MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Shiatsu is one of those alternative therapies where there is almost no research. Therefore, every new study is of interest, and I was delighted to find this new trial.

Italian researchers tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive one of the following treatments:

  1. shiatsu plus amitriptyline,
  2. shiatsu alone,
  3. amitriptyline alone

The treatment period lasted 3 months and the primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month.

After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline.

The results show that all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers and there was no between-group difference in the primary endpoint. Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month. Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment.

The authors concluded that shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study.

Yes, I would advocate great caution indeed!

The results could easily be said to demonstrate that shiatsu is NOT effective. There is NO difference between the groups when looking at the primary endpoint. This plus the lack of a placebo-group renders the findings uninterpretable:

  • If we take the comparison 2 versus 3, this might indicate efficacy of shiatsu.
  • If we take the comparison 1 versus 3, it would indicate the opposite.
  • If we finally take the comparison 1 versus 2, it would suggest that the drug was ineffective.

So, we can take our pick!

Moreover, I do object to the authors’ conclusion that “shiatsu is a safe”. For such a statement, we would need sample sizes that are about two dimensions greater that those of this study.

So, what might be an acceptable conclusion from this trial? I see only one that is in accordance with the design and the results of this study:

 

POORLY DESIGNED RESEARCH CANNOT LEAD TO ANY CONCLUSIONS ABOUT THERAPEUTIC EFFICACY OR SAFETY. IT IS A WASTE OF RESOURCES AND A VIOLATION OF RESEARCH ETHICAL.

27 Responses to Shiatsu: fatally flawed research is an unethical waste of resources

  • I am only a little Teapot and technical-sounding words confuse me, but if I get this right: the study used a tricyclical anti-depressive drug off-label, not just for migraine (which it is sometimes used for), but any kind of primary headache?

    I find your conclusion to be remarkably generous. These people clearly think Ethics is a place near Suthics (old joke, I know) and I would describe the research as fraudulent.

  • Any ethical editor would reject the study and refuse to allow its publication.

    • It was a pilot study. An ethical editor would’ve highlighted its pitfalls, rather than refusing to publish it — in my opinion.

  • Definitely shouldn’t have received ethical approval. Group 2 should heave read “shiatsu plus amytryptyline placebo”. Group 3 should have read “amytryptyline plus shiatsu placebo”. (A separate placebo control was unnecessary.)

    Of course, a shiatsu placebo might be problematic, but it should be possible either to restrict the underlying shiatsu philosophy tested to the one that favours pressing on acupuncture points or the one that defines “energy pathways” (WTHTM) for flow of “qi” other than acupuncture points. Or, better still, shiatsu exponents could just accept they’re glorified masseurs and not become involved in silly shambolic clinical trials like this one.

  • Let’s not these the baby out with the bath water here. Many so called drug-medical trials also suffer from similar issues why not ban all medical trials? No wait they can and do have value if repeated and modified. Let’s try this one again with better parameters rather than sweeping statements. It’s clear there was a benefit to people who had shiatsu in terms of reduction in medications isn’t that something worth investigating? Why are doctors so scared to allow people to discover ways to maintain it balance their own health?
    When was the last time a “western” medical student or doctor was asked to consider how much of their interaction was placebo? My guess is not often try reading the work of Kaptchuk on this area very interesting, research on is branded placebo being better than unbranded real drugs etc,he argues that western doctors don’t do this often enough whilst they insist other therapies have a different standard. QED I’d say having read this article

    • ” Many so called drug-medical trials also suffer from similar issues”
      SHOW ME ONE DRUG THAT IS BACKED BY EVIDENCE AS POOR AS SHIATSU – JUST ONE.
      ” It’s clear there was a benefit to people who had shiatsu in terms of reduction in medications ”
      IS IT? FROM WHAT DO YOU CONCLUDE THAT?
      “Why are doctors so scared to allow people to discover ways to maintain it balance their own health?”
      WHAT MAKES YOU THINK ANYONE IS SCARED?
      “When was the last time a “western” medical student or doctor was asked to consider how much of their interaction was placebo?”
      ABOUT 5 MILLISECONDS AGO.
      “My guess is not often try reading the work of Kaptkuch…”
      PLEASE DON’T MISSPELL THE NAME OF MY FRIEND TED.

      • This website is a joke. Let’s just bag the hell out of anything that works. Shiatsu is safe, Shiatsu reduces severity of symptoms, Shiatsu reduces the need for medications. The limited studies available all say these same benefits. Do your research. Still though nothing will ever be good enough for people who are anti everything.

        • “Congratulations jack of all trades master of none.”
          I am ready to believe you… provided you show me the evidence for your claims.
          ” nothing will ever be good enough for people who are anti everything”
          we are not anti anything, we are pro evidence!

          • Whenever there is positive promising evidence, usually it it is quickly followed up by… But more research is required… And then nothing is heard again

            This study concludes Shiatsu to be safe and that the adverse side effects were attributable to the drug takers. What more do you want. You and your readers are just brainwashed.

          • I asked you for evidence. do I conclude from your remark that you have none?

          • Pro evidence: which science calculations you referring to. The one which adds 2+2 together to equal four or the one which adds 2+2 together to arrive at twenty two.

            Caution:Most scientific reports contain scam ware everyone knows that. These facts are broadcasted on a weekly basis by TV and all forms of media.

            Only scientists believe everything they read!

          • “Most scientific reports contain scam ware everyone knows that”
            please, tell us more.
            “Only scientists believe everything they read!”
            you are truly priceless – but you need to change your medication, I think.

        • @groupkyu

          Which studies?

        • Totally agree. The only thing fatally flawed here is this dismissive website, the authors views and opinions and the blind obedience of his narrow minded followers. To even suggest that you are an expert in complementary medicine when all you do is distract people away from the real benefits to be had is shameful to say the least.

          After reading through the nasty comments and antagonist replies left by the author it’s kind of easy to spot the real flaws that are going on here. It’s pretty much agree with what I say or experience my wrath. Yeah right

          • “… it’s kind of easy to spot the real flaws that are going on here…”
            PLEASE NAME THEM!

          • @tenquim

            “… the blind obedience of his narrow minded followers.”

            Please see this comment I just posted on another thread. Please don’t add stupid conspiracy theories to your blind support of Big Snakeoil.

          • how come you and groupkyu use the same server?
            are you the same courageous person hiding behind a pseudonym?

    • “Let’s try this one again with better parameters rather than sweeping statements.” But we’ve now learned how to do clinical trials properly, thanks to the many critical efforts of experts over the past 20 years. So why is anyone allowed to set up a clinical trial (even a pilot trial) that’s doomed to be judged of inadequate quality and almost certain to produce only equivocal results?

      “It’s clear there was a benefit to people who had shiatsu in terms of reduction in medications isn’t that something worth investigating?” No, it’s far from clear. You obviously don’t understand things like prior probability and statistical error. The p value for medication reduction was only <0.05, among a slew of other statistical tests. With group sizes of 11–13 the study provides zero information worthy of further investigation.

      "Why are doctors so scared to allow people to discover ways to maintain it balance their own health?" They're not scared, just realistic. They don't want to work like conjurors, fooling their patients with tricks they know are only placebo effects: besides they can't predict which patients will benefit from glorified TLC.

      "…he argues that western doctors don’t do this often enough whilst they insist other therapies have a different standard." He's mistaken. You need to see the enthusiasm with which doctors involved in clinical research tear into published clinical trials at professional meetings. They often do such effective demolition jobs they can get a publication out of their critiques.

      I don't doubt your sincerity, Ms Craig, but you need to discover the ways in which the scientific approach can reduce the probability of your fooling yourself.

    • Kaptchuck wrote a book-long sweeping statement.

      “The Web That Has No Weaver”.

    • Anyone who uses Shiatsu on a regular basis knows the value and benefits of this therapy.

      • what would be nice is EVIDENCE

          • oh dear!!!

          • Oh dear? Since running into your blog a few years ago, I’ve been asking around. I have yet to find anyone that chooses a therapy based on evidence from studies – modern, traditional, ‘alternative’, new age, blah blah blah. And that includes MDs who practice EBM.

            I’ve run into a bunch who will avoid the modern medicine system if they can, due to either lack of money, previous bad experience, “don’t like hospitals”, “don’t like being poked and prodded”, “don’t have time”. But I have yet to find anyone who would forgo modern conventional medicine for a serious illness. There’s probably someone, somewhere – but none of the hundreds of people I’ve asked, including the “I don’t like/trust doctors” crowd.

            Some have taken up yoga or running because “studies show…”. Some have tried diet changes, supplements, etc because “studies show…” – but it’s all over the counter stuff. And has no effect on forgoing modern medicine for a serious illness.

            So who would benefit from evidence for shiatsu?

          • if nobody else [as you suggest – but I disagree], for those who need to decide whether 1) it is worth paying for it via the public purse, it is worth continuing research into it, 3) it makes sense recommending it to patients, for instance.

          • 1. In the US, it’s not.
            2. no
            3. If all you know about shiatsu is study results, don’t recommend it. Stick with “I don’t know enough about it.”.

            There seems to be a lot of “I don’t need to know about x to know that it is effective/ineffective” on this site. Which is a load of crap. One example (out of many in the posts and comments) – in a previous post about massage & fibromyalgia, you wrote:

            “Therefore the conclusion for those who suffer from FM might well be that massage therapy is worth a try.” (http://edzardernst.com/2014/03/is-massage-therapy-effective-for-fibromyalgia/)

            Basing your conclusion on the study you cite is irresponsible. FM requires specific types of bodywork – we know this from experience, feedback from clients, and sharing information between practitioners. A generic recommendation of massage for FM can do more harm than good. Massage practitioners with FM clients know this – practitioners without that experience might not. FM patients may not (for many reasons) disclose to a massage practitioner the FM diagnosis. Their doc may have recommended massage, and in the patient’s mind it’s an informed recommendation. It’s not.

            Stick with “I don’t know enough about it.”. There’s nothing wrong with that.

          • “[jm] Since running into your blog a few years ago …”

            I think that “Since spewing into your blog a few years ago …” would be far more accurate — based on your trail of solid evidence — than is “Since running into your blog a few years ago …”.

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