MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Sipjeondaebo-tang is an East Asian herbal supplement containing Angelica root (Angelicae Gigantis Radix), the rhizome of Cnidium officinale Makino (Cnidii Rhizoma), Radix Paeoniae, Rehmannia glutinosa root (Rehmanniae Radix Preparata), Ginseng root (Ginseng Radix Alba), Atractylodes lancea root (Atractylodis Rhizoma Alba), the dried sclerotia of Poria cocos (Poria cocos Sclerotium), Licorice root (Glycyrrhizae Radix), Astragalus root (Astragali Radix), and the dried bark of Cinnamomum verum (Cinnamomi Cortex).

But does this herbal mixture actually work? Korean researchers wanted to find out.

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 

I strongly suggest that:

  1. The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
  2. The paper is withdrawn because it can only mislead vulnerable patients.

11 Responses to How turn a negative trial into a positive one? Simple, just cheat!

  • Might be worth writing to the editor requesting that this misleading paper is retracted. Though I note that the ‘journal’ (or ‘rag’ as Edzard appropriately refers to it) – namely “Evidence-based complementary and alternative medicine” – is an uncritical, pro-CAM mouthpiece, so it would be doubtful that the editor would do the right thing. But worth asking, if only to record the reaction.

  • Great! Will be interesting to learn the response…

    • today I received this email from the publisher of the paper:
      Thank you for raising this issue with this article’s conclusions, we
      appreciate you contacting us about this. We follow the guidelines of
      the Committee on Publication Ethics (COPE), which recommend retraction
      in the case of “clear evidence that the findings are unreliable,
      either as a result of misconduct (e.g. data fabri- cation) or honest
      error (e.g. miscalculation or experimental error)” (please see
      https://publicationethics.org/files/retraction%20guidelines_0.pdf); we
      will consult our board about what action we may need to take in
      response to your claim.

      Please let us know if you have any further comments about the conduct
      or reporting of this research.

  • I’ve long thought there are three summary explanations for error:
    1. Ignorance – not knowing
    2. Incompetence – not caring
    3. Intent
    When seeing 1 and 2 survive without efforts to repair the error my distrust grows: exponentially with repetition.
    When I can see no explanation other than 3, I’m bemused that prosecutions don’t follow.
    How many deaths or prolonged unnecessary agonies must patients suffer before global legal consequences arrive on the bank accounts and liberties of charlatans?

  • Well — this was clearly a non-inferiority trial — and the herbal supplement was found to be non-inferior to placebo. Since the placebo effect is usually beneficial I guess they feel they can claim beneficence for their brew. Perhaps they should follow up with a superiority trial comparing it to a nocebo – like “you can take our brew or you will die!”

    Since the publication of Ioannidis’s PLOS article in 2005 that lamented that most published research is false — we have seen the exponential rise of predatory journals and rejection of scientific values (especially here in the US) — the topic needs to be updated to “most published research is crap”.

    I just discovered your website — great!! I am glad you have the energy for this. Keep it up please!

  • I just skimmed through the text and found that two secondary measures of efficacy used were the blood deficiency scale and the qi deficiency scale. The discussion section of the full text is relatively short and particularly interesting, as it explains what is going on in the minds of the researchers with stunning accuracy! Whoever wants a breathtaking research experience, I urge them to take a few minutes to read it.

    This is research at its absolutely worst! There is no hope for this journal, no hope at all…

    • I also like this:
      “This research was supported by the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (Grant no. HI12C1889).”
      There seems to be little hope too for the official funders of this trial.

    • @James

      Thanks for the link.

      Qi deficiency leads to decreased visceral functions and lowered body resistance and blood deficiency is any pathological change characterized by deficiency of blood which fails to nourish organs, tissues, and meridians/channels.

      Indeed. Say no more.

  • I’m surprised all that smelly stuff didn’t make those poor people throw up.

    I wish these guys would quit picking on cancer patients. Those people have enough problems already. I’d feel better if they stuck to people who think they have qi deficiencies.

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