Dr. Oz, one half of the You Doctors. And a professor. A professor.

Dr. Oz, one half of the You Doctors. And a professor. A professor.

I receive a monthly newsletter from my medical board. Among other issues discussed are the results of disciplinary actions for physicians. Occasionally a physician who has boundary issues is required to have a chaperone present when doing exams.

I was thinking that the concept of a chaperone could be more widely applicable. Consider “You Docs: Amazing acupuncture,” the latest from Drs Oz and Roizen. Both are professors at their respective institutions. Professors. To judge from the ability to read and interpret the medical literature, both should not be allowed near a journal without a chaperone to remind them about cognitive biases, logical fallacies and what constitutes a good clinical study. Looking at their recent review of acupuncture suggests they lack an understanding of all three.

They start with the argument from antiquity, which is not only wrong as a logical fallacy, it is wrong historically when they say:

acupuncture has been a go-to therapy for 5,000 years.

Off by a factor of about 500. They are unaware that acupuncture as currently practiced is relatively new, having been a form of bloodletting until recently when the modern version with steel needlesbecame popular under Mao.

However, in the early 1930s a Chinese pediatrician by the name of Cheng Dan’an (承淡安, 1899-1957) proposed that needling therapy should be resurrected because its actions could potentially be explained by neurology. He therefore repositioned the points towards nerve pathways and away from blood vessels-where they were previously used for bloodletting.

They explain the mechanism of action as stimulating

points in the body that affect chi or qi, the life energy.

without noting that chi or qi is a fantasy. No life energy has ever been measured and virtually every point on the body is an acupoint in one of the multiplicity of styles that are acupunctures. Except, as mentioned in the past, the genitals.

And they are unaware of the fact that the concept of qi and meridians has more to do with the inventions of Soulié de Morant, a Frenchman of the 1930s, who popularized acupuncture in Europe and that de Morant’s

claims about acupuncture, and the lore of energy meridians and qi, are founded on sloppy translations, misconceptions, or even pure forgery.

They proceed to the appeal to popularity noting that singer Alicia Keys and bike racer Vincenzo Nibali use acupuncture and

North Americans being needled jumped from 2 million in 2002 to more than 14 million in 2007.

I have found that entertainers are not a good source of information for my health care. Rob Schneider and Jenny McCarthy have not been optimal for vaccine advice or TV physicians for dietary supplement advice. The popularity of vaccine refusal has only been good for the spread of whooping cough, measles and mumps. So perhaps the wisdom of the celebrities and the crowd may not be the most reliable source for other health information.

But, they note, the WHO recommends acupuncture for a wide variety of illnesses:

The World Health Organization says acupuncture may help ease digestive problems like constipation and diarrhea; chronic sinus and lung infections; all sorts of pain, from headaches and migraines to neck pain, back pain and osteoarthritis; infertility; and even urinary and menstrual problems.

That weasel word: may. Come to me with pneumococcal pneumonia and there’s no ‘may’ about it. I’ll cure you. Perhaps using acupuncture for lung infections explains why it is the third and fourth most common cause of death in the world.

Here is a problem with newspaper articles: no references. So I have to guess what references the You Docs are using. I suspect they are referring to the 1996 WHO report, described as a

highly flawed pro-acupuncture piece of propaganda, not a scientific review of evidence. It was worthless in 1996, and now it has the added burden of being outdated.

It is a truly appalling work, ignoring prior plausibility, minimizing risks, and also suggesting acupuncture for convulsions in infants, colour blindness (?!?), closed head injury, and progressive bulbar and pseudobulbar paralysis among other diseases. I am sure Dr. Oz will have the courage of his convictions and use acupuncture in lieu of bypass surgery, should he ever need it. The WHO recommends it after all.

They mention that Dr. Mike, the Chief Wellness Officer at the Cleveland Clinic (with concerning difficulties counting as “there are more than 10 certified acupuncture practitioners in the Wellness Institute’s Center for Integrative Medicine”. That would be a number greater than 11 and less than infinity and that represents a lot of acupuncture being done at the Cleveland Clinic) has found

good evidence that it works to ease gastroesophageal reflux, nerve pain and post-surgery pain.

Now if good evidence is small, unblinded, non-placebo controlled trials, then yeah, there is good evidence for gastroesophageal reflux, and nerve pain:

Despite the number of trials of manual acupuncture for DPN and their uniformly positive results, no clinically relevant conclusions can be drawn from this review due to the trials’ high risks of bias and the possibility of publication bias.

or

8 relevant papers were identified. One was an experimental study which showed that electroacupuncture suppressed CIPN pain in rats. In addition, there were 7 very heterogeneous clinical studies, 1 controlled randomised study using auricular acupuncture, 2 randomized controlled studies using somatic acupuncture, and 3 case series/case reports which suggested a positive effect of acupuncture in CIPN. Conclusions. Only one controlled randomised study demonstrated that acupuncture may be beneficial for CIPN. All the clinical studies reviewed had important methodological limitations.

and post-surgery pain

The meta-analysis showed positive results for acupuncture treatment of pain after surgery in terms of the visual analogue scale (VAS) for pain intensity 24 hours after surgery, when compared to sham acupuncture (standard mean difference -0.67 (-1.04 to -0.31), P = 0.0003), whereas the other meta-analysis did not show a positive effect of acupuncture on 24-hour opiate demands when compared to sham acupuncture (standard mean difference -0.23 (-0.58 to 0.13), P = 0.21).

Although there are many postoperative acupuncture pain studies with variable results, the preponderance of literature and high quality studies suggests no efficacy. But the Cleveland Clinic is not a bastion of Science-Based Medicine.

If I am trying to decide on a restaurant or a new pair of shoes I pick ones I tried and enjoyed in the past or have good reviews. When it comes to health care I am a bit more selective in my criteria. I want what is effective in the best clinical trials. For the You Doctors the criteria is

if you’re one of the folks who like the idea (of acupuncture), and the treatments work for you

try it and offer the following as support.

It’s a pain soother: In a new University of California San Diego study, after 31 kids (ages 2 to 17) had tonsillectomies, acupuncture muted their throat aches within minutes.

Retrospective, not blinded, no sham acupuncture, conducted by a clinician who is a believer.

The reported benefits of L14 stimulation is reinforced by the author’s own personal clinical acupuncture experience.

No opportunity for researcher bias here, is there?

A hot-flash cooler: A new review of 12 studies involving 869 menopausal women concludes that acupuncture reduces the number and intensity of this annoying menopause symptom.

Take “Effects of acupuncture on menopause-related symptoms and quality of life in women on natural menopause: a meta-analysis of randomized controlled trials.” There is no reason what-so-ever to suspect that acupuncture would do anything for hot flashes, certainly not by classical Chinese Medicine theory of nonexistent chi and meridians. An article suggests

…that acupuncture caused a reduction in the concentration of β-endorphin in the hypothalamus, resulting from low concentrations of estrogen. These lower levels could trigger the release of CGRP, which affects thermoregulation.

Acupuncture aficionados love to point to endorphin release secondary to sticking someone with a sharp piece of metal for many of the alleged effects of acupuncture. It is much to do about nothing, and would not explain how the ever so laughable laser acupuncture and acupressure would have the same effects. They included many types of acupuncture, some mutually exclusive, in the study:

traditional Chinese medicine acupuncture (TCMA), acupressure, electroacupuncture, laser acupuncture and ear acupuncture.

The mappings in the ear for ear acupuncture are not the same as traditional Chinese acupuncture. But there is no acupuncture, but rather acupunctures plural, as many as there are practitioners, since there is zero standardization of diagnosis and practice of the many forms of this pseudo-medicine.

If you are a Bayesian kind of gal, you would understand that if an intervention has no prior plausibility, then any likely positive results are likely false positives and due to bias.

And the study suggests that any and all positive effects are due to poor methodology and bias. As a rule, effects of pseudo-medical interventions such as acupuncture only have effects for subjective, not objective, endpoints, and the number and intensity of hot flashes is a subjective endpoint.

Key to any clinical trial: if an intervention is no different from placebo, IT DOESN’T WORK. Sorry I shouted. The effect on hot flash frequency or severity appeared to be linked to the number of treatment doses, number of sessions or duration of treatment.

However, they also demonstrated that sham acupuncture could induce a treatment effect comparable with that of true acupuncture for the reduction of hot flash frequency.

The dose and the frequency of the drug made no difference in the outcome and it was no better than placebo. Therefore it works. And so we get misleading headlines suggesting efficacy of acupunctures.

A pound melter: When 91 overweight people followed the same healthy diet and got real or sham ear acupuncture, those who got the real thing lost weight.

  • Small sample size? Check.
  • High dropout rate? Check.
  • Bad statistics? Check.
  • Inadequate blinding? Check.
  • Small effect size? Check.
  • Underlying prejudice/bias in favor of an intervention? Check.
  • Totally improbable intervention? Check.

Ioannidis identified many features that render a clinical trial suspect. It sometime appears that pseudo-medicine researchers try to hit as many of them as possible. Certainly this is the case where ear acupuncture was used as an adjunct to weight loss and found to be effective. Almost every error that could be applied to a study, was. Patients received 5 point ear acupuncture, 1 point ear acupuncture or sham acupuncture for 8 weeks:

Those who received five-point acupuncture had needles placed 2 millimeters deep in one outer ear taped in place and kept there for a week. Then the same treatment was applied to the other ear… Other patients received similar treatment with one needle or with sham acupuncture where the needles were removed immediately after insertion.

I suspect that there was such a high drop out in the sham treatment as because they knew they were not getting acupuncture. A lousy placebo renders an already silly and poorly done trial completely meaningless, like most of the acupuncture trials.

But the real reason this trial is not valid is that Korean ear acupuncture is not real acupuncture. Real acupuncture is traditional Chinese. Or Japanese. Not wait, hand acupuncture. Or foot acupuncture. No, wait, tongue acupuncture. That’s the ticket. Or perhaps it’s the Micro Acupuncture Point System.

An energizer for cancer patients: In two recent University of Pennsylvania studies, women receiving chemotherapy for early-stage breast cancer reported reductions in tiredness, anxiety, depression and joint pain after receiving acupuncture.

Which was discussed by Dr. Novella:

They were treated for 8 weeks with either RA (real) or SA (sum). Outcomes included several scales that essentially involve reporting subjective symptoms. The study found that both groups reported improvement in symptoms with treatment, but there was no statistically significant difference between the two. In the real world we refer to this as a negative study.

So acupuncture includes Chinese, Korean ear and electroacupuncture. Any and all acupunctures are equally useless. Except when the You Doctors read the literature.

The You Docs finish by admitting it is all placebo anyway:

We know that in some studies, sham acupuncture produces results almost as good (or as good) as the real thing. Perhaps the sham technique (pricking acupuncture points) works as well as inserting needles … or, in some cases, acupuncture works because people want it to. Future research will help sort that out.

It has already been sorted out by past research. Acupuncture only has subjective effects when the patient believes it is effective. The You Docs need to read the past literature.

They also suggest making sure that

your practitioner is certified and state-licensed.

As if that makes a difference in quality. There is a letter to Acupuncture in Medicine entitled “Pneumothorax complication of deep dry needling demonstration“. Pneumothorax is a rare but well described complication of acupuncture. I almost feel sorry for the practitioner as in the accompanying video he keeps emphasizing the care that must be done in order to avoid just that complication. Then you see the needle abruptly goes really deep. Pop.

Procedures, even useless procedures, have complications. It happens. But watch the video for the most god-awful adherence to infection control you could ever want to see.

  • No gloves.
  • No cleaning of the site where the needle is going to go (at least on film).
  • His ungloved hands wander all over the patients back.
  • He uses the tube in which the sterile needle sits as a pointer, touching his finger with it
  • As he manipulates the needle up and down in the skin it bows, evidently bouncing against his other hand.
  • And the coup de grace: after taking out the needle he covers bloody spot with his bare finger.

Aarrrrrggggghhhhhhhhhhhhh.

And this from a practitioner of 45 years of experience teaching others how to do dry needling. I cannot tell from the video if hands were washed before the procedure; supposedly they were. It sure gives me the Infection Control willies. It is difficult to infect people, even if you are trying. But not impossible, given the 506 hits searching PubMed for “acupuncture and infection.” The British acupuncturists are not enthusiastic for either gloves or cleaning the skin. Perhaps that number of hits would have been a little smaller if they were more fastidious about infection control.

But I have long noted an unwillingness of pseudo-medical providers to improve practice for the patients’ benefit.

The You Doctors: they do not understand how to read the literature, recognize acupuncture is a placebo, yet go ahead and suggest ways to

get the most out of this healing therapy.

Come to think of it, I do not think a chaperone when reading the medical literature will work.

 

 

Posted by Mark Crislip

Mark Crislip, MD has been a practicing Infectious Disease specialist in Portland, Oregon, since 1990. He is a founder and  the President of the Society for Science-Based Medicine where he blogs under the name sbmsdictator. He has been voted a US News and World Report best US doctor, best ID doctor in Portland Magazine multiple times, has multiple teaching awards and, most importantly,  the ‘Attending Most Likely To Tell It Like It Is’ by the medical residents at his hospital. His growing multi-media empire can be found at edgydoc.com.