour of a potential role for intestinal microbiota in the pathogenesis of FD are the occurrence of post-infectious FD and a single report of a response to treatment with the non-absorbable antibiotic rifax- imin.187,188More research on the pathophysiology of FD as well as interventional studies are needed to elucidate these aspects.Based on its prevalence, impact and associated unmet need, FD would be expected to represent an attractive drug development tar- get for pharmaceutical companies. However, the lack of an existing regulatory track (except for the approval of acotiamide in Japan), the focus on the closely related entity of (idiopathic) gastroparesis as well as the lack of validated patient-reported outcome (PRO) mea- sures have been major impediments to new drug development for FD.189The latter issue may be solved with development of PROs for FD both in Europe and in the USA.190,1915 | CONCLUSION SFunctional dyspepsia is a heterogeneous disorder in terms of symp- toms and pathophysiology, making the development of effective treat- ment options challenging. First-line therapy for FD consists of H Pylori eradication for infected patients, or acid suppressive drugs and proki- netic agents. ...
Background
Functional dyspepsia, consisting of epigastric pain syndrome and postprandial distress syndrome, is a prevalent functional gastrointestinal disorder. To date, only limited treatment options are available and conflicting results in terms of efficacy have been reported. Consequently, nonpharmacological treatment options are increasingly being explored for functional dyspepsia.
Aim
To provide an overview of current pharmacological and nonpharmacological treatment options for functional dyspepsia.
Methods
A literature search was conducted on Pubmed and other sources to identify relevant studies.
Results
Acid suppressive therapy reduced symptoms in 30%‐70% of the patients, with higher benefit in epigastric pain syndrome and superior effectiveness for proton pump inhibitors compared to H2‐antagonists. Prokinetic agents, primarily used to treat postprandial distress syndrome, showed variable efficiency: 59%‐81% responder rate for dopamine receptor antagonists, 32%‐91% for serotonin‐4‐receptor agonists and 31%‐80% for muscarinic receptor antagonists. H Pylori eradication, recommended in infected patients, was effective in 24%‐82%. Refractory symptoms are addressed with neuromodulators. However, their efficacy in functional dyspepsia remains incompletely elucidated, available data showing symptom reduction in 27%‐71% of the patients. Regarding herbal agents, peppermint oil reduced symptoms in 66%‐91%, rikkunshito in 29%‐34% and iberogast in 20%‐95%. Lastly, acupuncture, cognitive behavioural therapy and hypnotherapy may help to provide symptom control, but research on their efficacy remains sparse.
Conclusions
None of the available therapies is effective in the majority of patients without being associated with major side effects. Developing new treatment options is challenging due to the heterogeneity of functional dyspepsia, the lack of readily identified target mechanisms and the poor association between pathophysiological disturbances and symptoms.
... ,27 Moreover, bloating was considered the most important symptom for improvement with effective therapy during development of the "Functional Dyspepsia Symptom Diary".27 As the FDA states that the effect of treatment should be measured at the level of each symptom in order to ensure that treatment does not negatively affect symptoms, we suggest that a PROM should, as a minimum, evaluate the four FD core symptoms and the three frequently occurring additional symptoms.8 ...
... ,27 Moreover, bloating was considered the most important symptom for improvement with effective therapy during development of the "Functional Dyspepsia Symptom Diary".27 As the FDA states that the effect of treatment should be measured at the level of each symptom in order to ensure that treatment does not negatively affect symptoms, we suggest that a PROM should, as a minimum, evaluate the four FD core symptoms and the three frequently occurring additional symptoms.8 ...
... Food intake, medication use, and psychosocial factors were considered important triggers for generation and/or severity of gastrointestinal symptoms, which is in line with previous studies.26,[28][29][30] Repeated assessment of dyspeptic symptoms, together with symptom triggers, offers the potential to optimize and individualize treatment strategies, and this is a potential advantage of the novel ESM-based PROM, compared with the recently developed "Leuven Postprandial Distress Scale" (LPDS) and "Functional Dyspepsia Symptom Diary".27,31 Besides dyspeptic symptoms, lower gastrointestinal symptoms were studied, as evidence has been found for an increased preva-lence of IBS in patients with FD. 3,32 In our patient focus groups, 21% of patients had a comorbid diagnosis of IBS according to the Rome IV criteria, and this subgroup recommended inclusion of questions with regard to lower abdominal pain and defecation pattern. ...
Background
Patient‐reported outcome measures (PROMs) are used to assess symptoms in patients with functional dyspepsia (FD). Current end‐of‐day questionnaires have several limitations including sensitivity to recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments across momentary states in daily life and therefore less sensitive to these limitations. This study describes the development of a novel PROM based on ESM technology.
Methods
An initial draft of the PROM was developed based on literature. Focus group interviews with FD patients according to Rome IV criteria, and an expert meeting with international opinion leaders in the field of functional gastrointestinal disorders were conducted in order to select items for the PROM. Cognitive interviews were performed to evaluate patients’ understanding of the selected items and to create the definitive PROM.
Key results
A systematic literature search revealed 59 items across four domains (ie, physical status; mood and psychological factors; context and environment; and nutrition, medication, and substance use). After patient focus group interviews and an international expert meeting, the number of items was reduced to 33. Cognitive interviews resulted in some minor linguistic changes in order to improve patients’ understanding.
Conclusions and inferences
A novel digital ESM‐based PROM for real‐time symptom assessment in patients with functional dyspepsia was developed. This novel PROM has the potential to identify individual symptom patterns and specific triggers for dyspeptic symptoms, and optimize treatment strategies.
... The Leuven Postprandial Distress Scale for PDS was validated in 2016 [30]. The content validity and psychometric performance of a new PRO, the Functional Dyspepsia Symptom Diary, was recently reported [31]. Next validation steps, including test-retest reliability, sensitivity to change and determination of the minimal clinically important difference are needed to establish this diary as a PRO for FD studies. ...
Functional dyspepsia (FD) and gastroparesis are frequent causes of upper gastrointestinal symptoms such as postprandial fullness, early satiation, epigastric pain or burning, upper abdominal bloating, bothersome belching, nausea and vomiting. The underlying pathophysiological mechanisms are heterogeneous and involved mechanisms such as abnormal gastric motility (accommodation, emptying), visceral hypersensitivity, low grade mucosal inflammation and cellular changes in enteric nerves, muscle or interstitial cells of Cajal. Patient-reported outcomes for evaluating treatment efficacy in these conditions were recently developed and validated. Prokinetic agents, which enhance gastric motility, are used for treating both gastroparesis and FD. In FD, besides acid suppressive therapy and Helicobacter pylori eradication, neuromodulators and drugs that enhance gastric accommodation can be applied. In gastroparesis, anti-emetics may also provide symptom relief. Novel approaches under evaluation in these conditions are the fundus relaxing agents acotiamide and buspirone and the antidepressant mirtazapine in FD. For gastroparesis, recently studied agents include the prokinetic ghrelin agonist relamorelin, the prokinetic serotonergic agents velusetrag and prucalopride, the anti-emetic aprepitant and per-endoscopic pyloric myotomy procedures.
