PT - JOURNAL ARTICLE AU - Kongkam, Pradermchai AU - Khongkha, Wichittra AU - Lopimpisuth, Chawin AU - Chumsri, Chitsanucha AU - Kosarussawadee, Prach AU - Phutrakool, Phanupong AU - Khamsai, Sittichai AU - Sawanyawisuth, Kittisak AU - Sura, Thanyachai AU - Phisalprapa, Pochamana AU - Buamahakul, Thanwa AU - Siwamogsatham, Sarawut AU - Angsusing, Jaenjira AU - Poonniam, Pratchayanan AU - Wanaratna, Kulthanit AU - Teerachaisakul, Monthaka AU - Pongpirul, Krit TI - Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial AID - 10.1136/bmjebm-2022-112231 DP - 2023 Dec 01 TA - BMJ Evidence-Based Medicine PG - 400--407 VI - 28 IP - 6 4099 - http://ebm.bmj.com/content/28/6/400.short 4100 - http://ebm.bmj.com/content/28/6/400.full SO - BMJ EBM2023 Dec 01; 28 AB - 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 No discernible differences were identified between curcumin and omeprazole in their efficacy for the functional treatment of dyspepsia, and no apparent synergistic effect was observed.Trial registration number TCTR20221208003.Data are available upon reasonable request. Data are available from the authors upon reasonable request.