Article Text
Abstract
Objective To compare the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
Design Randomised, double blind controlled trial, with central randomisation.
Setting Thai traditional medicine hospital, district hospital, and university hospitals in Thailand.
Participants Participants with a diagnosis of functional dyspepsia.
Interventions The interventions were curcumin alone (C), omeprazole alone (O), or curcumin plus omeprazole (C+O). Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measures Functional dyspepsia symptoms on days 28 and 56 were assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
Results 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
Conclusion Curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
Trial registration number TCTR20221208003.
- general practice
- digestive system disease
- integrative medicine
Data availability statement
Data are available upon reasonable request. Data are available from the authors upon reasonable request.
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Data availability statement
Data are available upon reasonable request. Data are available from the authors upon reasonable request.
Footnotes
PK and WK are joint first authors.
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PK and WK contributed equally.
Contributors PKon: data curation, writing original draft, review and editing. WK: data curation, writing original draft, review and editing. CL: writing original draft, review and editing. CC: writing original draft, review and editing. PKos: data curation, review and editing. PPhu: data curation, review and editing. SK: data curation, review and editing. KS: data curation, review and editing. TS: data curation, review and editing. PPhi: data curation, review and editing. TB: data curation, review and editing. SS: data curation, review and editing. JA: administration, data curation, review and editing. PPo: administration, data curation, review and editing. KW: supervision, data curation, review and editing. MT: supervision, funding, data curation, review and editing. KP: study design, data curation, formal analysis, writing original draft, review and editing. KP: guarantor.
Funding This study received financial support from the Thai Traditional and Alternative Medicine Fund (Grant No 3-2561).
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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