Fibromyalgia symptoms: Acupuncture provides relief

http://www.mayoclinic.com/health/fibromyalgia/CM00020

50 people is by far too small a sample size, especially considering that the test group would be 25, and especially considering that the other two studies yielded inconclusive results.

How were the 50 people chosen? That is, by what method were they diagnosed with fibromyalgia, which is a notoriously nebulous (and therefore difficult to identify) condition. If the study just put out a call, for example, asking for "people who have fibromyalgia," then you can expect that a goodly proportion of the respondents would be self-diagnosed.

Or were the subjects diagnosed as part of this study? If so, were the diagnoses double-blind, or did the same researches perform both the original evaluation and the acupuncture assessment? A researcher aware of the nature of the experiment could easily have chosen likely-seeming candidates based on his/her own preconceptions. This must be explained further, but the article doesn't bother.

And how the heck do you give "placebo acupuncture?" Especially when many of its proponents (some of them here in this very forum) invoke the placebo effect when defending acupuncture against its skeptics? How, therefore, do we distinguish "placebo acupuncture" from "real" acupuncture?

Significantly, the article answers none of these questions.

Bully for Dr. Martin being convinced that something more than placebo is at work here. But this study is nothing more than an indication that, in the current absense of a compelling study, maybe we should perform a study.

Sorry if this sounds cynical or just too darned skeptical. But if the FDA approved a new drug that had been tested successfully on just 50 people, would you embrace it as the next miracle cure? Or would you say "I need stronger evidence than that" before making your determination?

I would hope that you'd pick the latter, in my example and yours.

First of all, naturally, this may not be the last word. I guess that is one thing you are saying, and of course I agree.

Second, would I try a new drug based on this? Of course not. New drugs, even approved ones, can have side effects or even kill. Acupuncture is virtually harmless. So, I would definitely try acupuncture based on this evidence, but would not try a new drug.

Acupuncture most likely works partially by placebo effect, and partially from another reason (as Dr. Martin believes, based on this evidence). There are ways to do placebo acupuncture, I think, but I personally would rather look at the overall effect of one treatment vs another. I realize that this would be a controlled study, but not a blinded one. But if people, say, in an acupuncture group feel better after treatment than people using some sort of other treatment, I wouldn't *care* if it was the placebo effect or not--I would just be concerned with the overall result. Best would be to influde follow up interviews several months later.

If even the proponents of acupuncture claim that part of its benefit is due to the placebo effect, then it becomes nearly impossible to do a test with any verifiable control. I mean, how could we go about it, really? "This one is the real placebo, and that one is the placebo placebo." You can see how this would present a difficulty.

I'm afraid that I'm not convinced by the "virtually harmless" claim, either. To date, acupuncture has been empirically documented to have no predictable, reliable effect, so any risk at all is too great when compared against the reasonable expectation of beneficial result. Contrast that with a drug that may have (for example) a one in 100,000 chance of damaging a heart valve, but for those other 99,999 it's been reliably demonstrated to yield dramatic beneficial results. The risk, though greater-per-incidence, is much less significant when weighed against predictable overall benefit.

For any medical procedure it is imperative that we set the bar higher than "doesn't cause harm." Any treatment worth calling a treatment must make a more solid positive claim than that.


Regardless, you make an excellent point in calling for follow up interviews. These are essential and are lacking from most testimonials about current alternative therapies, acupuncture included. That's why oncologists don't cut out a tumor and send the patient on her way--they perform rigorous follow-up over a period of months and years, and through such longitudinal studies we learn which treatments are more effective over the long haul. Without such longterm measures in place, the most that we can say about alternative therapies is that the customer left the office feeling somewhat better and may or may not have returned for follow-up care.

I also found acupuncture to be much more useful for acute pain than for chronic pain, but that's just me.

therapeutic effect as well in a "chronic condition characterized by fatigue, widespread pain in the muscles, ligaments and tendons, and multiple tender points — places on your body where slight pressure causes pain."

Almost anyone who has had a massage when their muscles are sore knows that it can relieve muscle pain; I haven't had acupuncture but others have told me it can relieve pain as well. Pain can cause you to hold your body abnormally which can cause additional muscle & joint pain.

There are some quite a few poorly controlled studies published looking at acupuncture, but I would expect the Mayo study to be done on a higher level. Since I can't read the article (it's in process at PubMed; link below), I don't know exactly how their placebo acupuncture was done, but usually it is done by touching the skin with the needle but not inserting it in the same way that is done in acupuncture. You should read more studies on acupuncture before rejecting any one study out of hand based on a few paragraphs in a summary article intended for a general, non-specialist reader. One wouldn't expect such a summary article to give in=depth detail about the procedure - the original article is the place to look for such detail.

50 patients, split between two groups, is not necessarily a tiny sample size - it all depends on the effect size of the treatment. The researchers probably began with a pilot study and ran a power analysis on those results to determine what size of sample should be adequate to provide statistically significant results. They then would run that size of a group and if the results weren't significant, they'd be out of luck. Additionally, no study is going to simply trust respondents to self-diagnose; it goes without saying (and will be detailed in the journal article) that the physicians themselves determined that the respondents indeed had fibromyalgia. This is standard in medical research.

One can certainly control for the degree to which an observed effect of treatment is due to the placebo effect: this is the purpose of the placebo group. If the placebo group shows some improvement, that is the "placebo effect". If the treatment group shows greater improvement than the placebo group, you can establish that while part of the treatment group's improvement is due to the placebo effect (as shown with the placebo group), since the improvement in the treatment group is greater than that for the placebo group, part of this improvement has to be due to the treatment administered. Of course, you run statistics, and depending on what kind of statistics you run and how stringent you are, you can say that with X% certainty (where X is usually between 95 and <100), your results are not due to chance.

Important for any study is the characteristics of the group being studied. One wouldn't expect the results of the study to extend beyond people who don't have approximately the same characteristics. Also, the treatment can be considered "effective" as long as it is effective in enough patients in the "treatment" group, compared to the "placebo" group, to give statistically significant results. In other words, an "effective" treatment does not have to work in everyone. If it's not, the next step is trying to characterize what factors might differentiate those in whom it works vs. those in whom it doesn't work (a lot of prescription drugs aren't effective in every patient - this is why doctors try one for a while and if it's not giving the desired results or has too many side effects, they try another. In medicine, the next giant step will be developing tests (blood, genetic, etc.) which will be more predictive about whether a medicine will work or not).

Finally, few physicians would advocate a therapy like acupuncture to be the sole treatment approach if there are proven drugs available precisely because there hasn't been much well designed research looking at acupuncture (but the body of well-designed studies in the literature is growing - well-designed studies require funding, which is only now becoming available, albeit in relatively tiny amounts). More likely they would approve acupuncture for an additional treatment method; acupuncture could, for example, reduce the amount of pain medication a patient requires.

The article isn't available yet at pubmed but here is the reference; you can also directly contact an author and ask for a copy of their article, although if you go to any major university library, they're likely to have (in=library for general public) access to the journal (you can call and ask):
Martin DP, Sletten CD, Williams BA, Berger IH.
Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial.
Mayo Clin Proc. 2006 Jun;81 (6) : 749-57.
PMID: 16770975

One can certainly control for the degree to which an observed effect of treatment is due to the placebo effect: this is the purpose of the placebo group.

That's true, of course, but if the underlying effect (i.e., the purported beneficial impact of acupuncture) is itself attributed to the placebo effect (as its proponents often do assert), then I have trouble imagining how we might screen for it. Any positive effect attributed to placebo would be claimed as a victory, thereby eliminating the falsifiability of the experiment.

I'd also like to mention that studies relying entirely on patient feedback rather than on objectively observable response would require much tighter controls. You correctly note that the size of the effect is important; I submit that the verifiability of the effect is also vital. What does it mean if several people out of a split group of 50 report a reduction of fatigue? Heck, what does it mean when someone says "I'm fatigued" in the first place? Lacking an objective or standard measure of such a variable, we need to be very cautious when attributing any beneficial effect to the mechanism being studies.

Yes, of course, pain and fatigue are inherently subjective phenomena, even in testing conventional drugs. That's one of the reasons that they test a new drug on more than 25 people--so that a standardized measure can be achieved.

So the basic objection remains: the sample size and verifiability of result are too small to be useful beyond a possible incentive to study the phenomenon further. The very nature of acupuncture is, at present, too nebulously defined to be falsifiable in any conclusive sense, so even an otherwise well-designed test will yield no valuable positive or negative result. The embrace of placebo effect as a possible driving mechanism for the efficacy of acupuncture demonstrates that a placebo-controlled study will likewise be nonfalsifiable and therefore of limited use.

I've mentioned before that the lack of funding for tests of acupuncture (or any other alternative therapy) may be true, but that's irrelevant. Such practices must be tested scientifically if they are to be given any credit for achieving the beneficial results attributed to them.

I happen to love the placebo effect, but this was a placebo controlled study. The results were such that the investigator said the effect was not due to the placebo effect. I know it sounds strange but there are ways to fake people out into thinking they have acupuncture when they actually don't. I have read about them but don't know the details right now.

Naturally, I would like to see more studies because then insurance will be more likely to cover acupuncture. Well, then it would get more expensive for those without insurance so I don't know if I am for that or not---

I am fortunate that I can keep my meridians balanced without getting actual acupuncture, and I am familiar enough with the points that I can do acupressure on myself. However the "rush" of getting acupuncture (flood of endorphins) is not present when I do acupressure on myself.

You know, acupuncture probably isn't for everybody, but I sure would recommend that anyone with almost any sort of health problem try it. My family has had a wide variety of things helped by acupuncture-- things that have no studies attached to them. If people are interested in reading studies before they have it done, that's fine too. They can use any information that they care to use before deciding on a medical treatment--studies, placebos, recommendations, etc. That applies to medications as well. I am not one to just take what the doctor says, because I feel they are often too heavily influenced by the latest pharma rep that visited their office. (If that marketing technique was not successful, it would be dropped.) And though medications must be proven and the studies are large and expensive, often the effect over and above the placebo is small and the possible side effects large (SSRIs generally fall in this category).

I happen to love the placebo effect, but this was a placebo controlled study. The results were such that the investigator said the effect was not due to the placebo effect.

That's fine, but you yourself have asserted that some portion of acupuncture's effect may in fact be due to placebo, so it's insufficient to say that the study was placebo-controlled. Since you're banking on placebo, you can't exactly remove it or control for it. And since you can't control for it, you can't claim it as validation. Heck, even if a beneficial effect is observed, the most you can say is that it may or may not be attributable to acupuncture. That's not much of an endorsement.

I know it sounds strange but there are ways to fake people out into thinking they have acupuncture when they actually don't. I have read about them but don't know the details right now.

If a participant in the study has only limited knowledge of acupuncture, it shouldn't be hard to perform a convincing placebo-fake, so that part doesn't bother me. What bothers me is the apparently deliberate blurring between placebo-as-test-control and placebo-as-essential-component of acupuncture.

I am fortunate that I can keep my meridians balanced without getting actual acupuncture, and I am familiar enough with the points that I can do acupressure on myself. However the "rush" of getting acupuncture (flood of endorphins) is not present when I do acupressure on myself.

Meridians as energy-pathways have not been shown to exist, so your statement can't be taken as anything more than testimonial. And the "rush" that you attribute to acupuncture-induced endorphin-flood has likewise not been confirmed beyond anecdotal evidence, so that's just testimonial, too.

You know, acupuncture probably isn't for everybody, but I sure would recommend that anyone with almost any sort of health problem try it. My family has had a wide variety of things helped by acupuncture-- things that have no studies attached to them.

Sorry, but that's just witnessing. Here's what you're saying: "Based on a miniscule sample-size with no experimental controls whatsoever, I have concluded that acupuncture has a beneficial effect on a range of health problems." That's a terribly reckless assertion.

I have never doubted your sincere belief in the practice, and I've come to accept that you really are arguing in good faith for a practice that you judge to be of great benefit. Unfortunately, your belief--even the belief of hundreds or thousands--is insufficient to confirm the practice as valid in the utter absence of hard, supporting evidence. You still have the right to sing its praises, of course, and people have the right to choose to undergo acupuncture, even in place of confirmed treatments.

But in themselves, testimonials don't mean that acupuncture works. Further study--no matter how inconvenient for proponents of acupuncture--is needed before anyone can credibly claim that it works. Until then, it is nothing but an intriguing but unproven practice.

And though medications must be proven and the studies are large and expensive, often the effect over and above the placebo is small and the possible side effects large (SSRIs generally fall in this category).


That's another dangerous claim. Countless drugs yield great benefit far in excess of any placebo effect--drugs for cancer treatment, malaria, diabetes, immune disorders, high blood pressure, and pretty much any antibiotic, for example. Sure, you can name a bunch of poster-child "bad drugs," but it's wildly irresponsible to dismiss drugs or the process by which their effects are tested.

I concede that my experience with acupuncture is anecdotal. I have never characterized it as anything other than that.

Well, obviously some of acupuncture effect is placebo--the same with drugs. BUT THIS PARTICULAR STUDY CONTROLLED FOR PLACEBO. In other words, the placebo effect was factored out, so it had efficacy above and beyond placebo. So I don't really understand your point here. If it is just to say that I agree that *some* of the effect of acupuncture is placebo, uh, okay. (???)

It isn't that I don't love placebo effect. It is just that this study had that controlled and something else was shown to be at work.

Yeah, I have a problem with my liver meridian being overcharged, and I have had to correct that maybe two or three times this week. If I was perfect in my eating habits, sleeping habits, and exercise habits that might not happen, I admit. (ANECDOTAL ANECDOTAL)

Oh sure some drugs are wildly effective. That is exactly why I say that people should evaluate the studies. I'm not against taking prescription drugs AT ALL when they are needed. What I am in favor of is people critically evaluating studies and their authors, and making their own decisions, based on whatever factors they choose, weighing risks and benefits and possible alternatives. In general doctors are busy and tend to hand out the "latest and greatest." I am suspicious of that. I am highly suspictious of SSRIs, which indeed have been shown to be effective in large, controlled studies, but margninally so, and with a rather large side effect profile, and high placebo response.

Well, obviously some of acupuncture effect is placebo--the same with drugs.

I would take issue with that. Can you name one drug in the entire range of modern western medicine that relies on the placebo effect as a central aspect of its function? Acupuncture, in stark contrast, relies heavily on placebo for its beneficial effect, such as it is.

BUT THIS PARTICULAR STUDY CONTROLLED FOR PLACEBO. In other words, the placebo effect was factored out, so it had efficacy above and beyond placebo.

In that case, we've reached a logical inconsistency. You say that acupuncture owes *some* of its beneficial effect to placebo, and yet this experiment eliminated placebo as an effect. If so, then the test eliminated part of the function of the technique being tested! As a result, the experiment isn't actually testing acupuncture anymore.

If the test happens to demonstrate a beneficial effect, then acupuncture's proponents will hail it as a victory; but if no beneficial effect is demonstrated, then acupuncture's proponents will claim that, since placebo was removed, then "full" acupuncture wasn't tested. This has happened numerous times with ESP and other so-called "psychic" phenomena, and it's simply a tactic (not necessarily a conscious one) seeking to render the testing process invalid.

So I don't really understand your point here. If it is just to say that I agree that *some* of the effect of acupuncture is placebo, uh, okay.

Consider this analogy: I want to test Tylennol's effectiveness in treating headache, but I remove the acetominiphen prior to administering the dosages. As such, I'm no longer testing Tylennol--I'm testing Tylennol-minus-an-essential-component. If it still treats headache effectively, then I'm apt to say that Tylennnol works! If it doesn't, then I can say "Oh, well, that's not real Tylennol anyway."

If *any* part of acupuncture is a result of placebo, then *any* test that controls for placebo isn't testing acupuncture. I don't know how to make it any clearer.

Look at it this way--

Assume--

1. One group gets *fake* acupuncture (this is the placebo effect alone)

2. One group gets *real* acupuncture (this is the placebo effect plus the effect that is not the placebo)

3. Both groups do significantly better than no treatment. This proves that the fake acupuncture is more effective than nothing, and the real acupuncture is more effective than nothing. This does not prove that the real acupuncture is better than the fake acupuncture or that the effects of acupuncture due to anything other than placebo.

4. *Real* acupuncture group gets statistically significantly greater efficacy than *fake* acupuncture group. This proves that the positive effects of acupuncture cannot be solely attributed to the placebo effect. There is something else at work. Since in this case, the real acupuncture got better results than the fake acupuncture, there is something other than placebo that is causing acupuncture to be effective in this case.

What part of this don't you understand?

Bedilia?
Hunt?
Lies over the Ocean?
Huh?

1. One group gets *fake* acupuncture (this is the placebo effect alone)

2. One group gets *real* acupuncture (this is the placebo effect plus the effect that is not the placebo)

3. Both groups do significantly better than no treatment. This proves that the fake acupuncture is more effective than nothing, and the real acupuncture is more effective than nothing. This does not prove that the real acupuncture is better than the fake acupuncture or that the effects of acupuncture due to anything other than placebo.

4. *Real* acupuncture group gets statistically significantly greater efficacy than *fake* acupuncture group. This proves that the positive effects of acupuncture cannot be solely attributed to the placebo effect. There is something else at work. Since in this case, the real acupuncture got better results than the fake acupuncture, there is something other than placebo that is causing acupuncture to be effective in this case.

Hey, that's pretty clever. I'm embarrassed that I didn't see it before, but I think that you've formulated a pretty nice test. Thanks!

But you make a significant point in Assumption 4:
Since in this case, the real acupuncture got better results than the fake acupuncture, there is something other than placebo that is causing acupuncture to be effective in this case.

I don't see that in the original article, so even though your hypothetical test addresses it, Dr. Martin's apparently doesn't. I see that he concludes that "there is something more than the placebo effect to acupuncture," but the article doesn't support that. The article doesn't even mention that placebo was controlled for. If that's borne out by the text of the study itself, then that's super, but we'd need to see it before we can credit it.

And then we still have the too-small sample size, and other methodological questions remain, too.

But thanks for providing a hypothetical study--that's quite helpful! :hi:

But that is what I thought he meant all along.

It is Bonnie as in lies over the ocean!! Great song!!