You may remember my post entitled “How turn a negative trial into a positive one? Simple, just cheat!”
No?
Let me remind you by copying the relevant parts of my original post of 20/2/2018:
…The purpose of their study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.
The results showed that anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.
From this, the authors of the study concluded that sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy.
Well, isn’t this just great? Faced with a squarely negative result, one simply ignores it and draws a positive conclusion!
As we all know – and as trialists certainly must know – controlled trials are designed to compare the outcomes of two groups. Changes within one of the groups can be caused by several factors unrelated to the therapy and are therefore largely irrelevant. This means that “no significant difference between changes of Sipjeondaebo-tang group and placebo group” indicates that the herbal mixture had no effect. In turn this means that a conclusion stating that “sipjeondaebo-tang appears to have potential benefit for anorexia” is just fraudulent.
This level of scientific misconduct is remarkable, even for the notoriously poor Evid Based Complement Alternat Med...
END OF QUOTE
This article prompted me to do something I have only done once before: I filed an official complaint with the journal. I received a reply that they would look into it. Then there was silence; then came 2 or 3 emails that they are still considering my complaint. Yesterday, I finally received the following response:
Dear Dr. Ernst,
With reference to our correspondence below, thank you again for raising this matter, we appreciate your careful attention to the reporting of this article. The authors have apologized for the error and said they did not check the abstract carefully enough when revising the article. The board decided that this may be addressed by publishing a corrigendum; please find the notice attached to this email. Please let us know if you would like to be acknowledged in the notice for raising this issue, e.g. as follows: “This error in the reporting was brought to the attention of the journal by Prof. Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter.”
I look forward to hearing from you.
Kind regards…
And the attachment reads as follows:
Corrigendum to “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial”
Dear Dr. Ernst,
With reference to our correspondence below, thank you again for raising this matter, we appreciate your careful attention to the reporting of this article. The authors have apologized for the error and said they did not check the abstract carefully enough when revising the article. The board decided that this may be addressed by publishing a corrigendum; please find the notice attached to this email. Please let us know if you would like to be acknowledged in the notice for raising this issue, e.g. as follows: “This error in the reporting was brought to the attention of the journal by Prof. Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter.”
I look forward to hearing from you.
Kind regards…
Chunhoo Cheon,1 Jeong-Eun Yoo,2 Hwa-Seung Yoo,2 Chong-Kwan Cho,2 Sohyeon Kang,1 Mia Kim,3 Bo-Hyoung Jang,1 Yong-Cheol Shin,1 and Seong-Gyu Ko1
1Department of Preventive Medicine, Korean Medical College, Kyung Hee University, Seoul, Republic of Korea 2Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea 3Department of Cardiovascular and Neurologic Disease (Stroke Center), College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea
In the article titled “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial” [1], there was an error in the conclusion of the Abstract where the text reading “Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy” should be corrected to “In the present study, Sipjeondaebo-tang did not show a significant effect on anorexia in patients with cancer. Further large-scale studies which compensate for the limitations of this study are needed to assess the efficacy”.
References
1. Chunhoo Cheon, Jeong-Eun Yoo, Hwa-Seung Yoo, et al., “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial,” Evidence-Based Complementary and Alternative Medicine, vol. 2017, Article ID 8780325, 9 pages, 2017. doi:10.1155/2017/8780325
So, what should we make of all this?
On the one hand, it is laudable that the Journal does correct the mistake. Bravo!!!
On the other hand, I find it odd that only the authors seem to be found guilty of an ‘error’. Even if it was just a error – and I am happy to give them the benefit of the doubt – there are other parties involved. The reviewers have a responsibility and so does the editor! Should they not own up to it?
In the end, this sorry tale does not restore my confidence in this Journal, quite the opposite. In view of all this, I have to repeat what I stated in my previous post:
I strongly suggest that:
- The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
- The paper is withdrawn because it can only mislead vulnerable patients.
PS
Needless to say that my reply to the above-cited email was to uphold my complaint and urge the Journal to publish an adequate response that includes and explains the failures of the reviewers and the editor. So: watch this space!
19 Responses to How turn a negative trial into a positive one? Simple, just cheat! PART TWO OF A SORRY TALE
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” (…) Further large-scale studies which compensate for the limitations of this study are needed to assess the efficacy.”
Are they really? Why?
I guess that´s the conclusion that has to be expected from “scientists” who obviously do not have any skills in deductive reasoning.
The trouble is that once it’s out there any subsequent correction or modification will be ignored. The Truth About Cancer site and similar do this a lot, as you know.
It’s like the early, lying attacks on Jeremy Corbyn( whatever one’s personal opinions of him may be).
Cherry- picking, in other words.
One which gained some popularity at the time was that he said ‘What a tragedy it was that bin Laden had been shot and killed’.
Which he did in fact say.
That he ended by saying ‘instead of being brought to justice and put on trial for his crimes’ proved to be inconvenient, so was always missed off.
As a serial killer said in a book I’m reading, when questioned about exceeding the speed limit, ‘It’s only illegal if you get caught’.
Or, as the crook Nixon said, ‘If the President does it, it’s not illegal’.
Surely the journal’s title creates an obligation to respect the evidence? So the editor is responsible. It’s the old story, the peer reviewers for a quack journal and yet more quacks.
we shall see whether they have the honesty to admit and apologise for their ‘errors’;
I have now asked them to do so.
I am impressed that the journal was willing to publish a correction. I am not sure that this greatly increases my faith in other articles in that journal but the journal’s and the authors’ behaviour is quite commendable when we think of some “reputable” journals and authors that either have been dragged kicking and screaming to issue a correction or retraction or simply stonewall any criticism, while insisting that, just because half the results are nonsense, there is no reason to think the overall conclusions are not valid.
@jrkrideau:
you set the bar very low. There is absolutely no reason to be impressed. Being an author or reviewer for a number of peer-reviewed papers myself, issuing a correction (or retraction) of a paper is the very LEAST that the authors and the journal can and should do if they published erroneous (or in fraudulent cases even falsified) articles.
You are correct that some authors/journals are very hesitant or even reject to do so. However, the fact that some authors/journals behave even worse than those in this case does not justify any praise, since the authors, editors and reviewers have done a VERY POOR job in the first place.
Oh I agree that I am setting the bar very low, far too low. Unfortunately there seem to be a lot of journals and authors who cannot even get over it.
You are correct that “the authors, editors and reviewers have done a VERY POOR job in the first place”. My point is that they have, at least partially admitted it. I think they deserve a bit of credit for that.
Edzard
Interesting reading.
https://dictionary.cambridge.org/dictionary/english/it-takes-a-thief-to-catch-a-thief
It is indeed an interesting reading. Your assumption that Dr. Ernst is dishonest, if true, would require you to also be dishonest, to have been able to catch him.
On the other hand, your perverted logic really precludes dishonesty from the list of your qualities. Delusion, however, tops that list.
James
See below.
Perhaps alternative journals are allowed to have alternative results–unless challenged by nasty skeptics?
the journal sent me today this version of their correction and I have accepted it:
Corrigendum to “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, DoubleBlind, Placebo-Controlled Trial”
Chunhoo Cheon,1 Jeong-Eun Yoo,2 Hwa-Seung Yoo,2 Chong-Kwan Cho,2 Sohyeon Kang,1 Mia Kim,3 Bo-Hyoung Jang,1 Yong-Cheol Shin,1 and Seong-Gyu Ko1 1Department of Preventive Medicine, Korean Medical College, Kyung Hee University, Seoul, Republic of Korea 2Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, Republic of Korea 3Department of Cardiovascular and Neurologic Disease (Stroke Center), College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea
In the article titled “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial” [1], there was an error in the conclusion of the Abstract where the text reading “Sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy” should be corrected to “In the present study, Sipjeondaebo-tang did not show a significant effect on anorexia in patients with cancer. Further large-scale studies which compensate for the limitations of this study are needed to assess the efficacy”.
This error in the reporting was brought to the attention of the journal by Prof. Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter. The journal and the authors apologise for this misreporting of the conclusions.
References
1. Chunhoo Cheon, Jeong-Eun Yoo, Hwa-Seung Yoo, et al., “Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial,” Evidence-Based Complementary and Alternative Medicine, vol. 2017, Article ID 8780325, 9 pages, 2017. doi:10.1155/2017/8780325
If the study did NOT ‘show a significant effect on anorexia in patients with cancer’, what is the point of doing further large-scale studies?
I agree – however, they could argue that due to a type 2 error the study was false-negative.
James
“This subsequent study stated that “a review of the original case reports and case series papers described by Ernst found numerous errors or inconsistencies,” including changing the sex and age of patients, misrepresenting patients’ response to adverse events, and claiming that interventions were performed by chiropractors, when no chiropractor was even involved in the case.
“In 11 cases of the 21…that Ernst reported as [spinal manipulative therapy] administered by chiropractors, it is unlikely that the person was a qualified chiropractor,” the review found.
What is interesting here is that Edzard Ernst is no rookie in academic publishing. In fact, he is a retired professor and founder of two medical journals. What are the odds that a man with this level of experience could overlook so many errors in his own data?
The likelihood of Ernst accidentally allowing so many errors into his article is extremely small. It is far more likely that Ernst selected, prepared, and presented the data to make it fit a predetermined conclusion.”
So, Ernst’s article is either extremely poor science, or witheringly inept fraud. I’ll let the reader draw their own conclusion.
http://www.averyjenkins.com/blog/1941
so, please tell me how – even if I did got the sex and age of some patients wrong – these errors impact on the conclusion of the paper?
James
Read “Homeopathy: Meta-Analyses of Pooled Clinical Data”
Dr Hahn singles out Edzard for mis-representing data. Edzard makes no answer to this specific allegation.
oh dear!
we have dealt with Hahn and his silly accusations ad nauseam; please read up or shut up.
THEY JUST PUBLISHED THE CORRIGENDUM:
https://www.hindawi.com/journals/ecam/2018/6162106/