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Original research
Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial
  1. Pradermchai Kongkam1,2,
  2. Wichittra Khongkha3,
  3. Chawin Lopimpisuth1,2,
  4. Chitsanucha Chumsri4,5,
  5. Prach Kosarussawadee1,2,
  6. Phanupong Phutrakool5,6,
  7. Sittichai Khamsai7,
  8. Kittisak Sawanyawisuth7,
  9. Thanyachai Sura8,
  10. Pochamana Phisalprapa9,
  11. Thanwa Buamahakul10,
  12. Sarawut Siwamogsatham1,2,
  13. Jaenjira Angsusing11,
  14. Pratchayanan Poonniam11,
  15. Kulthanit Wanaratna11,
  16. Monthaka Teerachaisakul11,
  17. Krit Pongpirul4,5,12,13
  1. 1Department of Internal Medicine, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand
  2. 2King Chulalongkorn Memorial Hospital, Bangkok, Thailand
  3. 3Chao Phraya Abhaibhubejhr Hospital, Prachin Buri, Thailand
  4. 4Department of Preventive and Social Medicine, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand
  5. 5Center of Excellence in Preventive & Integrative Medicine, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand
  6. 6Chula Data Management Centre, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand
  7. 7Khon Kaen University Faculty of Medicine, Khon Kaen, Thailand
  8. 8Ramathibodi Hospital, Mahidol University Faculty of Medicine, Bangkok, Thailand
  9. 9Siriraj Hospital, Mahidol University Faculty of Medicine, Bangkok, Thailand
  10. 10Ratchaburi Hospital, Ratchaburi, Thailand
  11. 11Department of Thai Traditional and Alternative Medicine, Royal Thai Government Ministry of Public Health, Bangkok, Thailand
  12. 12Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
  13. 13Department of Infection Biology & Microbiomes, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UK
  1. Correspondence to Associate Professor Krit Pongpirul, Center of Excellence in Preventive & Integrative Medicine and Department of Preventive and Social Medicine, Chulalongkorn University Faculty of Medicine, Bangkok 10330, Thailand; doctorkrit{at}gmail.com

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 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.

  • 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.

https://doi.org/10.1136/bmjebm-2022-112231

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    Data availability statement

    Data are available upon reasonable request. Data are available from the authors upon reasonable request.

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    Footnotes

    • PK and WK are joint first authors.

    • X @doctorkrit

    • PK and WK contributed equally.

    • Correction notice The journal received a rapid response that raised issues regarding the registration status of this trial and the methods. The journal investigated these issues with the collaboration of the authors, and has issued a correction covering the following aspects:a) BMJ EBM has a policy only to publish studies registered before recruiting the first participant. This study started recruitment in 2019 and was registered in 2022 due to an oversight of the authors. The authors declared this upon submission, and BMJ EBM failed to identify this issue. To review whether the methods were pre-specified, we reviewed the authors' study protocol from 2018 that was submitted for IRB ethics approval. BMJ was satisfied that the study was conducted and reported as planned and that no outcomes have been switched or omitted. The protocol has been uploaded as a supplementary file and a correction to the paper adds a statement that the trial was retrospectively registered.b) The CONSORT flow diagram of Figure 1 has been corrected due to an error in the number of people lost to follow-up in one of the treatment arms.c) The mention of 'equivalence' has been removed as the study was not designed as an equivalence trial. The wording related to 'comparable effects' has been amended.

    • 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.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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