MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

A new acupuncture study puzzles me a great deal. It is a “randomized, double-blind, placebo-controlled pilot trial” evaluating acupuncture for cancer-related fatigue (CRF) in lung cancer patients. Twenty-eight patients presenting with CRF were randomly assigned to active acupuncture or placebo acupuncture groups to receive acupoint stimulation at LI-4, Ren-6, St-36, KI-3, and Sp-6 twice weekly for 4 weeks, followed by 2 weeks of follow-up. The primary outcome measure was the change in intensity of CFR based on the Chinese version of the Brief Fatigue Inventory (BFI-C). The secondary endpoint was the Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS). Adverse events were monitored throughout the trial.

A significant reduction in the BFI-C score was observed at 2 weeks in the 14 participants who received active acupuncture compared with those receiving the placebo. At week 6, symptoms further improved. There were no significant differences in the incidence of adverse events of the two group.

The authors, researchers from Shanghai, concluded that fatigue is a common symptom experienced by lung cancer patients. Acupuncture may be a safe and feasible optional method for adjunctive treatment in cancer palliative care, and appropriately powered trials are warranted to evaluate the effects of acupuncture.

And why would this be puzzling?

There are several minor oddities here, I think:

  • The first sentence of the conclusion is not based on the data presented.
  • The notion that acupuncture ‘may be safe’ is not warranted from the study of 14 patients.
  • The authors call their trial a ‘pilot study’ in the abstract, but refer to it as an ‘efficacy study’ in the text of the article.

But let’s not be nit-picking; these are minor concerns compared to the fact that, even in the title of the paper, the authors call their trial ‘double-blind’.

How can an acupuncture-trial be double-blind?

The authors used the non-penetrating Park needle, developed by my team, as a placebo. We have shown that, indeed, patients can be properly blinded, i. e. they don’t know whether they receive real or placebo acupuncture. But the acupuncturist clearly cannot be blinded. So, the study is clearly NOT double-blind!

As though this were not puzzling enough, there is something even more odd here. In the methods section of the paper the authors explain that they used our placebo-needle (without referencing our research on the needle development) which is depicted below.

Park Sham Device Set

Then they state that “the device is placed on the skin. The needle is then gently tapped to insert approximately 5 mm, and the guide tube is then removed to allow sufficient exposure of the handle for needle manipulation.” No further explanations are offered thereafter as to the procedure used.

Removing the guide tube while using our device is only possible in the real acupuncture arm. In the placebo arm, the needle telescopes thus giving the impression it has penetrated the skin; but in fact it does not penetrate at all. If one would remove the guide tube, the non-penetrating placebo needle would simply fall off. This means that, by removing the guide tube for ease of manipulation, the researchers disclose to their patients that they are in the real acupuncture group. And this, in turn, means that the trial was not even single-blind. Patients would have seen whether they received real or placebo acupuncture.

It follows that all the outcomes noted in this trial are most likely due to patient and therapist expectations, i. e. they were caused by a placebo effect.

Now that we have solved this question, here is the next one: IS THIS A MISUNDERSTANDING, CLUMSINESS, STUPIDITY, SCIENTIFIC MISCONDUCT OR FRAUD?

8 Responses to Does this acupuncture study have a whiff of scientific misconduct? What do you think?

  • ‘fatigue is a common symptom experienced by lung cancer patients.’
    But what is the natural history untreated? If it was expected to resolve in say two months then there could be at the very best a short term advantage would there not? Or have I misunderstood?

  • Why even test this silly therapy? you may as well waste time and money testing “real” and “sham” fairy dust because there is the same amount of scientific plasibility for that.

  • I might add that some of the inconsistency might come from language or translation difficulties, but again, why keep trying to “prove” that needling the body at made up “points” has medical value? Let the Chinese carry on if they must, but who’s letting this junk into journals?

  • Call me a prejudiced, but I dismiss out of hand any study concerning acupuncture or other TCM modalities originating from China. I must have dug through hundreds of those ‘studies’, and the few that have no glaring flaws still lack credibility, not to mention the fact that results aren’t replicated. Ever.
    (The same goes for homeopathy ‘studies’ from India, or naturopathy ‘studies’ from the US, for that matter.)

    IS THIS A MISUNDERSTANDING, CLUMSINESS, STUPIDITY, SCIENTIFIC MISCONDUCT OR FRAUD?

    I’d say it’s the usual TCM propaganda in Mao’s finest tradition. So all of the above.

  • Two of the trial authors belong to the Dept of Integrative Oncology, Fudan University.

    However, all except one of the authors have a long history of acupuncture research, dating back as far as 1984 (Chen H), with most of the other authors having acupuncture studies dating to 2005/2006.

    Ning is a newby.

    The rest are seasoned deceivers.

    • I don’t believe they deliberately seek to mislead, instead they fail rule number one.

      Feynman’s rule number one is not to deceive the easiest person to deceive – yourself.

      These “researchers” are no such thing. They can only see what they believe to be unquestionably true.

      They are blinded by their belief.

      • perhaps – but they clearly used the placebo-needle wrongly.

        • Clearly. How could they fail to see it?

          Blindness to their profound bias, I believe. A bias which has taken deep root in China where “Traditional Chinese Medicine” is seen as a national treasure. I have mentioned before, that Xi Jinping has declared TCM to be fully the equal of “Western Medicine”. Certainly, that fact is likely to concentrate “researchers” minds in reaching “correct” conclusions if they do have any doubts.

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