LE and accupuncture: the Sloan Kettering study appears flawed

kira66715

http://scienceblogs.com/insolence/2013/07/02/acupuncture-and-breast-cancer-related-lymphedema-quackademia-strikes-again/

It's a long post, but the bottom line is it was an uncontrolled study, and women could still use their usual LE treatments, so it's not truly controlled to look for benefit

Acupuncture and breast cancer-related lymphedema: Quackademia strikes again

Posted by Orac on July 2, 2013

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Lymphedema is a complication of breast cancer surgery that all surgeons who do breast surgery detest. Patients, of course, detest it even more. The limb swelling that is the primary symptom of lymphedema comes about because surgery on the axillary lymph nodes (the lymph nodes under the arm) that is part and parcel of surgery for breast cancer can interrupt lymph vessels and cause backup of lymph fluid in the affected arm. This backup has consequences, including skin changes, a tendency towards infections, and, in extreme cases, elephantiasis (which is, fortunately, rarely seen these days as a result of breast cancer surgery). Unfortunately, lymphedema is incurable, and the risk of developing it never goes away after breast surgery.

Lymphedema used to be much more of a problem back in the old days (say, more than 10-15 years ago), when surgery for breast cancer routinely involved an axillary dissection, or removal of most of the lymph nodes under the arm. (For surgery geeks, in breast surgery level 1 and 2 lymph nodes out of three levels, unless, of course, leven 3 nodes are grossly involved with tumor, in which case they’re taken too.) Frequently radiation therapy was needed as well, and the combination of axillary dissection and radiation therapy could produce a risk of lymphedema as high as 50%. Of course, in recent years, sentinel lymph node biopsy, which involves removing many fewer nodes (usually 1-3) has supplanted axillary dissection for most cases of breast cancer, and, consistent with fewer nodes being taken, the risk of lymphedema from sentinel lymph node biopsy is much lower. However, none of this means that lymphedema isn’t still a problem after breast surgery; it’s just less of a problem.

There are only a few basic strategies for treating lymphedema, sometimes called decongestive lymphatic therapy. For the most part, these treatments involve physical therapy, compression sleeves to “squeeze” the fluid out of the affected limb, and sometimes the use of mechanical compression stockings that “milk” the fluid back. It’s all very inconvenient and unpleasant, and there’s no doubt that this particular complication can take a major toll on a patient’s quality of life and sometimes even lead to hospitalizations for infection. It might be less of a problem than it was in years past, thanks to less invasive surgery, but it’s still a problem, and it needs better treatments.

Acupuncture is not one of them.

Not that proponents of acupuncture don’t try to convince people that acupuncture is a treatment for lymphedema. To be honest, knowing the mechanism by which lymphedema develops, I can never quite figure out why anyone would think that acupuncture would do anything for lymphedema. How, pray tell, would sticking needles into the body, often in areas of the body not involved by lymphedema, be expected to cause lymphedema to get better? Yet, acupuncturists keep claiming that acupuncture can be used to effectively treat lymphedema. Indeed, if there’s one image that causes me to cringe when I see it, it’s the image of needles being stuck into a lymphedematous arm, often with the acupuncturist not wearing gloves. In any case, just yesterday there appeared news of the publication of a study out of Memorial Sloan-Kettering Cancer Center (MSKCC) examining acupuncture as a treatment for breast cancer surgery-associated lymphedema in the ASCO Post:

Arm lymphedema affects approximately 30% of breast cancer survivors, with rates increasing with longer follow-up and cases presenting well beyond the active treatment period. Lymphedema is observed even with use of less-invasive surgical techniques for staging, and risk is further increased by such factors as radiation therapy, positive lymph node status, increased tumor burden, postoperative seroma or infection, obesity, and increased age. Current treatments for lymphedema after breast cancer treatment are expensive and require ongoing intervention. As reported by Barrie R. Cassileth, MS, PhD, of the Integrative Medicine Service at Memorial Sloan-Kettering Cancer Center and colleagues in Cancer, acupuncture may be an effective treatment.

The study appeared in the journal Cancer and was entitled Acupuncture in the treatment of upper-limb lymphedema: Results of a pilot study. It’s as fine an example of quackademia as I’ve ever seen, its lead investigator being our old friend Barrie Cassileth, the director of the integrative medicine department at MSKCC. Just put her name in the search box of this blog, and you’ll see that, although Dr. Cassileth is very much against cancer quackery like laetrile, shark cartilage, Entelev/Cantron, various oxygen therapies (such as hyperbaric oxygen or various means of administering hydrogen peroxide), and even “energy therapies,” which Cassileth admits have no evidence to support them. Of course, acupuncture is an “energy therapy.” It does, after all, postulate that inserting fine needles into pathways in the body called “meridians” somehow alters the flow of magical, mystical life force energy known as qi, to curative intent. Yet Cassileth really loves acupuncture, so much so that she’s conducted quite a few studies on acupuncture in cancer patients. For example, there was this one on acupuncture for hot flashes a few years ago.

So this time around, it’s acupuncture for lymphedema. Truly, acupuncture is the therapy that can do anything, which is consistent with its being quackery. Certainly, no one has ever postulated a mechanism by which acupuncture can do all the things claimed for it, including (but not limited to) relieving pain, relieving hot flashes, treating infertility, improving asthma symptoms, and, of course, treating lymphedema. What’s the common unifying biological mechanism that could explain therapeutic effects in all these diseases and conditions? There is none, at least none that any acupuncturist has ever been able to explain convincingly to me, nor was any claimed in the ClinicalTrials.gov entry for this.

So what does this study purport to show? It’s a pilot study involving 33 patients with breast cancer-related lymphedema for at least six months but not longer than five years. This time period was chosen to make sure that the subjects were all out of the immediate postoperative period but not so many years out that they started to develop skin complications from chronic lymphedema. These patients all underwent twice weekly 30 minute acupuncture sessions for four weeks as follows:

Alcohol swabs were applied prior to insertion of sterile single-use filiform needles (32-36 gauge; 30-40 mm in length, Tai Chi brand, made in China and distributed by Lhasa OMS, Weymouth, MA) that penetrate 5-10 mm into the skin. A total of 14 needles were inserted: 4 in both affected and unaffected limbs, 2 in acupuncture points on both legs, and 2 in unilateral points on the torso. Selected acupuncture points (Fig. 1) were stimulated manually by gentle rotation of the needles with lift and thrust. The acupuncturists did not intentionally seek to achieve a de qi sensation.

Specific acupuncture points used in this study were determined on the basis of historical context, the published literature, and the consensus of our experienced group of MSKCC staff acupuncturists.[18-20, 34, 37] Many of these acupoints are used to treat pain, weakness, and motor impairment; others are traditionally used to drain “dampness,” a TCM concept similar to edema.

Did I just read what I thought I read? Seriously? The rationale for choosing these points was based on their being related to traditional Chinese medicine concepts to drain “dampness”? This is utter nonsense, the sort of silliness in which quackademic medicine corrupts academic medicine with concepts that have nothing to do with science. Just read about “dampness” in TCM:

In nature, dampness soaks the ground and everything that comes in contact with it, and stagnation results. Once something becomes damp, it can take a long time for it to dry out again, especially in wet weather. The yin pathogenic influence of dampness has similar qualities: It is persistent and heavy, and it can be difficult to resolve. A person who spends a lot of time in the rain, lives in a damp environment, or sleeps on the ground may be susceptible to external dampness.

Similarly, a person who eats large amounts of ice cream, cold foods and drinks, greasy foods, and sweets is prone to imbalances of internal dampness. Dampness has both tangible and intangible aspects. Tangible dampness includes phlegm, edema (fluid retention), and discharges. Intangible dampness includes a person’s subjective feelings of heaviness and dizziness. A “slippery” pulse and a greasy tongue coating usually accompany both types of dampness. In general, symptoms of dampness in the body include water retention, swelling, feelings of heaviness, coughing or vomiting phlegm, and skin rashes that ooze or are crusty (as in eczema).

As I said, none of this has anything to do with science.

So, based on a TCM concept of “dampness” being tortuously related to lymphedema, quackademics at MSKCC subjected patients to acupuncture and measured their limb circumferences. There are a few ways to measure lymphedema. One is water displacement, in which the subject puts her arm into a cylinder of water, and the volume displaced is measured. This method isn’t used much anymore because it’s messy and inconvenient to do, although it is arguably the most accurate. In most cases, lymphedema is measured by comparing the circumference of each arm at different locations defined by anatomy. Generally, this is done in four locations, the metacarpal-phalangeal joints, the wrist, 10 cm distal to the lateral epicondyles, and 15 cm proximal to the lateral epicondyles. Differences of 2 cm or more at any point compared with the contralateral arm are considered by some experts to be clinically significant. The authors used a two-point technique performed by trained research assistants 10 cm above (upper arm) and 5 cm below (lower arm) the olecranon process using nonstretch tape measures, which is said to be as sensitive and specific as any other methods. The median age of subjects was 55, and they were a mean of 3.9 years out from surgery. They were on the obese side, with a mean BMI of 30.4, which is above 30 and thus in the obese range.

The results were as follows. A 30% or greater decrease in arm circumference was observed in 11 patients (33%) and 18 had a reduction of at least 20%, a reduction reported to be across the whole range of severity of lymphedema. One notes that 31 subjects (94%) used other standard therapies during the study, although 30 reported no change in their standard regimen. Now here’s where how you present the data makes all the difference in the word. These percentages seem huge, but you have to remember that the way they were calculated was in terms of the difference between the two arms in circumference, normalized to the pre-treatment difference. If the pre-treatment difference is small, then it doesn’t take much of a decrease in lymphedema to produce a large percentage. That’s why the really telling figure comes from Table 3, which shows that the mean difference between pre-treatment and post-treatment arm circumference was 0.9 cm (95% confidence interval 0.72 to 1.07 cm). That is spectacularly unimpressive, particularly in a population that skews obese. It sure sounds a hell of a lot more impressive.

Of course, the biggest problem with this pilot study is that it was uncontrolled. There is no control group. So we have no idea whether acupuncture had anything to do with the modest decrease in lymphedema reported. I will give Dr. Cassileth credit in that she does acknowledge this in the paper:

Whether acupuncture alone was responsible for this reduction was not evaluable in this pilot study. Our focus was on safety and potential efficacy, as current clinical practice to protect the lymphedematous arm prohibits needling.

Yet she also concludes, unfortunately:

The therapeutic and cost-reduction potential of acupuncture for lymphedema may yield an important tool in the arsenal of lymphedema management. Although randomized clinical trial results await, including our ongoing study, acupuncture can be considered to treat this distressing problem confronted by many women with no other options for sustained reduction in arm circumference.

And in a press release, she says:

“We have shown that acupuncture as a treatment for lymphedema is safe and well tolerated,” says Dr. Cassileth. “Furthermore, this study demonstrated reductions in lymphedema for the patients treated, providing strong impetus for the randomized controlled trial that is now under way to prove that the effect is real.”

Actually, no it doesn’t. This study is not good evidence that acupuncture works for lymphedema. There is no reason from a standpoint of prior plausibility informed by biology to think that acupuncture would do anything for lymphedema. On a Bayesian basis, exceedingly low prior probability plus an equivocal result (and, yes, this result is equivocal) equals a very high likelihood that the effect observed is a false positive. Even worse, the randomized clinical trial being carried out isn’t one that is likely to provide much of an answer. It’s a phase 2 clinical trial comparing immediate acupuncture to wait list for six weeks, after which wait listed subjects will cross over and receive acupuncture for six weeks. In other words, everyone in the study will receive acupuncture. I mean, really. Why are they even bothering? This study is unlikely to provide strong evidence that acupuncture works. Most likely, it will be another equivocal acupuncture trial. Of course, the ironic thing is that the crossover design was probably necessitated by the seemingly “positive” result of Cassileth’s currently reported trial. The IRB probably wouldn’t approve a no acupuncture arm in light of that, because then there wouldn’t be clinical equipoise.

Oh, the ironies of quackademic medicine, when the inevitable false positives that occur when treatments of low prior probability are tested in clinical trials complicate the next steps! It’s just infuriating how much time and resources are being wasted on studies that are so highly unlikely ever to produce useful results.

 

Anonymous

Not sure where your dialog starts Kira, and quackademia? LOL I love it. Might have to borrow that one. I've only skimmed through. ( I want to avoid getting seriously angry and I have a feeling reading it in full might do just that )

Why Oh why Oh WHY would ANYBODY even consider putting needles into an arm with LE? It's pretty conclusive that we all agree needles are a no no right? Same with scratches, bites, in fact any skin break. It's a no brainer. What then, gives acupuncture a pass to violate this simple principle? Buyer beware!

Thanks for the headsup.

Marple

Kira, as always, you provide us with really useful information. 

Binney4

Hmmm, Orac is not too impressed, is he? Kira, thank you. I enjoyed reading this, though I'm ticked about the sloppy research. There is such a crying need for real research into LE options, and sometimes what gets funded takes my breath away.

And anyway, it would have been nice if it had been a study we could have learned from. Sigh!
Binney

kira66715

Musical, I just wrote the first line and did some bolding.

It would be funny if it wasn't just so sad. But, I need to reread it as well to help remind me of how bad studies produce bad results: garbage in: garbage out.

Binney found this in the comments section: it's not bad, but doesn't mention breast/truncal LE, and under estimates the prevelance,IMO

http://www2.mskcc.org/patient_education/_assets/downloads-english/20.pdf

Anonymous

"garbage in: garbage out."

+1 +1 +1. Another one of my favourite sayings because its based on the truth.

cookiegal

hi....

OK I don't disagree with a lot of what's written.

I know the acupuncturist who did the study, he is a good guy who was helpful to me when I was almost disabled by pain. I did not do the study, I think my LE developed a bit later. That being said I did have a bunch of injections in my LE arm through an osteopath, and while it did not cure my LE it did improve it. I think it treated muscle problems more than anything. I do agree the controls are a mess. I actually suspect the patients were more compliant with their LE treatments during the study. I know when I was getting all those injections I wore my sleeve a lot to prevent swelling .

kira66715

Cookie, it's so hard to generate good research, especially with CAM.

This study was sent out by Solaris as part of their newsletter and when I shared the critique, they were ashamed, but they're not scientists who are trained to evaluate the quality of data and study design.

The laser people still tout their absolutely horrible studies.

And worse, IMO, the NLN based their recommendations on compression and flying on a study that is far, far worse than this: one surgeon "thought" about his patients. Seriously, didn't examine them, just asked if they flew and if they swelled and if they wore compression. This is science??? This is the data that they cling to to withdraw their endorsement of consideration of compression in air flight for at risk women???

The risk of "evidence based medicine" is lack of data, poor quality data and this is a great New Yorker article on how data is often not reproducible: The Truth Wears Off

http://www.newyorker.com/reporting/2010/12/13/101213fa_fact_lehrer

As special irony: when the NLN based their recommendations on garbage studies, I emailed them and got an amazingly hostile reply, and one of the people who authored that nasty response had shared this article widely. I had the head of Vodder backing me up, and they simply would not accept any questioning from someone who wasn't on their MAC. (Medical advisory board). And one of the respondents had used a piece of writing from SUSO in her lectures....I've given up dealing with the NLN, they're ossified, IMO and treat patients like second class citizens.

So off topic.

Glad he helped you Cookie.

I once read a wonderful editorial about psychiatric research and how so many patients improved from the TLC that they received from being in a study that it was hard for the active drug to significantly be better than placebo.

Can't discount the healing power of being treated and acknowledged.

cookiegal

Another factor, these folks were coming into sloan's complimentary center twice a week where there happen to be special workout classes, meditation classes, oncology massage and so forth. I kinda suspect some of them probably had some wholistic benefit from that. Again hard to separate from the acupuncture. we also don't know if they had better access to MSK's overwhelmed LE program.



On the bright side this particular practitioner is interested in helping women with LE.

Binney4

Bumping for dlb. Happy weekend, everyone!
Binney

Brooklyn1234

Hi everyone,

I agree that this was a pretty shoddy study. But my problem with Orac's writeup is that he clearly thinks acupuncture is a bunch of junk. The first is fact. The second is opinion. I found it frustrating and unhelpful the way fact and opinion were interwoven throughout his piece. When Westerners know nothing about Eastern medicine, we tend to ridicule concepts such as 'dampness.' They seem absurd to us. But when we start to learn a bit, we realize that these are best understood as metaphors. Much more can be said on this topic, but for now I'll leave it at that.

I didn't qualify for the Sloan Kettering study, but I obtained the protocol and went to a community clinic, where they administered the points on me. My therapists said that this was a basic anti-inflammatory protocol that included some local drainage. We all now know that inflammation is thought to be deeply connected to LE. I didn't go consistently, but I did find that sometimes I would walk out of the clinic with my arm completely drained and feeling wonderful -- better than a good swim or an MLD session. That's my experience. Sometimes I let them needle my LE arm and sometimes I didn't. In my case and in the case of those women in the Sloan study, we should keep in mind that there is absolutely no evidence that anybody's LE got worse due to the needling. I know that NYU has been doing a laser study for LE. I'm grateful that are institutions and people out there willing to at least try new approaches. We badly need that. 

I once talked to the LE researcher Stanley Rockson, and he basically said so little is known about LE right now that any question you can ask is a valid one. I would like to think that something similar is true for the experimentation out there. We all know that doctors don't treat LE, they cause it. So patients like us  and a small handful of therapists and researchers are left to conduct our own experiments. We need as much feedback as we can get. In my case, compression and MLD are absolutely not satisfactory answers. I desperately need the LE community to keep trying new things and reporting back. Yes, flaws in studies should be discussed. But to my mind, a flawed study doesn't mean acupuncture is quackery. For those who are interested, take a look at all the research going on now about acupuncture at major Western universities. If we're going to raise objections to a study, let's make sure we're being as objective and careful as possible. I know everybody is on here with the very best intentions and to help each other, and I appreciate this forum very much, especially the regular contributors like Binney and Kira. Thank you!  

kira66715

Brooklyn, I just finished the Paul Offit book : "Do you believe in magic?", where he attacks most complementary medicine. He is a compelling writer and I found myself initially very swayed by his arguments, but then I realized he cited studies and not really the results--like a 17% increase of death with some vitamins--not impressive and how long did they follow patients.

He dismissed acupuncture out of hand, because it was developed so long ago, and on flawed premise, per him.

I think that complementary medicine has benefits, and that there are hucksters out there, like Dr. Oz and Andrew Weil who don't look at the science and try to sell things, and that the studies of CAM tend to be flawed, unfortunately.

I took gigong and did Tai Chi in the first year after my surgery, and found it very helpful. I've found acupunture to be operator dependent.

I think we need to protect ourselves against harm with complementary medicine, but also look at why it's so popular and why it feels so great to go into a quiet room where someone touches you gently and with the intent to heal.

So, I did toss out some vitamins after reading the Offit book, and talked to my LE therapist today---who is a firm believer in acupuncture and supplements--and she just would use the meridians and not put the needles in the quadrant.

I once heard a lecture by Andrea Cheville MD of Mayo Clinic, who is trained in acupuncture, and she tried it on her patients, and wasn't impressed with the results. She never did a formal study that I know of.

My parents belong to Kaiser Permanente in California, and acupuncture is offered at the medical center for back pain.

I totally agree with you that we should keep an open mind, avoid the polarity that is developing and there's lousy science in a lot of studies, not just CAM.

Thanks for such a thoughtful post.

my2boys

Just adding my two cents here. I have been going for acupuncture for my lymphedema for one year and it has improved somewhat. My acupuncturist is using the Sloan study and replicating most of the points except for the one point directly on the LE arm. He does, however, do the points on the shoulder of the LE arm. My swelling has improved slightly and he also seems to be helping with the scar tissue. I noticed an increase in symptoms over the summer when I didn't visit my acupuncturist as much (maybe only 2 or 3 times) and ever since I started up going regularly again, I am showing improvement again. Acupuncture isn't for everyone, but it really helps! The key is finding a good acupuncturist.

I have always worn garments and done manual massages every day and I have continued with those as well, so I use acupuncture in addition to regular care, not instead of regular care.



One additional note....my knee was bothering me for months and acupuncture helped tremendously with this. Apparently, it reduces swelling. My stress level is greatly improved too!

duckyb1

Swear by acupuncture, but you need the best......I have a Chinese Dr who graduated from the University of Shanghi, and she is amazing.......would not go to just anyone......would go every week if I could afford it......she gives me a senior rate...$45.00 per 1 hour treatment, and that includes the accupuncture, cupping, and hot stone massage ..........she is a genius when it comes to relieving pain.....however.....no one puts needles in my LE arm, and when I asked about acupuncture.

for LE she said a big NO.

purple32

NY CLINICAL TRIAL

I have had acupuncture in the past  when I broke my knee 8 yrs ago- FAB. results!

Had it last yr for frozen shoulder  (NOT in LE arm thank you!) and while the shoulder has improved , I do NOT attribute it to acupuncture.  Time and stretching is my belief,  During the 6 weeks I went to ACU.  all I had was GREAT relaxation but NO difference in the shoulder... nada.

I have taken taichi and qigong and love them, but NO help with lE.

Having said that, the dr I went to 8 yrs ago (knee) was a PCP who also did acupuncture<moved from this area<  I do wonder about each individual practicioner.

This may be of interest to some, ESP in New York :
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pip57

I had acupuncture for severe degenerative disc disease in my neck.  The associated pain was in my affected arm.  I was quite nervous about having needles in that arm but nothing else was working.  The results were amazing.  It is not "quackery".   

I agree that it is totally dependent on the person doing the acupuncture. I would never consider someone who wasn't properly trained in the Chinese method.   Too many in North America are sports therapist grads who took no more than a few weeks training in acupuncture.   

juneping

about acupuncture, I asked mine (not for LE) and his staffs told me traditionally acupuncture was passed inside the family only. To male not female. 

But the skill of the doc is the most important thing. My primary doc who is a westerner and knows acupuncture but I would trust my Chinese doc who I use instead of my primary doc. May be I am bias but I rather have someone knows. He started practicing/learning with the guidance of his father at 7 or something....sorry can't remenber how old exactly. But it's just very young. And he's good. Geez the line in his office is long....

purple32

d hot stone massage ..

I miss that !  Quite a NO NO with LE, isn't it ?