Once again, acupuncture doesn’t work for menopausal hot flashes [Respectful Insolence]

Of all the forms of quackery that have been “integrated” into medicine of late, arguably one of the most popular is acupuncture. It’s offered in fertility clinics. It’s offered in hospitals and medical clinics all over the place. The vast majority of academic medical centers that have embraced quackademic medicine offer acupuncture. (Quackademic medicine, for those not familiar with the term we reserve for the study of alternative medicine in academic medical centers that really should recognize it as quackery.) Hell, quite a few that haven’t embraced quackademic medicine offer acupuncture. Basically, acupuncture is the gateway drug of “complementary and alternative medicine” (CAM) that is often a harbinger of the harder stuff, like naturopathy and homeopathy. Basically, if you believe its adherents, acupuncture can work for practically any symptom caused by pretty much any condition.

It’s also pure placebo medicine, or, as David Colquhoun and Steve Novella put it, acupuncture is a “theatrical placebo.” As I’ve asked time and time again, Can we finally just say that acupuncture is nothing more than an elaborate placebo? Can We? As I’ve said before, if you look at the evidence for acupuncture critically and in its totality, acupuncture has no specific effects and no effects distinguishable from placebo. Indeed, it doesn’t matter where the needles are inserted, in “real” or “sham” acupuncture points, or even if the needles are actually inserted in the skin. It’s all the same.

One of the most popular uses for acupuncture is to treat menopausal symptoms. I’m familiar with this literature because the anti-estrogen drugs used to treat hormone-responsive breast cancer often produce menopausal symptoms. Indeed, among practitioners of “integrative medicine” (the art of integrating quackery with real medicine), there’s a great deal of enthusiasm for acupuncture for menopausal symptoms. Never mind that clinical studies have been consistently unimpressive. None of this, however, prevents acupuncture advocates from continuing to do clinical trials.

Here comes another one from a couple of months ago that I heard about over the weekend. It’s hot off the presses in Annals of Internal Medicine by Carolyn Ee et al from Australia and Canada, specifically, Melbourne Medical School, University of Melbourne; Royal Melbourne Institute of Technology University; Southern Cross University, Queen’s University in Ontario, and Monash Health in Clayton, Victoria, Australia. It is a randomized clinical trial of acupuncture for hot flashes. What’s different about it is that it’s a clinical trial for regular menopausal hot flashes, not for hot flashes caused by breast cancer treatment, as most of the clinical trials of acupuncture for hot flashes that I read are. Let’s take a look.

Basically, this trial enrolled women older than 40 in the late menopausal transition or postmenopause with at least 7 moderate hot flashes daily. Hilariously (I have to laugh so that I don’t cry, thinking of the resources wasted on this therapy and the unethical nature of it all, given that acupuncture is mystical pseudoscience) the authors further note that these women thus met the criteria for traditional Chinese medicine diagnosis of kidney yin deficiency. Curious just what the heck “kidney yin deficiency” is, I looked it up. Here’s a description. First of all, kidney yin is:

When The theory of yin and yang is used to explain the organic structure of the human body; the physical form pertains to yin, while activities or functions pertain to yang. The physical forms are the material basis for functions, while functions are the motivating power for physical forms. They are mutually complementary. TCM views the kidneys as the center of the body’s yin and yang, the “congenital foundation,” or the origin of life. In other words, the kidneys store the primordial yin and primordial yang (also called kidney yin and yang), which is the place where nutrients are stored and physiological functions take place.

Kidney yin, also called primordial yin, true yin or true water, is the foundation of the yin fluid of the whole body; it moistens and nourishes the organs and tissues.

TCM kidneys Kidney yang, also called primordial yang, true yang or true fire, is the foundation of the yang qi of the whole body; it warms and promotes the functions of the organs and tissues.

This is, of course, utterly unscientific, based as it is on concepts not at all unlike the concepts behind “traditional Western medicine,” namely the idea that “imbalances” in something are the cause of all disease. In the case of traditional Western medicine, it’s an imbalance in the four humors. In traditional Chinese medicine, it’s an imbalance in the five elements. In any case, what are the symptoms of kidney yin deficiency? Not surprisingly, some of them resemble menopause:

Presentations of kidney yin deficiency include: soreness and weakness of the lumbar regions and knees, dizziness, ringing in the ears, hearing problems, a dry mouth and throat, a hot sensation in the palms, soles and chest, spontaneous sweating, constipation, and seminal emission. The pulse is weak or fine and rapid; the tongue is red and covered with a light coating of fur. Kidney yin deficiency syndrome always produces signs of yin vacuity internal heat.

According to Ee et al:

Women were included if they were postmenopausal (>12 months since their final menstrual period) or in the late menopausal transition (follicular-stimulating hormone level ≥25 IU, amenorrhea ≥60 days, and VMSs), had a mean HF score of at least 14 (equal to 7 moderate VMSs daily) (16), or had kidney yin deficiency diagnosed using a structured Chinese medicine history as well as a tongue and pulse examination performed by experienced acupuncturists (Appendix Figures 1 and 2). Kidney yin deficiency, of which night sweats is a cardinal symptom, is a Chinese medicine clinical syndrome diagnosed in 76% to 81% of symptomatic postmenopausal women (17, 18).

They were even kind enough to provide a questionnaire to diagnose kidney yin deficiency:

QUESTIONNAIRE

As you can see, this questionnaire is so vague as to be pointless. Certainly, it’s not enough to diagnose menopause. After all, there are no questions about frequency of menstrual periods or when the subject’s last menstrual period was, and the questionnaire includes information about Chinese pulse diagnosis, which is not reproducible, and Chinese tongue diagnosis, which is basically reflexology on the tongue.

So far, not so good.

Basically, 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). The study was blinded, but not completely. Study design was a stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. Overall, it wasn’t a bad design as far as acupuncture studies go. True, it lacked blinding of the treating acupuncturist, which would have been required for a true double-blind study design, but it did use a pretty good acupuncture sham, the fake retractable needles that don’t break the skin also inserted in the “wrong” places. Participants received 20 minute acupuncture sessions (or sham acupuncture sessions) twice weekly for two weeks and then weekly thereafter.

So what were the results? Do you even have to ask? Basically, this was a completely negative trial, which is why I wasn’t as concerned about whether or not the acupuncturists were blinded or not. (This would have been a much bigger issue if there had been a positive result.) At the end of the eight week treatment period, Mean hot flash scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (P = 0.77). Hot flash scores declined about 40% in both groups and persisted for six months. The investigators couldn’t find evidence of an advantage of acupuncture over sham acupuncture on quality of life, anxiety, or depression. That’s about as negative as it gets. I do have to give the investigators credit. They didn’t try too hard to torture the data to provide the result they wanted with post hoc analyses, as many investigators carrying out clinical trials are tempted to do.

They did, however, try to make excuses. Indeed, the shorter version of the whole discussion section seems to be: How can it possibly be that we didn’t find acupuncture to be superior to sham for menopausal hot flashes? They noted:

Our findings are consistent with those from a recent Cochrane review (10), which reported that acupuncture was more effective than no treatment and had a moderate effect size but was not efficacious when compared with sham. Although another recent meta-analysis reported moderate standardized effect sizes of acupuncture of −0.35 and −0.44 for HF frequency and severity (13), this analysis pooled data from sham-controlled trials and trials comparing acupuncture with no treatment. In addition, the shortcomings of the included studies (small sample sizes, high attrition rates, and failure to use intention-to-treat analyses) may have inflated the treatment effects.

Which, of course, leaves the question of why bother to do this study in the first place, given that there’s enough evidence out there to do a Cochrane review and that review found no evidence that acupuncture was more efficacious in menopausal hot flashes than sham acupuncture, and there was enough evidence to do a meta-analysis whose results were probably due to the inclusion of low quality evidence. There was (and is) no strong clinical or scientific rationale to do randomized studies of acupuncture for menopausal hot flashes.

This next paragraph made me chuckle out loud as I read it:

The first limitation of our trial and acupuncture clinical research more broadly is the lack of an inert sham comparison treatment. Although the Park sham device was the best available sham acupuncture method at the time of study design, its validity as an effective control treatment needs further determination. It creates a needle-prick sensation, essential for the patient to believe that a needle has been inserted; however, this sensation produces minor physiologic effects (26). The interpretation of sham-controlled acupuncture trials must occur within this context. However, what we have successfully examined is the effect of needling compared with pressure from a blunt needle. Second, despite our broad recruitment strategy, our findings can only be generalized to Caucasian Australian women with kidney yin deficiency. Nonetheless, 87% of otherwise eligible women met criteria for symptoms of kidney yin deficiency, consistent with previous studies (17, 18). Third, our method of Chinese medicine diagnosis was a simplified version of usual practice and failed to define secondary diagnoses. In addition, our acupuncturists could not be blinded, but we provided comprehensive training and performed quality assurance visits to minimize bias. Finally, our findings cannot be generalized to women with bilateral salpingo-oophorectomy or worsening of VMSs after breast cancer; we excluded these women because they have more severe VMSs (47, 48). Future research should examine the role of acupuncture in breast cancer.

Yes, let’s count the excuses. The sham needles weren’t an adequate control. Our findings can’t be generalized to all women with menopause but only to Caucasian Australian women who also—by the way—have kidney yin deficiency. Our method of traditional Chinese medicine diagnosis was too simplified. Our acupuncturists couldn’t be blinded. We can’t generalize our findings to women with menopause doe to surgery or to breast cancer treatment. So let’s study the role of acupuncture in alleviating menopausal symptoms in breast cancer patients.

Oh wait. There’s already sufficient evidence out there (e.g., studies like this one) to show that acupuncture doesn’t work for menopausal symptoms in breast cancer patients; that is, other than studies that don’t bother to blind anybody.

So once again, we have yet another study that shows that acupuncture doesn’t work, and once again we have investigators who refuse to believe their own results and have to be dragged, kicking and screaming, by the data to the conclusion that their hypothesis was false. Even then, they can’t help making lots of excuses and planning their next study even though this one was totally negative.

Same as it ever was.