Acupuncture works for polycystic ovary syndrome except when it doesn’t–which is always

ResearchBlogging.orgFor some reason, when it comes to so-called “complementary and alternative medicine” (CAM) therapies, acupuncture gets a pass. Homeopathy, for example, is based on ideas so inherently ridiculous that they quite properly attract the scorn of skeptics and advocates of science-based medicine everywhere, stating, as it does, that diluting a remedy to nonexistence makes it stronger, but only if you shake vigorously between each serial dilution step. The same is true of reiki, which, as I’ve said time and time again, is nothing more than faith healing based on Eastern mystical beliefs rather than Christianity. Then there’s reflexology, which claims that every organ in the body maps to a specific location on the hands and feet. Somehow, most people can understand that all of these forms of woo are based on prescientific beliefs unsupported by science, the sort of beliefs that one can understand as having been not unreasonable back before the scientific basis of so many diseases was understood. These days, not so much.

So why does acupuncture get such a pass? Think about it. The principles of acupuncture claim that there’s “life energy,” or qi, that flows through pathways in the body known as meridians and that sticking needles into specific points on these meridians somehow “unblocks” the flow of qi. This “qi” can’t be detected by science. There’s no evidence that it exists, any more than there’s any evidence that meridians exist. Yet, somehow, acupuncture is commonly viewed as one of the more “plausible” CAM modalities by all too many people, including health care professionals. Indeed, acupuncture is very much a bit of “gateway woo,” a proverbial “foot in the door” behind which the real woo pushes its way into the house of science-based medicine, a fixture of nearly every CAM program, used to treat a huge variety of illnesses based on an even huger variety of pathophysiological mechanisms, none related. But acupuncture can apparently do it all! It’s not just for pain. It’s also for goiter, gout, infertility, allergies, exczema, seborrhea, and apparently psoriasis. Whatever disease there is, chances are that you’ll be able to find an acupuncturist claiming that he can treat it and a study claiming that acupuncture is useful for treating it.

I just saw an example of this the other day in the form of a study from the University of Virginia Charlottesville entitled True and Sham Acupuncture Produced Similar Frequency of Ovulation and Improved LH to FSH Ratios in Women with Polycystic Ovary Syndrome. And where did I find out about it? Where else, in a Research Spotlight from the National Center for Complementary and Alternative Medicine (NCCAM) entitled No Difference Between Actual and Simulated Acupuncture for Polycystic Ovary Syndrome, Study Finds. Polycystic ovary syndrome (POS) is a common syndrome among women characterized by irregular or absent menstrual periods, manifestations of too much androgen, including hirsutism (hair where it doesn’t belong) and acne, as well as insulin resistance. It’s a syndrome that commonly leads to infertility, among other problems. So what’s the answer? Acupuncture, of course! The authors set the stage:

Of women seen in a reproductive endocrinology/fertility clinic, 22% had tried acupuncture therapy within 18 months of their initial clinic visit in the United States (6) [12.5% within 6 months in Australia (7) and8%use in the United Kingdom (8)]. The four publications [sample sizes ranged from 24 to 45 women (9 -12)] on acupuncture for women with ovulatory disorders reported acupuncture to be effective for restoring regular menses, regular ovulation, and/or achieving pregnancy.

So what we have here is the typical lousy evidence for the efficacy of acupuncture in anything. Two of the studies were of “electroacupuncture” (which is not acupuncture at all unless the ancient Chinese had access to battery or generator technology); one was of auricular acupuncture; and the other was published in the Journal of Traditional Chinese Medicine, which doesn’t exactly inspire an overwhelming degree of confidence in its results. Be that as it may, the important thing is the current study, at least for purposes of this blog post. It’s a randomized, double-blind, sham-controlled clinical trial involving 84 reproductive age patients with PCOS and no hormonal intervention for at least 60 days prior to the start of the trial. The intervention included 12 sessions of either true or sham acupuncture, and the outcome measures examined included ovulation measured with weekly blood or urine samples and measurements of serum hormones LSH and FSH to determine if they normalize in response to treatment. The randomization schema is illustrated below:

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As always, whenever I look at an acupuncture study, I look first at the specific sham acupuncture needles used and the specific acupuncture regimen chosen:

Subjects in both groups had 12 acupuncture/sham session: twice each week for the first 4 wk followed by once per week for an additional 4 wk. There were four study acupuncturists, each of whom implemented both protocols. For the true acupuncture treatment, the following bilateral points were stimulated with electroacupuncture: bladder 23, bladder 28, spleen 6, and spleen 9. The following points were manually stimulated: pericardium 6, triple energizer 5, and governor vessel 20. The sham acupuncture was performed with the validated Park sham device (20, 21). The sham device was placed on the skin at standardized points on all four extremities (Achilles tendon and lateral head of the triceps) chosen to avoid standard acupuncture meridians and acupuncture points (22). For further details, see the Supplemental Data, published on The Endocrine Society’s Journals Online web site at http://jcem.endojournals.org.

Here we go again. This study uses so-called “electroacupuncture” as well, which again is not acupuncture at all. At least the Park sham device is a real sham acupuncture device that appears to work well for blinding.

So what does this study show? Guess:

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And:

Both arms demonstrated a similar mean ovulation rate over the 5 months (0.37/month among n 40 true acupuncture and 0.40/month among n 44 sham participants, P=0.6), similar LH to FSH ratio improvement (0.5 and 0.8 true and sham, respectively, P=0.04 after intervention vs. baseline) and a similar decline in LH over the 5-month protocol (P=0.05). Neither arm experienced a change in FSH. There were seven pregnancies (no difference by intervention, P=0.7). Lower fasting insulin and free testosterone were highly correlated with a higher ovulation rate within the true acupuncture group only (P=0.03), controlling for prestudy menstrual frequency and body mass index.

We were unable to discern a difference between the true and sham acupuncture protocols for these women with PCOS, and both groups had a similar improvement in their LH/FSH ratio.

In other words, even using “electroacupuncture,” there’s no difference in any outcome measure that matters between sham and “real” acupuncture. True, the investigators thought they saw some mostly barely statistically significant changes in some hormones:

The researchers found no difference in participants’ monthly ovulation frequencies from either group. Both groups, however, had an improvement in the ratio of luteinizing hormone to follicle-stimulating hormone during the 8-week intervention. But only the actual acupuncture group significantly sustained this improvement during the 3-month followup. In addition, the researchers found that two biological factors (fasting insulin and free testosterone) were inversely correlated with the frequency of ovulation in the actual acupuncture group, but not the sham group.

Great digging through multiple comparisons to find a couple of correlations that probably don’t mean anything! Let’s just put it this way. Who cares? Given the multiple comparisons it was almost inevitable that something would shake out as appearing to be a “positive” correlation. If there’s no difference in the frequency of ovulation or successful pregancies between the two groups, one really has to question the significance of this finding. I mean, really. Look at the number of factors tested for, and look at how the investigators had to contort the data to find that two factors were inversely correlated frequency of ovulation, but only in the acupuncture group.

Also, it’s always amusing to see how the authors try to spin this completely negative study. They first note that their acupuncture protocol and the sham protocol both resulted in the same frequency of ovulation and a similar reduction of the LH to FSH ratio in PCOS. From this they somehow conclude that “this acupuncture protocol was more effective for women with less severe metabolic disturbance (lower fasting insulin) or less androgen production (lower free testosterone) because neither of those factors were related to the ovulation rate among the participants in the sham arm.” Uh, right. They then go on to do a whole lot of handwaving about the fact that sham acupuncture was no different from “true” acupuncture. As is the usual case for true believers, instead of concluding the obvious, mainly that acupuncture doesn’t work and it doesn’t matter where you stick the needles, they try to claim, based on the tiniest of differences described above, that there must be two different physiological mechanisms behind sham and true acupuncture. I suppose that could be true, given that unlike the true acupuncture needles the sham acupuncture needles were never hooked up to the electricity, but so what? There was no detectable physiological difference where it counted. Not that that stops our woo-loving investigators from finishing with this howler of a conclusion:

This study suggests that this acupuncture regimen may be beneficial to women with lower fasting insulin and free testosterone levels. This is good news for women with PCOS who are seeking pregnancy because acupuncture may be a nonpharmaceutical option for them without any known fetal or multiple gestation risks. The safety of acupuncture is documented (31) and supported by few adverse events in this trial.

There is a clinical need for treatment options for women who are clomiphene resistant; thus, research on acupuncture treatment in this population would have high clinical value. It would also be informative to investigate the pathophysiology of both true and sham acupuncture. Not only is it confusing to the public to learn that a placebo is equivalent to an active intervention, but it also raises questions about the active intervention that may or may not be warranted.

And what do the investigators base their speculation that acupuncture might be a nonpharmacologic option for women with PCOS trying to get pregnant? Certainly not on anything in this paper. But it is safe. Too bad it isn’t effective. In any case, the conclusion, as they say, does not follow from the data. How on earth did this get past the peer reviewers?

However it managed to slip through review, I must admit that I chuckled heartily at the last paragraph, particularly the last sentence. In fact, I’d add that it’s clearly not confusing just to the public that placebo is equivalent to the active intervention. It’s confusing to the investigators too. The correct answer to that conundrum is that acupuncture doesn’t work for this condition, but instead the authors do backflips of logic to try to torture their data into supporting a therapeutic effect for acupuncture in PCOS. Given that, it’s utterly ridiculous to claim that it would be useful to investigate the pathophysiology of both true and sham acupuncture. Why? Because neither work more than placebo! It also shows, contrary to the authors’ views, that the questions about the active intervention raised by this study are more than warranted. Sadly, the authors just can’t see that, and neither, apparently, can NCCAM, which funded the study.

REFERENCE:

Pastore LM, Williams CD, Jenkins J, & Patrie JT (2011). True and Sham Acupuncture Produced Similar Frequency of Ovulation and Improved LH to FSH Ratios in Women with Polycystic Ovary Syndrome. The Journal of clinical endocrinology and metabolism PMID: 21816787