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- Published on: 22 August 2024
- Published on: 22 August 2024
- Published on: 10 January 2024
- Published on: 22 August 2024Multiple problems with reporting and interpretation of the results
Dear Editorial Office,
I want to express my concern regarding “Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial” by Kongkam et al(1). It was published against the journal’s editorial policy and has serious issues with reporting and interpretation of results.
The article shouldn’t have been published in the first place. It lacks prospective registration, which directly contradicts the BMJ Evidence-based medicine editorial policy stating that a prospective registration is mandatory for any clinical trials(2). The Thai Clinical Trials Registry(3) registration TCTR20221208003 is retrospective which is clearly stated in the registry. The registration was submitted on 07 December 2022, just before a preprint was posted on medRxiv on 09 December 2022, while the study was completed on 30 April 2020.
On top of that, there are serious issues with the reporting and interpretation of results.
According to the authors an equivalence design was used with the equivalence margin of 2 points in the SODA score. Nine comparisons of SODA scores in the curcumin plus omeprazole (C+O), curcumin only (C), and omeprazole only (O) groups were reported. For three of those confidence intervals include equivalence margin. The only available interpretation here is that the trial failed to demonstrate equivalence. To demonstrate equivalence the confidence intervals should be between the two equivalence margins rath...
Show MoreConflict of Interest:
None declared. - Published on: 22 August 2024Controlled but not placebo controlled
It is misleading (as stated in “what this study adds”) to described this trial as placebo controlled. Although dummy capsules were used to blind participants to which combination of curcumin or omeprazole they were receiving, no group received placebo only. One interpretation of the findings therefore remains that they are due to a placebo effect. It is unfortunate that this misrepresentation of the study design has already been picked up by a UK National newspaper (Guardian 12 September)
Conflict of Interest:
None declared. - Published on: 10 January 2024Inconsistencies in "Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial".
Dear Editor,
With great interest I read the original research article “Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial” by Kongkam et al. While the authors suggest that the study demonstrates that the efficacy of curcumin for functional dyspepsia is comparable to that of omeprazole, I want to point out some deficiencies and discrepancies of the study reporting that cast doubt on this conclusion.
Firstly, it is not clear what hypothesis was tested and what specific study results the conclusion is based on. The main outcomes are vaguely specified as functional dyspepsia symptoms. As the equivalence design is mentioned, the reference to improvement of 2 points in the SODA score between the treatment group should probably be interpreted as the equivalence margin set for the study. The results of nine pairwise comparisons are provided in Table 3. For three of them 95% confidence intervals include the equivalence margin, thus clearly demonstrating non-equivalency. For example, for pain intensity in curcumin only vs omeprazole only arms the 95% CI is −1.16 (−2.95 to 0.64), which demonstrates that curcumin is not non-inferior to omeprazole.
To add to the issue of unclear study question and selective post hoc interpretation of outcomes, it should be mentioned that the study was not registered prospectively. The TCTR registration (TCTR20221208003) is post factum. Also the authors do not properly explain...
Show MoreConflict of Interest:
None declared.