Mar 11 2010

Acupuncture Does Not Work for IVF

Acupuncture is a so-called complementary and alternative medicine (CAM) modality I frequently tackle because it often provides excellent  teaching points on the relationship between science and the practice of medicine. My reading of the literature is that acupuncture is highly implausible and the evidence does not support its efficacy for any indication.

And yet it is one of the more popular CAM modalities (although still a small phenomenon – only 6% of Americans have ever used it), especially in its penetration of hospitals and academia. There is a great deal of misinformation out there about acupuncture, and this seems to garner the most attention from naive physicians.

In vitro fertilization (IVF) is one of the applications of acupuncture that has been most touted by proponents. The evidence for any positive effect from acupuncture for IVF, however, has been consistent with no effect. By this I mean that there are poor quality studies with mixed results, but trending positive (as poor quality studies tend to do), especially in China and other nations culturally predisposed to acupuncture, but the better designed studies tend to be negative.

There have been a number of systematic reviews of acupuncture trials for IVF with mixed opinions. The most recent review was conducted by the British Fertility Society, and they conclude:

The guidelines found that there is currently no evidence that having acupuncture or Chinese herbal medicine treatment around the time of assisted conception increases the likelihood of subsequent pregnancy.

They reviewed 14 randomized controlled trials and performed meta-analyses on the various outcomes and timing of treatment, and in all cases found no difference between acupuncture and control groups. Other systematic reviews have also come to the same conclusion, for example this 2008 review concluded:

Currently available literature does not provide sufficient evidence that adjuvant acupuncture improves IVF clinical pregnancy rate.

Yet other reviews came to different conclusions. This BMJ review from 2008 concluded:

Current preliminary evidence suggests that acupuncture given with embryo transfer improves rates of pregnancy and live birth among women undergoing in vitro fertilisation.

Why the discrepancy? Partly it is due to a judgment call – the difference between “preliminary evidence is positive” and “there is insufficient evidence” – which is likely a result of the biases of the reviewers. How much weight do you put on preliminary evidence. Those reviews that emphasized the best studies (which I think is the appropriate approach) showed no effect from acupuncture.

One of the best studies of acupuncture in IVF was this one published in 2009. They found that placebo acupuncture was better in some measures than true acupuncture, although no better in others. The authors should have concluded that acupuncture simply does not work, and that these differences found were likely due to chance. However, they concluded that:

Placebo acupuncture was associated with a significantly higher overall pregnancy rate when compared with real acupuncture. Placebo acupuncture may not be inert.

This is just bizarre, but not uncommon in the CAM world. It is just a form of special pleading to argue after a negative trial that placebos work also. In this study the authors are left trying to justify the conclusion that placing the needles in the “correct” locations had a disadvantage over placing them in random locations, which would also mean that expertise in acupuncture is a disadvantage.

Proponents of acupuncture, following the BFS announcement, were quick to insulate themselves from the evidence using special pleading.

One high-profile practitioner, Dr Xiao-Ping Zhai, of The Zhai Fertility Treatment Clinic, said there were indeed problems with the way in which these trials were designed and that different analysis would show the benefits.

“Certainly for those with unexplained fertility problems in particular, we know acupuncture and traditional Chinese medicine can be beneficial. What matters is both the expertise and experience of the practitioner, but most of all the treatment of the patient as an individual. It is the tailored treatment which is key.

My primary question for Dr. Xiao-Ping Zhai is – how does he know that acupuncture works to improve IVF success? He seems to be taking the classic pseudoscientific approach of using science to validate beliefs, rather than test them. When controlled trials are negative, proponents then blame the trials – they must be wrong, because they “know” that acupuncture works.

One of their tactics is to claim that acupuncture needs to be “individualized” – using a standard treatment does not work. But they are unable to provide a coherent explanation for why individualization should matter, at least in physiological terms. Invoking “life energy” and the flow of “chi” is nothing but superstition.

But even if we grant for the sake of argument that individualization of treatments makes a difference, that does not mean the existing trials are wrong and acupuncture works. At best it means we still do not know if acupuncture works for IVF. It is now on the proponents of acupuncture to design and execute what they claim are better trials that allow for individualization.

The problem with this historically is that such trials sacrifice some of the blinding in order to individualize. They have to be especially careful in their design to accomplish both ends – individualized and properly blinded. This has been done, in acupuncture for back pain, for example, with no difference between standardized and individualized treatment groups. So far the “individualization” special pleading has not been supported by the evidence.

“Expertise and experience” also does not seem to matter. This is just another claim without evidence. It may seem intuitive that experience should matter, but actually it matter far less than experts (including physicians) would like to think. To clarify this point – this is in the context of applying treatments. Generally speaking, following evidence based guidelines yields better results than shooting from the hip based upon personal experience.

I would also argue that expertise in a pseudoscientific discipline should be considered pseudoexpertise. Knowing where to place acupuncture needles according to complex Traditional Chinese Medicine principles would only matter if the TCM principles were valid. However, the totality of acupuncture research is consistent with the interpretation that it does not matter where you place the needles – so all that expertise appears to be worthless. It is the equivalent of being able to provide an expert astrology reading – expertise in astrology matters not, because astrology is 100% nonsense.

At the very least, if proponents are going to argue that existing evidence against the efficacy of acupuncture for IVF should be dismissed because the treatments were insufficiently individualized or that they were given by insufficiently experienced practitioners – they should provide evidence that either of these things matter. And even worse, they are committing the logical fallacy of concluding not only were the trials not definitive, but that acupuncture works (rather than it is still unknown).

What about plausibility? Proponents argue thusly:

A statement from the British Acupuncture Council noted: “Fertility focused acupuncture treatment has been found to help increase blood flow to the reproductive organs, balance hormone levels, regulate the menstrual cycle and help improve the lining of the uterus and quality of eggs released.”

This is a common ploy by proponents of dubious treatments – they cite research which essentially amount to anomaly hunting – looking for physiological changes that correlate with the treatment. First it must be pointed out that basic science evidence, like physiological changes, should not be used to extrapolate clinical claims – the clinical evidence for efficacy must also be there, and it isn’t.

But the more subtle point is that medical researchers are familiar with the fact that if you do something to an organism or a clump of cells and then look for changes, you will find them. Biological systems respond to stimulation. Stick a needle in someone and there will be a local inflammatory reaction, causing a host of changes.Are any of these changes actual markers or causes of a specific clinical effect? That is a different question.

Further, biological systems are highly variable, so looking for changes is often rewarded. Knowing what those changes actually mean is another matter.

When anomaly hunting for physiological changes is rewarded, proponents also often make another unjustified leap of logic, assuming that “changed” equals “improved.” So changes in hormone levels becomes “balance hormone levels” – without any evidence that the non-specific changes represent a functional improvement.

The take-away message is that finding changes in physiological markers in correlation with a treatment is helpful in designing future research and both testing and generating hypothesis – but they are no substitute for clinical research. Finding physiological changes is also not as impressive as is often presented – it is actually an extremely poor predictor of clinical efficacy. Anyone doing translational research is keenly aware of this – most treatments that are promising based upon pre-clinical evidence do not pan out clinically.

Conclusion

Acupuncture remains an implausible treatment, and lacks sufficient evidence to conclude that it works for any specific indication. The history of acupuncture research is following a familiar pattern. Initial research is mixed but trends positive. Basic science research shows non-specific anomalies, but no consistent pattern that accords with scientific theory of mechanism for acupuncture. For each indication, as better and more rigorous studies are designed, the effects shrink until the best studies are negative.

Proponents then engage in special pleading to dismiss the evidence, while simultaneously citing poor quality or pre-clinical evidence, secure in their faith that acupuncture works.

We see this pattern with homeopathy research, the ESP literature, UFO investigations, and all manner of fringe science. Recognizing this pattern is essential to interpreting any large body of such research.

Share

20 responses so far

20 Responses to “Acupuncture Does Not Work for IVF”

  1. David in NYCon 11 Mar 2010 at 1:53 pm

    I don’t want to become the guy that questions every post, but on this I must chime in.

    My six-year old twins, my normally-skeptical wife, and one of the top IVF doctors in America might disagree.

    We went through two failed rounds of IVF in New York City, and acupuncture was recommended by one of the top clinics in America (I won’t mention the name, but the success rate is annually in the top three of all clinics in the nation).

    After an intense series of acupuncture treatments, my wife became pregnant and carried our twins to 32 weeks. They are now six years old and, thank G-d, very healthy.

    Sure, it could have been a more aggressive course of hormones on the third try, it could have been that her system had been primed sufficiently, it could have been that she ate the right things the third time and the wrong things the first two.

    However, all involved believed the acupuncture made the difference. Maybe just that belief was enough?

    One story does not a proof make.

    Yet, as in my previous comments earlier this week, we must be comfortable with the idea that science might not yet have the tools to measure all the intricacies and remaining mysteries of the human body.

    David in NYC

  2. Steven Novellaon 11 Mar 2010 at 1:58 pm

    David,

    I am glad things worked out for you. But as you note – there were other variables in play. It is simply not possible to conclude from a single anecdote (even your own) that acupuncture had any effect.

    The “science is not adequate” claim simply does not hold water. If there is an effect, it can be detected. If it goes away every time you add controls – that is compatible with no effect.

    In this case the thing to be measured (pregnancy rates, live birth rates) are really easy to measure – objectively and quantitatively. Any significant effect should be easy to detect. Studies show there is no effect.

  3. HHCon 11 Mar 2010 at 2:15 pm

    David in NYC, Needles and sexual stimulation can be associated. Sexual activities may be responsive to pain/pressure. Witness the increase in body piercing and paraphernalia.

  4. CivilUnreston 11 Mar 2010 at 3:56 pm

    David, scientists are often proven wrong when they thought they were correct. This is an invaluable feature of science that few other systems of knowledge share.

    That being said, the slim chance that the science is wrong about acupuncture (which I’m sure Dr. Novella will admit is a remote possibility) is not evidence enough to accept it. Thus far, we have no good proof that it works, only anecdotes. Treatment modalities that are effective generally rise above their counterparts specifically because they are effective — acupuncture has not done this.

    What am I getting at? You’re right, science MAY not be advanced enough to understand how acupuncture works (assuming it works). The problem is that I have no reason to give acupuncture the benefit of the doubt — I have no reason to assume that it works. Even if it’s mechanism is mysterious, its clinical effects (by definition) should not be.

    As soon as acupuncture proves itself, I’ll jump on board. Until then, it’s just a bunch of anecdotes, and (to reuse my favorite phrase) the plural of anecdote isn’t data.

  5. Karl Withakayon 11 Mar 2010 at 5:12 pm

    David, did you ever try something multiple times, failing every time but the last time? When you succeeded, did you automatically credit the last change in method with the success? Did you ever then repeat the last method several times, only to find the success was due to random chance (or some other confounding factor), and not the last method used?

    I work in IT, and I can’t tell you how many times I thought I had a problem figured out only to find out that my theory didn’t hold up to repeated experimentation.

    Pick a number on the roulette wheel. Place a bet each time the wheel is spun, choosing a different magic work to shout when the ball is released. Keep repeating until you finally win; given enough time & money, you’ll eventually hit the jackpot. Did you win because you figured out the correct magic word?

  6. BKseaon 11 Mar 2010 at 5:46 pm

    In evaluating accupuncture, it seems to me there are three questions to be asked: 1) is there any effect (placebo included) at all?, 2) what is the mechanism of the effect if it exists?, and 3) Is there an alternative, better approach that operates by the same mechanism?

    It seems to me that the studies that compare “real” accupuncture to sham or non-specific accupuncture address question 2 (i.e. is accupuncture just a placebo?). I would like to first see evidence that the answer to question 1 is “yes.”

    In IVF, I have a hard time believing there would be any effect at all. I would especially like to see a study of accupuncture versus no accupuncture on rate of pregnancy. Has this been done?

  7. Enzoon 11 Mar 2010 at 7:19 pm

    I couldn’t tell by the article if the statement made by the British Acupuncture Council

    “Fertility focused acupuncture treatment has been found to help increase blood flow to the reproductive organs, balance hormone levels, regulate the menstrual cycle and help improve the lining of the uterus and quality of eggs released.”

    was something that was backed up by scientific studies (even bad ones) or if this was just a random claim without evidence.

    Dr. Novella, you seem to treat them as if the data were from legitimate studies that have been conducted. I wonder if this is coming from multiple studies or one study. I only ask because some of those claims require considerable testing and sampling to investigate. Improving uterine lining and egg quality?

    I’m sure looking at the actual studies (if there are any) would show the true colors, but it seems to be a little dismissive to call things like that irrelevant physiological changes. I wonder if they have data from actual IVF recipients showing correlations between those claims and eventual success. I’m certainly not trying to be a proponent for acupuncture but I just thought the treatment was a bit unfair.

    That being said, a search of the British Acupuncture Council website (Research/Review Papers/Gynaecology) does not have references that support the quote’s claims. Only some articles about general dysmenorhea and uterine bleeding.

  8. HHCon 11 Mar 2010 at 11:04 pm

    If fertiliity is stimulated by acupuncture needles, then I would inquire if the indiviudal is stimulated by any sharp on a chosen area of the body which is studied. Would satisfactory stimulation of the area, producing a similar sensation be responsible for the the placebo findings? Note the person receiving the sensation would continue to be controlled by an authority figure as part of the study.

  9. Steven Novellaon 12 Mar 2010 at 9:07 am

    Enzo – I could not find the studies, so they are either not published or not listed on PubMed. The claims are unreferenced. So the basic claims themselves may be bogus. If they are correct, however, I am not being dismissive of them, just pointing out that this type of physiological correlations are not as impressive as they are made to seem. They often amount to nothing but anomaly hunting. Unless you have data from multiple angles showing that they are meaningful and predictive.

    Given that I cannot even substantiate the raw claims, I doubt all the follow up data exists to put them into biological context.

  10. HHCon 12 Mar 2010 at 9:45 am

    The findings for acupuncture would best be classified under fertility rituals. Cultural history rather than medicine.

  11. superdaveon 12 Mar 2010 at 11:00 am

    Ive heard people claim that acupuncture works because it causes some nonspecific inflammation response. This unplasusible explanation is a poor rationale for explaining how acupuncture works for pain, but how is hell does it come even remotely close to explaining anything about fertility. How could the same treatment also effect pain, depression and fertility? Why don’t drugs that effect pain also effect depression and fertility? Why don’t fertility drugs effect pain?

  12. CivilUnreston 12 Mar 2010 at 4:38 pm

    Whereas “western” medicine works off of the relative motion of conductors and fluxes, acupunture’s effect is produced by the modial interaction of magneto-reluctance and capacitive diractance

  13. SquirrelEliteon 12 Mar 2010 at 8:50 pm

    @CivilUnrest,

    In other words, acupuncture’s effect is science fiction.

    http://spacecollective.org/joshuas/1517/-Modial-Interaction-of-Magneto-Reluctance-

  14. BillyJoe7on 13 Mar 2010 at 6:24 am

    What? You don’t believe him?

  15. daedalus2uon 13 Mar 2010 at 8:06 pm

    Fertility and conception is highly highly highly regulated functions. It is one of the most important functions that organisms have (if not the most important function). Every organism is only descended from organisms that successfully reproduced.

    Acupuncture is a completely non-physiological intervention. No pre-human ancestor used needles to control their physiology, acupuncture is a very recent technological intervention dating from only a few thousand years ago, maybe a few hundred generations and then only in the few cultures that used acupuncture. Many cultures have never used acupuncture, many individuals being treated with acupuncture in the West now, are very likely the first person in their line of descent to ever have been subjected to acupuncture needling.

    There are mechanisms by which acupuncture could work via non-specific effects such as the placebo effect, stress relief, anxiety reduction. We know things like that affect fertility. We need to exclude those ordinary effects of acupuncture before we need to posit any extraordinary effects of such a non-physiological intervention on something as highly regulated as fertility.

  16. BillyJoe7on 14 Mar 2010 at 6:41 am

    daedalus,

    “There are mechanisms by which acupuncture could work via non-specific effects such as the placebo effect, stress relief, anxiety reduction.”

    Stress relief and anxiety reduction are also placebo effects, so your statement reduces to: “Acupuncture could work via a placebo effect”, but what you really mean is something like: “Acupuncture itself has no effect, but there is a placebo effect [which is often mistaken for an effect of acupuncture itself]”
    At least I think that is what you mean.

  17. daedalus2uon 14 Mar 2010 at 12:17 pm

    BillyJoe, yes, sorry if I was being confusing. All of the effects of acupuncture are indistinguishable from placebo. When the effects of something are indistinguishable from a placebo, then it is a placebo. Acupuncture is a placebo.

    I have a very clear definition of what a placebo is. Usually others do not have such a clear definition. To me, any treatment that achieves positive therapeutic effects without a pharmacology or surgery (or something else mechanical-ish), does so by placebo effects and is a placebo.

    A placebo has to have to components, it has to actually produce a therapeutic effect, and it has to do so via non-chemical and non-mechanical methods.

  18. JimRon 23 Mar 2010 at 10:32 pm

    Dr. Novella, thank you for the work you’ve been doing. I’ve been listening to and enjoying the SGU podcast for a couple of weeks now.

    This particular issue fascinates me for a couple of reason. The first is that my wife and I are going through some fertility issues and there has been some discussion of IVF with her doctors, and second, I live in Japan where acupuncture/traditional Chinese medicine is deeply ingrained into the culture (herbal medicines are available by prescription, for example). However, despite the concurrence of these two facts, acupuncture has not ONCE been mentioned in addressing our fertility issues.

    What HAS been discussed is the emotional/psychological aspect of fertility, i.e. excessive stress caused by worrying about fertility can have adverse effects on hormonal levels and other essential elements of conception. Thus, I am inclined to believe that any ostensible benefit from acupuncture is attributable to its placebo-like psychological effect.

    My question, then, is: is this actually a bad thing? Even if it’s a placebo, if the placebo effect is beneficial, isn’t that enough? If a person is unable to control their worry, but the totemlike effects of acupuncture do, in fact, help ease the mind and improve the chances of conception, well…isn’t that a win?

  19. julieon 03 Apr 2010 at 6:20 am

    Many IVF clinics offer refer their clients to acupuncturists. IVF is very expensive (around $10,000) and often not covered by insurance, so patients think that spending just a little more money to increase their chances is worth it. Doctors often have brochures for local acupuncture clinics in their waiting rooms, and yes, many doctors do believe that acupuncture helps. I hope that situation will change. It seems unfair to patients who would naturally do anything to improve their odds to offer them just another way to spend money.

  20. IVFeron 24 Apr 2010 at 8:36 pm

    Steve, I am curious to know what you think of Westergaard et al’s (2006) study, published in Fertility and Sterility, that demonstrated positive effects of acupuncture on IVF success rates? I assume you see this study as flawed? I’d be interested to hear your opinion on it (and other similar studies with similar positive results).

Trackback URI | Comments RSS

Leave a Reply

You must be logged in to post a comment.