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

ObjectivesCurcumin 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. DesignPatients 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). ResultsA 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. ConclusionCurcumin and omeprazole have comparable efficacy for functional dyspepsia with no obvious synergistic effect. Key MessagesO_ST_ABSWhat is already knownC_ST_ABSO_LIDyspepsia is one of the most common disorders in which patients usually try behavioral and diet modifications, and over-the-counter drugs before seeing a physician. C_LIO_LIProton pump inhibitors have been established as an effective treatment for functional dyspepsia. C_LIO_LICurcumin, an active ingredient in turmeric, is currently used for the treatment of dyspepsia in countries in Southeast Asia. C_LIO_LIHowever, there is no clinical trial evidence to support the use of curcumin as a first-line treatment. C_LI What this study addsO_LIBased on this double-blind, placebo-controlled clinical trial, oral curcumin is safe and well tolerated. C_LIO_LIPatients with functional dyspepsia were treated with curcumin, curcumin plus omeprazole, and omeprazole, which showed a similar significant symptomatic improvement. C_LIO_LIThere was no synergistic effect detected between omeprazole and curcumin. C_LI How this study might affect research, practice, or policyO_LIThis study provides a possible additional drug option for patients with functional dyspepsia. C_LIO_LIMore clinical trials are required to assess long-term outcomes and adverse events. C_LI