Comparable Efficacy of Curcumin and Proton Pump Inhibitor for Functional Dyspepsia: A Randomized Double-blind Controlled Trial

Objectives Curcumin has been claimed to have gastrointestinal benefits, including dyspepsia, a common disorder that could be managed in a primary care setting with behavioral and dietary modifications as well as over-the-counter medications. This study aimed to compare the efficacy of curcumin versus omeprazole in improving patient-reported outcomes. Design Patients with functional dyspepsia were randomized to curcumin alone (C), omeprazole alone (O), or curcumin plus omeprazole (C+O). Patients in the combination group received 2 capsules of 250 mg curcumin 4 times daily and 1 capsule of 20 mg omeprazole once daily for 28 days. The primary outcomes were functional dyspepsia symptoms on days 28 and 56 assessed using the Severity of Dyspepsia Assessment (SODA) scores. Secondary outcomes were the occurrence of adverse events (AEs) and serious adverse events (SAEs). Results A total of 206 enrolled patients were randomly assigned to the three groups, of which 151 completed the study. Demographic data (age 49.7±11.9 years; female 73.4%), clinical characteristics, and baseline dyspepsia scores were comparable between the three groups. SODA scores in each group showed significant improvement on day 28 and day 56 in the pain, non-pain, and satisfaction categories. No significant differences were observed among the three groups and no serious adverse events occurred. Conclusion Curcumin and omeprazole have comparable efficacy for functional dyspepsia with no obvious synergistic effect. What is already known What this study adds How this study might affect research, practice, or policy ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial Thai Clinical Trial Registration TCTR20221208003 ### Funding Statement This study received financial support from the Department of Thai Traditional and Alternative Medicine, Ministry of Public Health, Nonthaburi, Thailand. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Ethics Committee for Research in Human Subjects in the Fields of Thai Traditional and Alternative Medicine (TAMEC No. 11-2561). Participants provided their written consent to participate in the study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. * AE : Adverse Events C : Curcumin C+O : Curcumin+Omeprazole EPS : Epigastric Pain Syndrome O : Omeprazole PDS : Postprandial Distress Syndrome PPIs : Proton Pump Inhibitors SAE : Serious Adverse Events SF-LDQ : Short-Form Leeds Dyspepsia Questionnaire SODA : Severity of Dyspepsia Assessment (SODA)