European Journal of Cardiovascular Medicine

Functional dyspepsia (FD) is a common and chronic disorder of the upper gastrointestinal tract characterized by persistent or recurrent symptoms such as epigastric pain, burning, postprandial fullness, and early satiation in the absence of any structural or metabolic explanation on routine clinical evaluation and investigations. FD substantially impairs quality of life and poses a considerable burden on healthcare systems worldwide [1]. The International Rome IV diagnostic criteria, which are now widely accepted in both research and clinical practice, subdivide FD into two major symptom-based subtypes — postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS) — reflecting differences in symptom triggers and underlying pathophysiological mechanisms [2].

Epidemiological studies reveal that FD affects a significant proportion of adults globally, with a pooled prevalence estimated at approximately 8.4% according to recent meta-analyses encompassing diverse populations and diagnostic criteria [3]. Women tend to be affected more commonly than men, and symptom burden often decreases with advancing age [2][3]. While data specific to the Indian population are limited compared with Western cohorts, survey-based findings suggest that physicians in India frequently encounter FD in clinical practice, and that female predominance and prolonged symptom duration before consultation are commonly reported features [4]. Moreover, FD frequently overlaps with other functional gastrointestinal disorders such as irritable bowel syndrome, adding to diagnostic complexity [5].

The pathophysiology of FD is multifactorial and not yet fully elucidated. Proposed mechanisms include abnormal gastric motility, visceral hypersensitivity, impaired gastric accommodation, altered gut–brain interaction, microbiota changes, and psychosocial factors [1]. Among these, gastric motility dysfunction has been implicated particularly in PDS and overlapping symptom phenotypes, supporting a role for agents that enhance gastrointestinal motor activity [1][6].

Management strategies for FD aim to alleviate symptoms, improve quality of life, and target underlying mechanisms where possible. Lifestyle and dietary modifications, reassurance, and eradication of Helicobacter pylori when present serve as initial steps. Pharmacological therapy commonly includes acid suppression with proton pump inhibitors (PPIs), visceral analgesics, and prokinetic agents that enhance gastric emptying and improve antral contractility [7]. Prokinetics such as metoclopramide, domperidone, and cinitapride have been evaluated, but concerns regarding safety profiles and inconsistent efficacy limit their widespread use [8][9]. Itopride, a prokinetic with dual action as a dopamine D2 receptor antagonist and acetylcholinesterase inhibitor, has attracted clinician interest due to its favorable tolerability and potential symptomatic benefits in FD, especially for symptoms associated with impaired gastric motility [10][11]. Long-term follow-up data from recent multicenter trials indicate sustained symptom improvement and acceptable safety with itopride in FD patients, although results across studies remain heterogeneous [12][13]. Clinicians’ perceptions and prescribing patterns regarding itopride and other prokinetics vary, influenced by both the available evidence and practical experience, highlighting a need to document real-world opinions on their role in the management of FD within the Indian clinical context.

Survey-based investigations into clinician perspectives can provide valuable insights into the diagnostic approaches, subtype recognition, and therapeutic preferences for FD — particularly in populations where epidemiologic data are scarce. Such data can inform guideline adaptation, identify gaps in practice, and ultimately guide future research priorities in the management of FD in India.

This study was designed as a cross-sectional, questionnaire-based survey aimed at assessing clinicians’ understanding of functional dyspepsia (FD), its subtypes, and the perceived role of prokinetic agents—particularly itopride—in the management of FD within the Indian population. The study was conducted over a predefined study period among practicing clinicians involved in the diagnosis and management of patients with upper gastrointestinal symptoms, including gastroenterologists, general physicians, and internal medicine specialists across India.

A total sample size of 200 clinicians was considered adequate for the study to ensure sufficient representation of varied clinical practices and to allow meaningful descriptive analysis of responses. Participants were recruited using a convenience sampling method through direct contact, professional networks, and electronic dissemination of the survey link. Clinicians with at least one year of independent clinical practice and experience in managing patients with functional gastrointestinal disorders were included in the study. Clinicians unwilling to provide informed consent or those not involved in routine management of dyspeptic symptoms were excluded.

Data collection was performed using a structured, self-administered questionnaire developed after a review of relevant literature and existing guidelines on functional dyspepsia. The questionnaire comprised sections addressing demographic and professional characteristics of clinicians, awareness and understanding of FD and its Rome IV–based subtypes, commonly encountered symptom patterns in the Indian population, preferred diagnostic approaches, and therapeutic strategies employed in routine practice. A specific section focused on clinicians’ experiences with prokinetic agents, particularly itopride, including indications for use, perceived efficacy across FD subtypes, impact on symptom relief and patient satisfaction, and observed tolerability.

Prior to dissemination, the questionnaire was reviewed for content clarity and relevance by subject experts, and minor modifications were made to improve comprehension. The survey was distributed electronically, and responses were collected anonymously to ensure confidentiality and minimize response bias. Participation was voluntary, and electronic informed consent was obtained from all respondents before initiation of the survey.

Collected data were entered into a spreadsheet and analyzed using appropriate statistical software. Descriptive statistics were used to summarize clinician demographics and response patterns. Categorical variables were expressed as frequencies and percentages, while continuous variables, where applicable, were summarized as mean with standard deviation. Results were interpreted to identify prevailing trends in clinicians’ perceptions regarding FD subtypes and the role of itopride in symptom management.

The study was conducted in accordance with ethical principles outlined in the Declaration of Helsinki. Confidentiality of participants was strictly maintained, and no identifiable personal or institutional information was collected or disclosed at any stage of the study

Clinicians’ opinions regarding the burden, symptom profile, and chronicity of functional dyspepsia in Indian clinical practice are presented in Table 1. A substantial proportion of patients were perceived to suffer from prolonged dyspeptic symptoms, with 71.0% of clinicians reporting that 30–69% of their patients experienced FD symptoms for more than six months, while 20.0% indicated that over 70% of patients had persistent symptoms. Uncomfortable post-prandial fullness or inability to complete regular-sized meals for at least six months was commonly encountered, as 46.0% of clinicians observed this symptom in 30–49% of patients and 24.0% in 50–69% of patients. Epigastric pain or burning after meals lasting for six months or longer was also frequent, with 49.0% of clinicians reporting this symptom in 30–49% of patients and 23.0% in 50–69% of patients. Delay in seeking medical care was evident, as 62.0% of clinicians reported that patients suffered for more than six months before consultation, and 28.0% stated that patients waited for over one year. Additionally, bothersome post-prandial fullness or early satiation occurring three or more days per week was reported by 52.0% of clinicians in 30–49% of patients, whereas bothersome epigastric pain or burning occurring at least once weekly was noted by 47.0% of clinicians in 30–49% of patients, indicating a high symptom burden.

Clinicians’ perspectives on diagnostic practices for functional dyspepsia are summarized in Table 2. The majority of clinicians (78.0%) relied primarily on detailed clinical history for diagnosis, while 71.0% routinely applied Rome IV criteria. Empirical proton pump inhibitor trials were used by 37.0% of clinicians, and 41.0% recommended endoscopic evaluation when required to exclude organic disease. Regarding guideline adherence, 77.0% of clinicians followed the American College of Gastroenterology guidelines, while 15.0% preferred Asian guidelines. Only a small proportion used Canadian guidelines (2.0%) or other recommendations (6.0%).

Treatment practices for functional dyspepsia and its subtypes are detailed in Table 3. Proton pump inhibitors were prescribed by 60.0% of clinicians, while 56.0% reported using a combination of PPI and prokinetic therapy. Among prokinetic agents, itopride was the most frequently prescribed, used in 40.0% of patients overall, and was the preferred agent for post-prandial distress syndrome by 66.0% of clinicians. In epigastric pain syndrome with overlap features, 68.0% favored a combination of PPI and itopride. Other prokinetics such as domperidone (24.0%), acotiamide (18.5%), levosulpiride (15.0%), and cinitapride (14.5%) were used less frequently. The mean time to clinical response ranged from 4.6 to 5.6 weeks, with itopride demonstrating a relatively faster response (4.9 ± 2.2 weeks).

Clinicians’ experiences with itopride in managing bothersome post-prandial fullness and bloating are presented in Table 4. A considerable proportion of clinicians reported prescribing itopride to a large segment of patients, with 36.0% using it in 40–60% of patients and 23.0% in more than 60% of patients. In terms of effectiveness, 43.0% of clinicians observed symptom improvement in 40–60% of patients, while 33.0% reported effectiveness in more than 60% of patients, suggesting consistent real-world benefit.

Clinicians’ perspectives on the FD subtypes responsive to itopride and its advantages are outlined in Table 5. More than half of the clinicians (53.0%) believed that itopride was useful across all subtypes of functional dyspepsia, while 39.0% identified post-prandial distress syndrome as the most responsive subtype. The EPS–PDS overlap was considered responsive by 27.0%, whereas 16.0% felt it was useful mainly in epigastric pain syndrome. The most frequently cited advantage of itopride was the absence of extrapyramidal or cardiac side effects (41.0%), followed by high efficacy (36.0%), usefulness across FD subtypes (22.0%), and alignment with Rome IV–based management (19.0%).

Table 1: Clinicians’ opinions on FD in Indian clinical practice (n = 200)

Table 2: Clinicians’ perspectives on diagnosis of FD

Table 3: Clinicians’ practices for the management of FD and its subtypes

Table 4: Itopride in bothersome post-prandial fullness/bloating (n = 200)

Table 5: Clinicians’ perspectives on response with and advantages of itopride

In Indian clinical practice, FD is frequently managed with a combination of detailed clinical evaluation, guideline-based diagnostic criteria, and tailored pharmacotherapy. Prokinetic agents, especially itopride, remain integral to clinician therapeutic strategies, particularly for post-prandial symptoms, despite varying levels of evidence across agents. The heterogeneity of clinical responses and the modest strength of existing evidence underscore the need for future high-quality randomized trials focusing on symptom-specific outcomes and long-term benefits of prokinetic therapy in FD.

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