Validation of the Leuven Postprandial Distress Scale, a questionnaire for symptom assessment in the functional dyspepsia/postprandial distress syndrome

Background Acotiamide, a prokinetic agent was shown to be efficacious in the treatment of functional dyspepsia (FD). The exact mechanism of action is incompletely elucidated. Methods This randomized, placebo‐controlled, cross‐over study aimed to examine the effect of acotiamide on gastric motility, measured as intragastric pressure, gastric emptying (GE) rate and gastrointestinal (GI) symptom perception in healthy volunteers (HVs). Participants were treated with acotiamide (100 mg tid) and placebo for 3 weeks, separated by a 1‐week washout period. A daily symptom diary was collected during both treatments. At the end of each treatment period, GE rate and gastric motility were assessed with a 13C‐octanoic acid breath test and high‐resolution manometry during nutrient infusion, respectively. GI symptom levels were scored during high‐resolution manometry. Data were analyzed using mixed models. The study was registered as NCT03402984. Key Results Twenty HVs (10 female, 25 ± 4.1 years, 22.58 ± 2.73 kg/m2) participated in the study. There was no difference in GE half time between both treatments (P = 0.92). Acotiamide had no effect on fundic pressures before and after nutrient infusion (P = 0.91). However, postprandial antral pressures remained significantly lower compared to placebo (P = 0.015). There was no significant difference in hunger, satiation and GI symptoms scores assessed during IGP measurement and by the daily diary (P > 0.12 for all). Conclusion Acotiamide is associated with lower antral pressures after nutrient intake, whereas it has no effect on fundic pressures, GE rate and symptom perceptions in HVs. Studies in FD need to elucidate whether lower antral pressures induced by acotiamide underlie postprandial symptom improvement in FD.

Section: Methodsmentioning

confidence: 99%

Acotiamide affects antral motility, but has no effect on fundic motility, gastric emptying or symptom perception in healthy participants

Masuy

Tack

Verbeke

et al. 2019

“…20 It comprised eight symptoms with verbal descriptors ranging from 1 (absent) to 5 (very serious) accompanied by "smiley faces". This diary is a reliable patient-reported outcome instrument that assesses functional dyspepsia symptoms.…”

Section: Questionnairesmentioning

confidence: 99%

“…20 Additionally, each study visit, the following questionnaires on gastrointestinal symptoms and psychosocial state were completed: 20 Additionally, each study visit, the following questionnaires on gastrointestinal symptoms and psychosocial state were completed: …”

Section: Questionnairesmentioning

confidence: 99%

The effect of rikkunshito on gastrointestinal symptoms and gastric motor function: The first study in a Belgian functional dyspepsia population

Masuy

Carbone²,

Holvoet³

et al. 2019

Background: Rikkunshito, a traditional Kampo medicine, has shown efficacy to treat functional dyspepsia (FD) in controlled trials in Japan. Its putative benefit for European patients and mechanism of action has not been established.Methods: This study examined the effect of rikkunshito on gastric motility and GI symptom perception in FD-PDS patients in a randomized, placebo-controlled, crossover study. After a 2-week run-in period, patients received rikkunshito or matching placebo (2.5 g t.i.d.) for 4 weeks, separated by a 4-week washout period. Symptoms were assessed by the Leuven Postprandial Distress Scale (LPDS) diary throughout the study. At baseline and after both treatment arms, intragastric pressure (IGP) was measured to evaluate gastric accommodation and gastric motility. Simultaneously, GI symptoms were scored on a 100 mm visual analogue scale. Validated symptom questionnaires (PAGI-SYM, VSI, DSS, and PHQ) were completed each study visit.Key Results: Twenty-three patients completed the study (33 ± 14 years, 22.7 ± 3.22 kg/m 2 ). Intragastric pressure was numerically, but not significantly, lower after rikkunshito compared with baseline and placebo (P = .14). No differences were found in gastric accommodation, nutrient volume tolerance, and symptoms assessed during IGP measurements. Early satiation and postprandial fullness (daily diary) decreased after rikkunshito compared with baseline (P < .041 for both). Placebo also improved most other symptoms assessed. No significant changes in VSI scores occurred. No adverse reactions occurred. Conclusions:Rikkunshito did not alter gastric motility. Treatment with rikkunshito improved upper GI symptoms in FD patients but similarly high placebo effects were observed using the LPDS diary, PAGI-SYM, SF-NDI, and DSS scores. Rikkunshito was safe and well-tolerated. K E Y W O R D Sfunctional dyspepsia, gastrointestinal symptoms, intragastric pressure, rikkunshito 2 of 11 | MASUY et Al. | INTRODUC TI ONFunctional dyspepsia (FD) is, with its prevalence of 5%-20% worldwide, one of the most common functional gastrointestinal disorders for which patients seek medical care. 1 FD is defined as the presence of recurrent or chronic symptoms thought to originate from the gastroduodenal region, in the absence of any structural abnormalities found during routine diagnostic procedures. According to the Rome III criteria, FD can be subdivided into two subgroups based on the most prominent symptoms. One subgroup is referred to as postprandial distress syndrome (PDS), characterized by meal-related symptoms. Cardinal PDS symptoms are postprandial fullness and early satiation. The second subgroup is the epigastric pain syndrome (EPS) subgroup, defined by meal-unrelated symptoms, including epigastric pain and epigastric burning. 2,3 The recently renewed Rome IV criteria decreased the overlap between both subgroups by considering epigastric pain manifesting after meal intake as belonging to PDS. 2,4Although the underlying pathophysiology of FD remains unclear, different pathophysiological...

“…15 The weekly score of each symptom was calculated by taking the average of each 7-day period. The weekly change in each individual symptom score was summarized.…”

Section: Efficacy Outcomesmentioning

confidence: 99%

Long‐term safety and efficacy of acotiamide in functional dyspepsia (postprandial distress syndrome)—results from the European phase 3 open‐label safety trial

Tack

Pokrotnieks

Urbonas

et al. 2018

Self Cite

Backgrounds Acotiamide is a novel acetylcholinesterase inhibitor for treatment of postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). This European phase 3 open‐label safety trial has been conducted to evaluate the long‐term safety of acotiamide and explore the efficacy of acotiamide on PDS symptoms using the validated LPDS, quality of life using SF‐36 and SF‐NDI, and work productivity using WPAI. Methods FD‐PDS patients (defined by ROME III criteria) aged ≥18 years with active PDS symptoms and without predominant overlapping symptoms of epigastric pain syndrome and related disorders were enrolled to receive 100 mg acotiamide three times daily for 1 year. Patients' safety profile and efficacy of acotiamide were monitored. Key Results The majority of patients (81.6%) maintained exposure to acotiamide for >50 weeks, with a mean duration of 320.3 days. No specific clinically significant safety concerns have been shown, with no deaths, treatment‐related severe/serious adverse events, or any clinically significant laboratory test results. Although being an open‐label trial, acotiamide showed a change in severity larger than the minimum clinically important difference at weeks 1 and 2 for postprandial fullness and early satiation (meal‐related symptoms), and showed improvement of quality of life and work productivity from the first measurement (at week 12) up to 1 year. Conclusions & Inferences The long‐term safety of acotiamide treatment was confirmed. A clinically important change for PDS symptoms, QoL, and work productivity was suggested; however a controlled trial is required to confirm this hypothetic efficacy of acotiamide. (NCT01973790).