Stem Cell Enhancers?

This morning I was at the Ethical Society with Flimsy, giving a presentation on the book Evidence of the Afterlife. Our presentation went well, and afterwards I was approached by a nice woman who I have seen occasionally at book clubs and other skeptical events. She told me about this revolutionary new group of products called StemEnhance, StemFLO, and StemSPORT can cure a bunch of diseases and is being produced by a Nobel Prizewinner.

I listened intently, but admitted that I was skeptical of the claims she was making. She handed me a sheet of paper with information and some pamphlets, which I promised to research further.

StemEnhance is purported to be a "natural stem cell enhancer", taking advantage of the media hype over the ability of stem cells to renew themselves and differentiate into different specialized cell types. The company claims that its products (which are marketed for humans and pets) is:

The world's first-ever natural stem cell enhancer… the only nutritional supplement in the world proven to support the natural release of your own adult stem cells from your bone marrow! StemEnhance consists of a patented natural 5:1 concentrate of an edible aquatic botanical known as Aphanizomenon Flos-aquae (AFA for short) that contains two proprietary components, Migratose and Mobilin. AFA grows in a unique, pristine environment in the northwestern United States and it has been safely consumed for over three decades.

The whole idea behind taking green algae pills to enhance stem cell circulation is due to speculation by the creators of StemEhance that adult stem cells can repair organs and tissues by "migrating" around the body to various locations. My acquaintance told me excitedly that the makers of this product won the Nobel Prize in 2008 for their work, but unfortunately I think she was given bogus information. The information she gave me read:

"Stem cells are immortal. The problem is detaching from bone marrow and attaching to the damaged organ. The 2008 Nobel Prizewinner irradiated stem cells turning them green and let them repair muscle."

The Nobel Prize in Chemistry for 2008 was awarded to Osamu Shimomura, of the Marine Biological Laboratory and Boston University Medical School, Martin Chalfie of Columbia University, and Roger Y. Tsien of the University of California, San Diego "for the discovery and development of the green fluorescent protein, GFP." The green fluorescent protein was important not because it could "repair muscle" but because it glowed and thus could be used to watch previously invisible biological processes and has aided in stem cell research. The 2008 Nobel Prize in Medicine was awarded to researchers who discovered HIV.

So let's see if this research [1] is as impressive as it sounds, shall we? The research article in question is unfortunately not available to the public, but I took it upon myself to track it down so that I could read it. The study consisted of an in-vitro (test tube) and in-vivo (in the body, with real human subjects) test. In-vivo test consisted of twelve subjects who consumed either StemEnhance or a placebo, had their blood drawn at 30, 60 and 120 minutes after consumption while sitting quietly. The study did not explain how the subjects were blinded, but did describe the placebo pills as looking identical to the StemEnhance pills and being made of dyed potato flakes. The study also did not explain how the researchers were blinded. The researchers tested the blood samples by looking for 6 different markers of stem cells. One of those markers was called CD34⁺.

The results were that "only the analysis of CD34⁺ showed a significant difference upon consumption of StemEnhance… ingestion of StemEnhance resulted in an 18±3% increase in the number of circulating CD34⁺ cells, maximizing at 60 min after ingestion… Questionaired completed by the colunteers on every experimental day revealed that three of the colunteers met criteria for exclusion (e.g., significant lack of sleep, severe anxiety) on at least one experimental say. Exclusion of these volunteers in the analysis resulted in a 25±1% increase in the number of circulating stem cells."

So, their analysis is based on 9 subjects. That is barely enough for a pilot study, especially for substances taken internally. Additionally, the CD34⁺ marker tested for hematopoietic stem cells – cells that can become blood cells but not other types of tissue cells. There is more important information missing from this paper: How were the subjects distributed into placebo and StemEnhance groups? Was the split even, with 6 in the placebo group and 6 in the StemEnhance group? Of the three participants that were excluded, from which groups did they come? This information is essential to research papers. Additionally, the authors say that the difference was significant, but they do not give the actual numbers. They also do not address effect size, which is also essential to research. Giving the effect sizes would allow readers to determine if the differences in these two groups are large enough to detect a real phenomenon. Their P value was set at P<0.05, which is acceptable for preliminary pilot studies. This value is unacceptable for establishing anything beyond that there may be an effect. More rigorous studies are needed to establish if there really is a real effect, and further rigor is needed to establish if that effect is clinically relevant. This product, therefore, is no breakthrough as the pamphlets would suggest.

I am unimpressed by this research. It lacks rigor and transparency found in reputable research. The increase in CD34⁺ is tiny. As another blogger put it:

OK, the extract treatment shows an increase CD34+ cells. A whopping increase from 0.062% to 0.085% (which of course is billed as a 30% increase). Now take a look at the placebo treatment. No increase, just as they claim, but the initial percentage of circulating CD34+ cells is already as high as AFTER StemEnhance treatment. Can anything meaningful be taken from this result? If you continue to read the paper, you'll find that the increase is quite transient, peaking after 60 minutes but lasting no more than 2 hours and that the effect in one person on 16 different test days can vary wildly (from a 300% increase in CD34+ to a 4% decrease).

So this study shows a teeny tiny, but statistically significant increase in circulating stem cells for about an hour after you swallow algae pills. The stem cell circulation then returns to normal. Will this increase in stem cell circulation offer miracle cures? Will consuming fresh clover cure heart disease? There is no evidence of either. Additionally, the researchers in the study (Jenson and Drapeau) are the same people who created and market this product, which means there is a serious, damning conflict of interest.

The chief science officer and brainchild of the company, Christian Drapeau, estimates that the company has sold 425,000 bottles from November 2005 to May 2007 and sells approximately 50,000 bottles per month. At $60 a bottle, that amounts to 25 million dollars of algae pills sold in 2 years and $300,000 in product sales a month. If the product sales have held steady since 2007, that means that they've sold over one hundred million dollars worth of product. That's a pretty substantial conflict of interest. That's over one hundred million dollars worth of product that has not been proven to help people, ever. There is no evidence that this product is safe or that it will improve one's health. In fact, if the product really does what it claims to do, it could "activate dormant cancer cells" according to Kerry Grens at The Scientist. Drapeau is also the former director for R&D at Cell Tech International, another algae company that was sued for making deceptive claims and false advertising. They lost the suit.

Part of StemTech's success at hawking algae pills is their business structure. They operate using a Multi-Level Marketing structure. Multi-Level Marketing, or MLM is similar to a pyramid scheme, and such business models have been subject to criticism and lawsuits. I probably don't need to explain why MLM's are bad news, but if you need more information you can always check out the website MLM watch.

It makes me angry that such a nice lady has been victimized by this company's MLM dubiousness. It bothers me that people can make claims about miracle cures without proving it first. There is no such proof from the makers of this product. My acquaintance was very excited about this product and told me about how there might be some good business opportunities for me if I were to be interested in the product. This is probably not the answer that she wants to hear, though.

[1] Jensen GS, Hart AN, Zaske LA, Drapeau C, Gupta N, Schaeffer DJ, Cruickshank JA. Mobilization of human CD34+ CD133+ and CD34+ CD133(-) stem cells in vivo by consumption of an extract from Aphanizomenon flos-aquae--related to modulation of CXCR4 expression by an L-selectin ligand?  Cardiovasc Revasc Med 2007:8;189-202

Sex-offender chiropractors

Can someone please explain to me why registered sex offenders can practice (with limitations) as chiropractors, but physicians cannot?

Reader Miss Lou sent me this interesting article, saying, "Apparently if you are a sex offender in Minnesota, the state law says you can't be a physician but you can be a chiropractor. He doesn't even have to tell his patients!"

The long and the short of the article is that a chiropractor who engaged in egregious sex offenses on the clock, while practicing his trade, went to prison for 2 years, had his license revoked for 6 years, but was granted his license again – with limitations – so that he may continue to practice as a chiropractor.

This month, more than six years after revoking Fredin's license for the felony convictions, the state Board of Chiropractic Examiners granted Fredin's request to get his license back. To protect Fredin's clients, the board said he cannot treat any female patients without someone else in the room. Fredin is working in Minneapolis, but he can't treat patients until regulators approve his new location.

Why do I care? Well, because it seems that the regulations for chiropractors regarding registered sex offenders is much more lax then that of physicians and other medical care providers.

Under state law, many professionals -- including dentists, psychologists and nurses -- can't be barred from practicing after a criminal conviction as long as they can show licensing boards they were rehabilitated.

I wish I had a complete list of those who can't be barred.

However, there are no second chances at the state Board of Medical Practice, which regulates 22,000 health-care providers, including physicians, midwives and acupuncturists. In 1995, the Legislature passed a law requiring the board to yank the medical license of anyone convicted of a felony-level sexual offense.

Personally, I think that the standards of practice for chiropractic ought to be the same as the standards for any other medical profession. While I would contend that chiropractic is medicine, the field of chiropractic certainly acts like and in many cases is treated as such. I also wonder if these standards are limited to Minnesota or if one can find lax sex-offender standards for "medical" professionals in other states. Ah, to do research…

I get email: homeopath

Today this email appeared in my inbox:

Respected Madam,

(I hope that you are the same person who did sleeping pill experiment)

The otherday, I watched the video of your experiment on homeopathic sleeping pills.

First of all, let me appreciate you for your interest in the evidence based medicine. As per the experiment done by you, the homeopathic sleeping pills can't induce sleep in a humanbeing. I fully agree with you. But, let me tell you the truth that, there are several patent preparations (combinations) marketed as homeopathic medicines. These are actually not homeopathic as per the principles of homoeopathy. The genuine homoeopathic medicines are totally different from these combinations and mixtures. Let me tell you the truth that, homoeopathy has suffered a lot from these non homoeopathic medicines.

A medicine becomes homoeopathic when it is selected on the basis of homoeopathic principles. Recently one scientist in India took a homoeopathic medicine and reported that the medicines could not produce any symptoms on him. This clearly proves that he was not susceptible to the medicine he had taken. If a group of people take the same homoeopathic medicine, only a small percentage of them will have the symptoms and others will not respond immediately. On the other hand, taking the same medicine repeatedly on regular interval can produce the symptoms in many, but here also a few will not be affected.

we can classify homoeopathy in to classical and modern homoeopathy. The classical homeopathy is the genuine one and the other is just an imitation of modern medicine, ie, suppresing the presenting complaints of the patient.

I am practicing homoeopathy since 8 years. Initially, my results were not satisfactory. But, after learning the real homoeopathy by joining BHMS (Bachelor of homoeopathic medicine and surgery), my results are excellent. Now I get different varieties of cases including the failed cases coming from the hands of modern medicine.

While going through your experiment, I feel that, instead of taking a "homoeopathic" patent preparation, you could have taken a genuine homoeopathic medicine for the experiment. The other option is (which will be the best and easy method for you), you notedown your own symptoms in detail and take a suitable homoeopathic medicine from a trained homoeopath or a group of homoeopaths. I am sure that this will prove the efficacy of homoeopathy.

After watching your video, many homoeopaths might have called you as skeptic or a critic funded by some allopathic drug manufacturing company. But, I am not in that category. I feel, if you experiment homoeopathy in a proper way, you will become the ambassador of this system; because most of the famous homoeopaths were once had critical attitude towards the same.

Eagerly waiting to get feedback from you.

Kind Regards.

Dr Muhammed Rafeeque, BHMS, PGNAHI.

Family Homoeopathic clinic

Kerala

India.

www.familyhomoeopathy.com

Dragon's Den ownage.

Here is an entertaining video in which the guys of Dragon's Den completely smash to smithereens all hope that this snake-oil salesman had of hawking his bullshit. Way to go!

A nail in the anti-vax coffin? Maybe...

I have two links of importance today regarding the anti-vaccination hubbub.

The first is a Discover Magazine blog entry on the full retraction of the Lancet Vaccine research article - the article that got the anti-vax movement really started.

The second is news that Andrew Wakefield, the primary author of the study, has been found guilty of medical misconduct and will likely lose his license. There is a long list of evil this man has done in the name of his own agenda, and it is good to see justice served.

This is probably not the final nail in the coffin of the anti-vax debate. I wish it were, for the world would be much safer if everybody got their vaccines.

Journal of Homeopathy: wheat

According to ScienceDaily, the journal Homeopathy has published a 2-part special issue on the biological models of homeopathy. Being the obsessive quirk that I am, I decided to get ahold of this 2-part special issue of Homeopathy to see what all the fuss is about.

ScienceDaily says that:

The special issue makes an important contribution to this debate, by reviewing laboratory experiments with high dilutions. It includes reviews and new findings in biosystems, ranging from whole animal behavioral, intoxication and inflammation models through diseased and healthy plant models, to test tube experiments using isolated cells, cell cultures or enzymes.

The editor in chief concludes that -

"Throughout its 200 year history claims that homeopathy has 'real' (as opposed to placebo) effects have been hotly contested. Our special issue brings together a wide range of scientific work in biological systems, where there can be no placebo effect, showing that there are now several biological experiments which yield consistently positive results with homeopathic dilutions."

One of the first articles I looked at was an article on the effect of arsenic on wheat seedlings [1]. This article was a review of an experiment on wheat seedlings that had been replicated 17 times among 2 research groups. The experiment was like this: To test potentiated arsenic as a cure for arsenic poisoning, researchers first exposed wheat seedlings to a 1%, 1.2%, or 1.6% solution of arsenic. Then, they had three outcome groups: 1 treated with water, 1 treated with 45X potentized water, and one treated with a 45X potentation of 1% Arsenic. Then, they measured wheat shoot length as an outcome after 7 days.

So, here's what happened with the two research groups. The first lab group conducted the experiment, and said experiment resulted in a 24% increase in shoot growth as compared to the placebo. This was the expected outcome, as homeopathic arsenic is taken to be a remedy for arsenic poisoning. A different research team later replicated the experiment, only to find the opposite – they found that the arsenic group had a reduction in hoot length by -3%. Curious about this discrepancy, they performed the experiments again. They found no statistically significant effect. So, they performed a meta analysis of all of the seed data and found a 3.2% reduction in seed growth and an (apparently nonsignificant) trend in reduction of germination rates.

The authors report that these findings are puzzling, but the fact that there was any effect at all shows that homeopathy does something. Their conclusion is that treatment of arsenic poisoned wheat seeds with homeopathic arsenic leads to statistically significant, yet contrary, effects. Without going into huge amounts of detail, I can say that the authors did a fairly good job of eliminating other factors that might have contributed to their results. Regardless, the meta-analysis certainly did not show that homeopathic arsenic is an effective treatment for arsenic poisoning in wheat.

I think that the experiment producing both positive, negative, and no effects does not point to homeopathy having some kind of effect, but rather it illustrates that science is messy and inexact. A 3.2% difference in wheat shoot growth is barely noticeable. Their mean growth rate was between 29 and 65mm. When a meta analysis reveals a 3.2% difference between treatment groups, we're talking about a difference in wheat shoot measurements of 1-2mm.

Surprisingly, the researchers in this paper talked about effect size. Effect size, simply is a measure of the strength of the relationship between two variables. In scientific experiments, it is often useful to know not only whether an experiment has a statistically significant effect, but also the size of any observed effects. In other words, if we look at a group of 20 people in a treatment group and 20 people in a placebo group, there might be significant differences, even when those differences are essentially meaningless. What is really important is how much these groups are different or how big the differences are. It is always possible to show that there is significant difference between two groups, unless they are 100% Identical. The important part is to what degree groups are different. For this, you need to know the effect size. In this case, the effect size of a 3% difference between their wheat groups amounts to 0.04. Effect size for Cohen's d an effect size of 0.2 to 0.3 might be a "small" effect, around 0.5 a "medium" effect and 0.8 to infinity, a "large" effect. If a small effect is from 0.2-0.3, and the effect size of the experimenter's wheat growth is 0.04, then I would chalk up the differences to experimental noise. This difference in groups is immensely tiny.

I have to wonder why the experimenters chose only 7 days of germination instead of taking measurements at 14 days, and then at 28 days. I don't know if a 1-2mm difference in shoot length among groups will actually translate into any measureable effects of plant size as the plants grow, but since the authors of this paper did not comment on further growth after the 7 day period, one cannot make any claims either way. There are also about a million factors that can influence early seed growth. I admit only rudimentary knowledge of horticulture, but even if seeds are placed side by side in rows in a pan, there could be enough of a difference in lighting, soil temperature, air temperature, and carbon dioxide distribution to account for the small differences seen among groups, even if the groups are dispersed. One thing the experimenters did do was to look for statistically significant differences among shoot growth of 2 pans of seeds where the seeds were placed side-by side and subjected to otherwise identical growing situations. They didn't find any differences. Here is how they arranged the seeds:

The 90 envelopes of each cardboard box were grouped in 9 groups of ten seeds each. The 9 groups of each box were randomly allocated to 3 3 treatment groups with the aid of a computer generated randomization list. The list was prepared newly for each box and each experiment. Thus, in one box, ten seeds of the first group were followed by ten seeds of the second group, and so on (corresponding to the order in which they were planted).

There are other research papers on homeopathy for treatment of arsenic poisoning. One was a study conducted on mice [2] which produced positive results, but it was unblinded. There have been other studies conducted on humans, but I'll just say that the guys over at NESS tore those studies apart. I am unconvinced that this minute difference among plant seedlings will translate into a clinically meaningful effect with regard to using homeopathy as a treatment for disease (also noting that the tiny effect the researchers found in their meta-analysis was contrary to homeopathy, stunting shoot growth rather than increasing it) and the standards for validity of non-homeopathic remedies are much higher. Given all of the other research published on homeopathy which has shown that its effects are equivalent to placebo in humans, I have to wonder why researchers are backtracking into preliminary studies and then saying, "See? High dilutions do something… even if what it does is barely measurable and contrary to the law of similar" when we already have ample evidence that homeopathy is of little clinical use.

1. Lahnstein L, Binder M, Thurneysen T, Frei-Erb M, Betti L, Peruzzi M, Heusser P, Baumgartner S. Isopathic treatment effects of Arsenicum album 45x on wheat seedling growth – further reproduction trials. Homeopathy (2009) 98:198-207
   
2. Mallick P, Chakrabarti (Mallick) J, Bibhas G, Khuda-Bukhsh AR. Ameliorating Effect of Microdoses of a Potentized Homeopathic Drug, Arsencium Album, on Arsenic-Induced Toxicity in Mice. BMC Complementary and Alternative Medicine, (2003)3:7

Time to make some predictions…

In a few days, at exactly 10:23 on January 30th, over 300 skeptics (well, sceptics, because they are in the UK) are going to take part in a massive homeopathic "overdose".

The folks putting it together are over at 1023.org have this to say:

Sceptics and consumer rights activists will publicly swallow an entire bottle of homeopathic 'pillules' to demonstrate that these 'remedies', prepared according to a long-discredited 18th century ritual, are nothing but sugar pills.

The protest will raise public awareness about the reality of homeopathy, and put further pressure on Boots to live up to its responsibilites as the 'scientist on the high street' and stop selling treatments which do not work.

I am going to try to amass a St. Louis version of this even, but I have to work fast, because this is only in 11 days!


I have a few predictions to make:

1. This will not dissuade the true believers of homeopathy.
   
2. True believers will claim that this experiment is invalid, or they will screech that we "don't understand homeopathy" or they will insist that an overdose isn't possible, or make up all sorts of silly excuses as to why the mass overdose somehow demonstrates nothing.
   
3. 
   
   We'll be accused of being shills for "big pharma".
   
   
   
   
   

I've started collecting patent medicines – you know, liniments and female pills and camphor and laxatives from the 1800's – Most of this stuff we consider bunk today, as it was made back in the day when anyone and everyone could patent medicines without verifying that their claims were real. The history of patent medicine is completely fascinating to me.

For some really good info on patent medicines, you can visit the Smithsonian exhibit on the latter.




Homeopathy is patent medicine. It's a throwback to the days when medicines were sold unregulated, unchecked and untested. I suppose some snake oil was bound to survive the glorious days before drug regulation – especially when homeopathy practitioners managed to convince the FDA that homeopathy needs no regulation beyond labeling restrictions (homeopathy is only allowed to be labeled as a curative for nonspecific ailments or self-limiting conditions). At any rate, having hundreds of skeptics swallow bottles of homeopathic remedies should certainly get the attention of someone.

Homeopathy with the light of Saturn

Just when I thought homeopathy could not get any more ridiculous, a relative of mine (Technically, he is my first cousin, once removed: My dad's cousin) who is a fellow skeptic sent me this link to a "Trituration Proving of the Light of Saturn". In homeopathy, a "proving" is "A process in which a medicinal substance is given to a group of healthy people and the signs and symptoms thus produced are recorded". Homeopathy rests on that "law" (imagine me making the biggest quote marks with my fingers as humanly possible right here) that the "remedy" which will cure a patient is the one that has the same effect on people as does the disease. In other words, if a certain substance irritates your lungs, that same substance - when highly diluted - will cure you of irritated lungs.

During a proving, individuals are exposed to a substance in a lab or other controlled environment, and all of their "symptoms" (again, imagine me making giant quote marks with my finders) are recorded. Homeopaths record not only obvious "symptoms" (like a rash, or raised blood pressure) but non-obvious "symptoms" such as thinking of music, having an itch, or feeling euphoric. Anything is taken as a "symptom" of the substance. This is considered a "proving" and the substance then is said to be able to cure these symptoms once "successed" based on the "law of similars".

Essentially, a "proving" is the worst kind of confirmation bias and confusion of correlation with causation imaginable. Usually homeopaths do a "proving" on substances such as arnica, duck liver, dog urine, or other actual substances – but they often also do "proving" on substances such as energy fields or the light of Saturn. In this case, the homeopaths "expos[ed] powdered milk sugar to a powerful telescope in Boston, Massachusetts while it was focused on the planet Saturn during April 2009". Then, they triturated (ground using mortar and pestle) the powdered-milk-exposed-to-the-light-of-Saturn into a 3C mixture. What this means is that they took one part of the powdered-milk-exposed-to-the-light-of-Saturn and ground it up with 99 parts of "unexposed" powdered milk three times, for a final "potency" of 1:1,000,000.

While the homeopaths were grinding the powdered milk (they did this for 3 hours), they recorded their feelings. I am just going to republish the whole thing, because it is worth reading. Forget for a moment the plausibility of powdered milk exposed to the light of Saturn via a telescope and then diluted with more powdered milk to a ration of 1:1,000,000 having any effect on people beyond the effect one gets from plain old powdered milk and just focus on the supposed "symptoms":

3. The Proving themes and excerpts

Spaciness, High feeling, Drugs

The trituration process began with lots of giggling and silliness; and throughout there was talk of getting high, stories about getting high. Senses were distorted. One prover kept seeing smoke rise from the milk sugar as she ground and scraped. "Drugs come into the mainstream… truckers used speed to stay awake. Ecstasy was first used for marriage counseling." "I'm feeling really high… spacey." Provers were laughing until the tears came. "You guys are ripped." "I feel like I smoked." "Sound is distorted as if I'm high…" "Do you remember the first time you smoked?"

Music

One prover jotted down chords on a piece of paper. There was a long conversation in which provers named their 5 favorite Beatle songs of all time. One prover told a story of a man with severe short term memory loss; the only things he could recall were "music and love." Provers were humming and singing "stand by me, "dust in the wind, "when the night has come."

Food/Drink

The conversation kept circling back to pizza: "Any food in the universe can be better with cheese." "The best pizza in the world was in Italy – pumpkin and mascarpone." "I'm getting hungry." "oven roasted peanuts…." "Boston baked beans are popular in Boston. " "Lemonheads are still 25 cents; always have been." "I'm excited about a Kalamata olive pizza – no sauce but olive oil, cheese, tomatoes . I am so excited I bought pizza dough." One prover demonstrated a seductive way of eating a sandwich: "if I could get food that way I would never be hungry…" Provers were very thirsty, drank a great deal of water.

The Horned God: Sensuality, Eroticism

One prover made a drawing on his notepad - it started out as a drawing of one of the other provers but then he added horns and a beard. It looked like Pan, or a satyr. From the start, conversation was filled with erotic double‐entendres ("How's my technique?" ) . The chords one prover wrote were to a song another prover heard as "erotic computer" and another as "erotic amputee." One prover demonstrated a seductive way of eating a sandwich: "if I could get food that way I would never be hungry…" "I want to draw you naked…" Story about Angelina Jolie tongue kissing her brother at the Oscars.

Time

The timekeeper had tremendous difficulty keeping track of the time for the grinding and scraping of the remedy throughout the entire process. One prover made a list of dates going back 10 years and wanted a major historical event named for each year. There was a long discussion about 1969, Woodstock, Chappaquidick, the moon landing, and also about time speeding up and slowing down. " Funny how time gets so blurry no matter how much we try to define it." "no matter how old we are we perceive ourselves as young and in the moment. Discussion of "My stroke of Insight," the memoir of the stroke survivor who is also a neuroscientist. Provers recalled incidents when time had slowed way down, such as an accident was happening. " Life and death moments go in slow motion."

Physical Endurance, Survival, Accidents, Nerve and Bone damage

There was a long discussion about people going through life threatening events and exhibiting almost inhuman strength or endurance in order to survive. "A guy was picked up by a tornado, dropped from several hundred feet ‐‐- he didn't break a bone." "Free style runners know how to manipulate their bodies so that they don't get hurt." "A man in an avalanche lifted 1000 lb rock off of himself…" Provers told many stories of themselves and people they knew surviving bad car accidents, many broken bones, broken backs and necks. Long discussion of phantom pain, amputations, strokes, memory loss, multiple knee surgeries, about how people re‐learn movement.

Disasters, End of the World, Death

When identifying key events for the list of dates mentioned in the section about Time, the only events that were named were disasters and wars– Katrina, the Tsunami, the invasions of Iraq and Afghanistan ‐‐ and significant people's deaths. There was a discussion about how the world was supposed to have ended on 6/6/06, and now again in May, 2012. That date had been changed to December 21, 2012, a prover said. "That is my birthday, the winter solstice," commented a prover. "how do you want to die?" "in a bear fight…" Discussion of the movie "Grizzly Man, " and how he was ultimately killed by bears.

From High to Low

Toward the end of the trituration, near the 3 hour mark, provers' energy flagged and they described feeling "lost and confused…over time it begins to piss you off, not being able to fully participate in life, what is happening … I will just check out." "I feel exhausted and a little drained.. .. At first there as definitely a physical / mental high, then I felt really out of it and now tired." "I feel tired as well as airy, light‐headed… Interested as to what purpose this serves."

Physical Symptoms:

Itching. The female provers especially experienced a great deal of itchiness: Head, nose, eyes itchy. Head itchy. Back itchy, breasts itchy, thighs. Waves of itchiness in various parts of body, especially head. Desire to yawn and stretch Heat, Hands hot, sweating. Hot flushes, Overheated – sweating, Hands sweating, Head Pain, Head pain over eyes. Sharp pain right temple. Pressive pain right temple. Head ache over left eye. Eyes watery and running, burning, itchy. Runny nose, itchy nose, sneezing. Eyes tired and heavy. Eyes staring. Hands shaky, numb. Legs numb. Feet numb. Right hand stiff and sore. Left shoulder ache. Back ache between shoulder blades. Achey all over. Sound distorted. Spaciness Incoordination: Spilling milk sugar. Frequent urination.

Based on these "symptoms", the provers determined that:

"It is interesting that the trituration proving reflected some themes of Saturn that appear in myth and astrology. (The spontaneous drawing of the Horned Pan figure is of course amazing!)

From a homeopathic point of view, both the physical symptoms that appeared and the content of the discussion during the proving suggest that this remedy might be effective for accident‐related trauma, bone and nerve damage. The Titan‐like quality of strength, survival and endurance seems connected; perhaps an ability to survive disasters is part of this remedy. This remedy may also be effective for allergies, in light of all the itching that occurred.

Emotionally, we see the 'lighter' side of Saturn less a sense of weightiness and more of an emphasis on eroticism and fun. (The trituration itself had some saturnalian elements!) This could be because it is a planetary light. Towards the end of the trituration, we saw some of the more serious aspects of Saturn emerging, although throughout the proving and underneath all the silly banter were some heavier themes – most notably the accounting and recounting of history and disasters.

The power of suggestion displayed here is pretty astonishing. Just because a group of people talked about pizza and Angeline Jolie while grinding powdered milk for three hours does not mean that the grinding of powdered milk (exposed to the light of Saturn) caused this. The contention that this is a good remedy for accident-related trauma simply because people talked about accidents is astoundingly stupid – do I need to explain why? This is completely unethical. Homeopathy should not be used for accident-related trauma because people were thinking about accidents while making the remedy.

People get "itchy" all the time, and if a group of people are looking for anything that might be an "effect" of a "remedy", one scratch could easily be misconstrued as "itching". Once people honestly believe that an itch-causing substance is around them, they are a lot more likely to experience spontaneous itchiness. In fact, I bet some of you are… itchy… right… now. Reading my blog caused you to be itchy! We should expose some powdered milk to my blog and use it for a remedy for allergies!

In fact, I'd encourage all of my commenters to post their feelings as a comment right now. Then, I can expose some powdered milk to my blog, dilute it, and then sell it as an effective remedy for… whatever.

Alternative medicine and SCI

I just started a new internship here in St. Louis, and one of my duties is to familiarize myself with a book called Yes, You Can: A Guide to Self-Care for Persons with Spinal Cord Injuries. It is produced by the Paralyzed Veterans of America, a federal organization. In it, there is a chapter on alternative medicine, which states, among other things:

The FDA does not approve or regulate any natural supplement, for several reasons. Herbal and botanical preparations contain multiple ingredients. The quantity, quality, and strength of these ingredients are often unknown and can vary from plant to plant. These compounds are not patentable, so the herbal manufacturer could never make enough money to afford to seek research trials and approval from the FDA.

This sentence seems to indicate that alternative medicine might work, but since the supplements are not patentable, people do not seek research trials of the medicine – the problem is lack of research. This is untrue. A simple search of Pubmed will generate thousands of published research papers on alternative supplements. The government itself spent billions of dollar testing sCAMs (supplements, complementary and alternative medicine). If a sCAM were proven in research to be effective, the cost of FDA approval is not prohibitive. While one cannot patent a plant, one can trademark the name associated with good research, or plant blend proven to be effective, et cetra. Most "supplements" are produced by large pharmaceutical corporations anyway, so appropriate research proving their particular product works would be a huge boon to business. This is a poor argument, and I was surprised to find it in an otherwise science-based text. Here is something else I found:

There is limited evidence, based on scientific research, that some categories of alternative medicine are effective. Several studies have indicated that therapeutic touch, massage, and acupuncture have improved both acute and chronic medical conditions. Several natural supplements have shown promising improvements in particular diseases and their symptoms.

In properly conducted research, there is no evidence that therapeutic touch works. There is clear evidence that therapeutic touch practitioners cannot detect the presence or absence of "energy fields" – it's hard to manipulate something that does not appear to exist. Massage has therapeutic benefits, mostly for increasing circulation, relaxation, and increasing tissue mobility. Studies have shown repeatedly that one can get the same effects without puncturing the skin and without using particular acupuncture points – in other words, poking someone with a toothpick anywhere on their body has the same therapeutic effect as sticking needles in particular spots. Performing an invasive procedure on people (needle insertion) is not without risk. Putting someone at risk when one can accomplish the same results without putting them at risk is unethical. Acupuncture is therefore unethical. I can, however, recommend sham acupuncture to anyone – it's a great placebo with no risk at all.

Speaking of alternative medicine, the other day someone told me that the reason I don't believe in homeopathy is because I am an atheist – homeopathy requires belief in the soul, and so therefore I will use "atheist arguments" to discredit homeopathy. I just thought I would mention that being an atheist means you don't believe in god. The existence of a soul is a separate question. One can be an atheist without believing in souls. One can also believe in souls without believing in homeopathy, and one can probably believe in homeopathy without believing in souls. I don't believe in homeopathy because there is no evidence that it is effective and the mechanism is implausible in that it contradicts physics.

Really though, the chapter this book offered on alternative medicine was science-based aside from these two paragraphs. It described how chiropractic is not recommended for people with spinal cord injuries and gave tables of side effects or contraindications of using sCAMS. It was written in 2000, so perhaps it claims that there is evidence for sCAMS because it is outdated.

Urban Health Fair Pt. 5

This will be my last post on a series of blog posts documenting my visit to the Urban Health Fair in St. Louis. Previous posts can be found here, here, here and here.

After getting a chiropractic scan and an acupuncture treatment, I headed over to a booth run by Colonics and Detox 4 Health, run by a woman who is a "Certified Sr. Wellness Coach", a "Certified Colon Hydrotherapist (advanced level)" and a "Certified Clinical Aromatherapist". They were having people get scanned with a device called the ZYTO Compass.

The ZYTO compass is a device in which people place their hand on a hand cradle attached to a computer, and the cradle measures galvanic skin response. It looks like this:

The device is said to measure "energy patterns" in the skin. I am skeptical. According to the flyer I picked up, it measures "76 bio-markers" in order to "indicate your body's preferences to help bring it back into a state of balance, and consequently, improved health". Apparently it looks for "supplements to bring every one of these bio-markers back into range". Here is what the company website says about the device:

Have you ever found it difficult to decide which nutritional supplements you should be taking or helping your customers make the same decision for themselves? Often times you're making your best guess based on how your customers are feeling or what they think they need. Wouldn't it be nice if you could ask their body what it preferred? With the Compass System you can.

The Compass System combines the power of dynamic changes in the electrical properties of the skin with ZYTO's Decision Support Technology software. ZYTO technology measures the fluctuations in the energy patterns of the skin. The primary feedback mechanism is called GSR or Galvanic Skin Response. When your customer places his or her hand on the Compass hand cradle, the ZYTO software sends stimuli to the body using digital signatures representative of various alternatives like nutritional supplements. Each stimulus creates a unique GSR response which the ZYTO software measures and analyzes. It's like asking the body questions about your nutritional products and listening to its answers.

When your customers place their hand on the Compass hand cradle, the state of the art Compass software uses stimulus-response to 'ask their body questions' about your nutritional products and then ranks their responses. Armed with this new information your customers feel more positive about the supplement choices they are about to purchase. Supplement Distributors using the Compass have shown astounding increases in monthly product sales.

I sat down, gave the computer my information, and then waited while the device scanned me. While I waited, pretty graphics flitted across the screen, telling me about the 76 bio-markers and explaining that the device would help me increase my wellness by bringing my body back into balance through the use of essential oils. It took about ten minutes for the device to scan. When it was finished, the computer produced a list of essential oils recommended to me by the Compass.

A woman approached me and let me know she was a certified clinical aromatherapist. She tried to explain to me that because the Compass kept recommending essential oils made from trees (elm, cedar, etc) that I must have some sort of structural problem. To really emphasize her point, she made a fist with her right hand and held her arm vertically while pressing it into her left hand – as if her arm were a tree trunk. She told me that she kept "doing this" (meaning making her arm look like a trunk) to really bring home the fact that my body was seeking stability. I looked at her blankly and told her I had no structural problems (really I do, but who – at 27 – has no "structural problems"?) To double-check the findings of the Compass, she brought over the Essential Oils Desk Reference, which looked remarkably like a clinical textbook. She went through some other essential oils she thought my body could use based on the readings of the Compass, asking if I had urinary tract infections, digestive problems or problems with circulation, but eventually sent me on my merry way.

According to the F.A.Q. the Compass uses, "quantum physics as well as established Galvanic Skin Response (GSR) technology to measure fluctuations in electrical conductivity of the skin." How does one use quantum physics to measure fluctuations in electrical conductivity in the skin? One needs no understanding of quantum physics to measure electrical resistance, which is what GSR measures. I guess since I measure kinetics of wheelchair propulsion, I can say I use biomechanics and quantum physics in my research.

Galvanic Skin Response (GSR) is basically a measure of electrical resistance through the skin. It measures how conducive the skin is between two measurement points. The skin's conductivity is highly effected by moisture and temperature – so readings of people with sweaty hands (like me) are going to be different than readings of someone with dry hands by virtue of moisture, and readings will be different depending on the temperature of the skin – which will obviously be effected by many things, including atmospheric conditions – how warm, cool, humid, or dry it is, among other things. GSR is used in polygraph tests, the theory being that stress tends to cause perspiration and raise skin temperature. There is no mechanism by which galvanic skin response could measure "bio-markers" or determine if you have an imbalance that can be corrected by the administration of essential oils. I did a Pubmed search on GSR's effectiveness as a diagnostic tool and found a study attempting to determine if GSR readings were diagnostically useful in allergy clients. The study showed that GSR was not useful. [1] GSR can be useful in the diagnosis of anxiety disorders or in nerve conduction disorders (such as MS), however.

The website indicates that research has been done, but (surprise!) gives no references to journal articles or the research. Instead it says, "Health professionals using ZYTO technology have performed hundreds of thousands of assessments worldwide and report excellent results. A recent hospital study showed a high correlation between the information provided by ZYTO's technology and the recommendations made by attending physicians". The site also claims that a study was done in China and is "set to be published in a peer reviewed journal". One of the more entertaining claims is this:

ZYTO technology involves information theory, biology, physics, and biofeedback. Each of these disciplines have several studies that validate the individual components that makes up the ZYTO technology. For example, there are several studies over the last century relating to GSR and its use in measuring the body's reaction to stimuli.

Yes, people have validated physics, biology, and information theory (biofeedback is up for debate). But this does not mean that these things have been validated for use in determining which essential oils you need to balance your body. I emailed the company asking for a reference. We will see what happens. A casual reader might take this sentence to mean that ZYTO scanners are used in hospitals. This is not what this sentence says – instead, it says that the "technology" ZYTO uses (meaning quantum physics and GSR) are used in hospitals, and there is a correlation between quantum physics and/or GSR information and physician recommendations. What I assume is that this: "A recent hospital study showed a high correlation between the information provided by ZYTO's technology and the recommendations made by attending physicians." Means that some hospital somewhere used GSR for some diagnostic purpose, and so therefore ZYTO feels it can claim GSR can be used to test for "imbalances". This is akin to a company staying since X-ray's have a high correlation between the information provided by the X-ray and recommendations made by physicians setting broken bones, that X-ray is useful in detecting Qi. I did a Pubmed search looking for instances in which "quantum physics" was used as a diagnostic tool and found nothing, aside from discussions of the physics of radiography.

ZYTO insists that their device is not a "medical device" which is why it is not FDA approved. Here is the FDA definition of a medical device:

..an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is . . . .

• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  
• intended to affect the structure or any function of the body of man or other animals, and which [is not a drug].
  

ZYTO has this explanation for why their device does not count as a medical device:

We often compare our technology to the clipboard, pen, and printed health history form that a doctor gives a new patient. These are tools used to gather information about the patient. The completed health history has significant clinical value, but that does not mean the clipboard, pen, and printed form are medical devices.

Although information gathered with ZYTO technology can have significant clinical value, that information is simply another form of questionnaire (called a bio-survey) and ZYTO technology is simply the tool used for 'filling in the form.'

Yes, but an X-ray, CT scanner, PET scanner and an MRI are tools used to gather information about a patient, and those are considered medical devices. By this argument, we should deregulate these devices, as they are simply a tool used for "'filling in the form'". How is the Compass any different, aside from the fact that there is no evidence that it works?

It clearly is an instrument, and while it may not be diagnosing a disease, it could be said to be mitigating or treating disease. This is especially true if an individual is said "structural problems" according to the device and is then sold an essential oil to prevent osteoporosis. To say that no diagnosis is being made when one is giving a label to a medical condition or disease is kind of like a Southern Baptist minister insisting he is not religious. Using mealy-mouthed words like "preference" "decisions" and "imbalance" should not make a device immune to FDA approval, especially when statements like this (from the flyer) are made:

ZYTO Technology is used by more than 5,000 doctors and health care providers to make decisions on the health care needs of their clients with 95% proven accuracy.

I wondered if, taking the scan again, the results would be the same or different – if the results were consistent, at least the Compass might have something going for it. Alas, the F.A.Q. tells a different story:

ZYTO technology measures the most rapidly changing field in the body, the energetic field, which processes 400 million impulses of information per second. When dealing with complex mind-body systems, repeatable measurements are not always expected. However, in most instances successive bio-surveys will produce comparative results; each bio-survey will present a picture that is comparative in a meaningful way to the others. Health professionals and others with bio-survey experience learn that results obtained from the first bio-survey are valid and the most accurate.

In order to receive the most accurate results on subsequent scans you need to wait at least three days before scanning a person a second time. Your average client should be scanned about once every few weeks although many users prefer once per month.

Why would you have to wait? How can this device be both accurate yet have results that are not replicable? We expect repeatable measurements from real medical devices. The reason the Compass does not always yield repeatable results has to do with the fact that GSR does not measure "biomarkers", it measures skin conductivity. There is no reason a "first" reading will be more or less accurate than subsequent readings. There is no reason one would have to wait three days.

My analysis of this product is that it is a marketing tool. It is designed to sell people things by pretending to measure things it does not measure. I call bullshit. So does Stephen Barrett, by the way.

Additionally, the company (meaning the book I visited who used the Compass) also offers these sCAM (supplements, complementary and alternative medicine) services: Wellness coaching, Detox foot baths, Rife machine, colonics, aromatherapy, reflexology, custom blend essential oils and educational literature. They sell essential oils, vitamins, minerals, superfoods, Chinese herbs, homeopathics, natural soaps, household cleansers, shampoos, and dental care.

1. Semizzi M, Senna G, Crivellaro M, Rapacioli G, Passalacqua G, Canonica WG, Bellavite O A double-blind, placebo-controlled study on the diagnostic accuracy of an electrodermal test in allergic subjects. Clinical & Experimental Allergy 2002;32:928-932
   

Urban Health Fair Pt.4

For those of you just joining us, I attended an Urban Health Fait (AKA buffet of woo) a few weeks ago and lived to tell the tale. Previous posts can be found here, here and here.

After Michael, Michael's son "Indigo" and I got our free Chiropractic surface EMG sca(m)ns, Indigo was running out of patience and so the two of them left me to fend for myself. I decided to fend for myself by getting acupuncture.

For some reason, the acupuncture booth was actually giving people free acupuncture sessions – real needles, real invasive techniques, real nonexistent gloves on practitioners, real open air, real possibility of cross-contamination due to performing an invasive procedure on people while they sat in reclining chairs covered by blankets. Not to mention I had my dog with me, and they didn't care that he lay at my feet.

I approached the acupuncture booth and observed people reclined in chairs with little silver needles poking out of their knees, wrists, neck or ears. As I stood there, a kindly acupuncturist asked me if I wanted to try. Yes, I did want to try! I signed some paperwork that I did not read, waited a few minutes for a chair to open up and hopped on in. Note that even though someone else had been sitting here before me with needles in their skin, no cleansing of the reclining surfaces was done. To be fair, the risk of cross-contamination is pretty minimal as people do not typically bleed during acupuncture, but the fact that people were performing an invasive procedure on people on a closed off city street without much thought for sanitation concerned me slightly – obviously it didn't concern me enough.

The acupuncturist asked if I had tried acupuncture before, and I hadn't. I told him that I was a skeptic, but that I would give it my best shot. I happened to have a headache at the moment, so after describing the location of my headache, the acupuncturist said, "Oh, I have points for headaches". I asked him if I could take pictures for my blog. He said sure. My dog sat down between myself and another lady getting acupuncture. The acupuncturist returned with a set of tiny silver needles and explained that they were all single use only and had been sterilized. He may have cleaned his (bare) hands before sticking needles into me, but I don't quite remember if this is the case. He cleaned my skin with a little alcohol swab though. I have several ear piercings and you had better believe those guys use gloves – sterile ones – and they typically they go through several pairs for one ear piercing, if they're good. The picture below is of the acupuncture needles in my leg:

As the guy sat down on a stool and prepared to poke me, I asked him if he had read the Newsweek article which focused on the fact that acupuncture is no more effective than placebo acupuncture. He hadn't read it. I asked him which journal articles he had read on acupuncture. He said he had read a few, but could not recall the specifics. He told me that he did not believe real double blind placebo controlled studies could be performed with acupuncture, for two reasons: 1. Acupuncture is a procedure, and so that would be like doing a double blind placebo controlled study on surgery. 2. Practitioners really can't be blinded to whether they are doing real or sham acupuncture – they know if the points are wrong or the needles are wrong. He also said that most of the good studies are in China where the acupuncture needles are gigantic and hardcore – people apparently think that nothing is working unless they are in a lot of pain. Um, really? That's news to me, and I've read a lot more peer reviewed journal articles on acupuncture than he has. Here are the needles in my arm. Note the blue blanket on the chair.

When I relayed Flimsy's story of his mother suffering a collapsed lung after an acupuncture treatment, he balked – he does not put needles on people's torso at all, and think it's dumb that people have to read and sign to an agreement stating that lung collapse is a risk of acupuncture.

Clearly, the acupuncturist does not understand that double blinding means that the people who do the outcome measures and the participants are the ones who are blinded – not necessarily the acupuncturist. Someone is going to end up being unblinded, even in pill placebo studies – but as long as that person is not measuring outcomes that is okay. The point is that the patient does not know if they are in the treatment group or placebo group, and the person(s) measuring the effect of the treatment and placebo groups do not know which group a participant is in. Also, comparing acupuncture to surgery is not an appropriate metaphor – one could also say that ingesting a pill, given a vaccine, or rubbing Neosporin on a cut is a procedure too, if acupuncture is a procedure. Also, this means that placebo or sham acupuncture must be a procedure as well!

On top of this, people have done double blind placebo controlled trials on surgery. [1] Frighteningly enough, the double-blind placebo controlled trial of the specific surgery (knee surgery for osteoarthritis) showed that the surgery was no more effective at reducing pain of increasing function than placebo.

The acupuncturist, stuck two needles in each of my knees, two needles in each of my wrists, and a needle on either side of my neck. I was instructed to relax – and I did. For five minutes, I relaxed in the chair, listening to the brass band music waft over to me and feeling the gentle breeze rustle the blanket on the reclining chair. I gave it my best shot, honest to science. I wanted those needles to get rid of my headache, and I tried to believe that they would.

My headache was unchanged, so all of you folks out there who love anecdotes should add that to your arsenal. Acupuncture did nothing for me. It didn't even hurt getting the needles put in, wiggled around, pushed in further, or pulled out. Then again, I've got a high tolerance for pain and I actually like needles – I've engaged in quite a few play piercing sessions with needles much more hardcore than the flimsy acupuncture ones.

1. Moseley JB, O'Malley K, Peterson NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. New England Journal of Medicine 2002;347:81-88

Urban Health Fair, Pt.3

This is part 3 of my blog series on a visit I made to the Urban Health Fair in St. Louis. Here are parts one and two.

After Michael, Micheal's son (I'll call Mike's son Indigo from now on) and I got a book about Indigo Children, the three of us wandered over to a booth featuring a chiropractic organization. They were offering "free scans" using a surface EMG scanner.

The three of us decided that we should all get scanned. While we were waiting, Michael turned to me and said, "Aww look honey, our son is going to get his first chiropractic scan!" which gave us the perfect excuse to whip out our cameras and photograph the momentous occasion.

An EMC surface scanner is a tool used in chiropractic practices as a diagnostic tool. According to this chiropractic website:

"The Surface EMG scanner is a tool that helps [a licensed chiropractor] gain additional inforamtion (sic) about your condition. Your muscles are controlled by nerves. The Surface EMG measures how well the motor nerves are working by readying (sic) the amount of current found in the muscles. Subluxations disturb the function of the nerve causing an abnormal amount of electrical current flowing to your muscles (indicated by colours and /or abnormal patterns). This advanced tool also looks at muscle balance and thermal differences."

After reviewing 2,500+ resources, the American Academy of Neurology concluded that these devices are not an acceptable tool for measuring or diagnosis any neuromuscular disease or for diagnosing low back pain. [1] Basically, surface EMC superficially measures electrical activity an area of muscle territory. Moving a muscle at all, whether voluntarily or involuntarily, will be recorded as electrical activity. Surface EMG cannot differentiate which muscle is the origin of a signal. It does not measure "abnormal current flowing to your muscles caused by subluxations". Chiropractors have yet to show that subluxations are even real or that they cause ailments.


I work in a biomechanics lab where we frequently use EMG to record muscle activity. This involves placing electrodes on the skin at a muscle's origin and at the muscle belly, then we have people move around (typically they walk back and forth across the room). This is admittedly a highly imprecise science, and we have a large fudge factor in our results, knowing that EMG readings vary greatly due to electrode placement and even from day to day with the same placement. If a person is sitting quietly, we get tiny readings – or none, if the muscle is completely still. When they move around, we get much larger readings.

The scanning device was used on the back of our necks – essentially, it measured the muscle activity in our necks as we sat in a chair. Since people use their neck muscles to hold their head aloft, there will always be electrical activity in the neck, assuming the person is sitting up. There will also be lots of electrical activity if you're a young fidgety child.

After the three of us were scanned, we sat and waited for our results. We were first shown an image like the one pictured, that showed "normal nerve function", and then shown "our nerve function". The results made it clear that we were supposed to believe the surface EMC measured the specific nerve function of the cervical nerves from C1-C7. Surface EMG is entirely incapable of producing results this precise – and does not measure nerve conduction. As you can image, our little bars and graphs (which were only on the neck, as this is where we were scanned) showed that we were "maladjusted". In particular, Indigo's readings were much higher than ours. Painstakingly, the chiropractor walked us through our problem, talking inordinately slowly, to make sure we understood the gravity of our results:

"See this picture here? Notice how all of the lines and bars are equal, level, short and green. This is what you should look like if you are properly adjusted." We nodded. "Now, look at your results here. You will notice some differences. What do you see that is different?"

I sighed. "Some of the lines are red and very long, here at C3 on the right and here at C5 on the left. Also, there are some longer yellow lines here."

"Yes! That means that your nerves are not balanced, which could be due to a subluxation. In particular, the red lines are very bad. C1-C3 is often associated with problems in the ears, eyes, throat, and nose. It can cause things like recurring colds and allergies. Do you have a problem with colds or allergies?"

No.

Next, the chiropractor turned to Indigo's results, which showed high levels of activity particularly at C7. The Chiropractor told us that this could lead to problems with Indigo's eyes. As Michael put it, "I guess I forgot from my anatomy classes that the optic nerve goes from the eyes to the spine and then down to C7 then turns around and goes up to the brain." For the record, the ocular, auditory and gustatory systems are innervated by cranial nerves. That is, they are all located in your skull. They do not loop down to the cervical spinal cord and then back up to your eyes, nose and ears. There is no way that a "subluxation" can affect these systems – this is a basic fact of anatomy.

The chiropractor told us that children usually have higher readings because they are very active and young and thus have a high level of muscle and nerve activity. I told him that this made sense, because someone had told us he was an "indigo child". The chiropractor nodded knowingly and said something like, "Yes, I know all about indigo children, I have plenty of experience with them"

As Michael and Indigo ran off to play in the children's area, the chiropractor stopped me and let me know that people who visited them today at the health fair would be eligible for a discounted first visit to the office – something like $40 instead of the typical $120. She asked if I wanted to sign up to take advantage of the special deal. I told her I'd have to think about it, and then I walked off. Too bad they didn't scan my dog too.

I really have a problem with chiropractors treating little children. Their vertebra have not fully developed into bone yet and consist of a much larger portion of cartilage than that of the adult spine. The fact that chiropractors used to believe that polio was best treated by manipulation should be enough to send mothers and fathers running (away, that is). This would not be anything to balk at, except for the fact that many chiropractors are still against vaccines and germ theory.

1. Pullman SL, Goodin, DS, Marquinez AI, Tabbal S, Rubin R. Report of the Therpeutics and Technology Assessment Subsomittee of the American Academy of Neurology. Neurology 2000;55:171-177. Online here.
   

Acupuncture affecting regulation of pain

A new acupuncture vs. placebo acupuncture study has been making headlines such as "Chinese acupuncture affects brain's ability to regulate pain, study shows" due to results of a study suggesting that there may be a difference in opioid receptor response in acupuncture vs. placebo acupuncture.

Several large-scale studies [1-3] have been released showing that acupuncture and various forms of placebo acupuncture have clinically insignificant differences in the reduction of pain, proponents of acupuncture are now looking at brain-imaging to explore the mechanisms of acupuncture and placebo acupuncture to determine if acupuncture and placebo acupuncture operate via different mechanisms.

In this study [4], researchers hypothesized that long term acupuncture therapy may result in increased opioid receptor availability and that these effects would not be observed in a placebo acupuncture group. Their subjects consisted of 20 women randomly divided into 2 groups of 10 subjects. One group received traditional acupuncture treatment while another group received non-invasive, placebo acupuncture. Results from PET scans using contrast material were taken during a 90-minute period, during which acupuncture treatment or sham acupuncture treatment was administered during the 45-90 minute timeframe. A period followed in which subjects received 7 acupuncture or sham acupuncture treatments, and then the PET scan procedure was repeated, for a total of 9 treatments. Results indicate acupuncture therapy evoked short-term increases in MOR binding potential, in multiple pain and sensory processing regions including the cingulate (dorsal and subgenual), insula, caudate, thalamus, and amygdala. Acupuncture therapy also evoked long-term increases in MOR binding potential in some of the same structures including the cingulate (dorsal and perigenual), caudate, and amygdala. These short- and long-term effects were absent in the sham group where small reductions were observed, an effect more consistent with previous placebo PET studies.

There are several pieces of information regarding this study that were left out of news headlines an abstracts, so I will attempt to summarize them here and then offer my own analysis of the results. However, it should be clear that I am not a neurologist, and thus my knowledge of neurology is somewhat limited.

Subjects were blinded to which treatment group they were in, and they were also asked to guess which treatment group they thought they were assigned to after the first PET scan. There was no significant difference between groups, and thus it can be assumed that the subjects remained adequately blinded, though the study does not mention any blinding of the researchers, making it quite likely that the researchers were unblinded, which could have an effect on the study results.

During the acupuncture treatment, needles were left in during PET scan acupuncture treatment measurement during the 45-90 minute timeframe, while no needles were retained during the sham acupuncture group given that no needle penetration occurred during sham acupuncture. Clearly then, PET scans during that 45-90 minute period involve one group receiving an active treatment (given that needles were in their skin) while the sham group received inactive treatment (given that no needles were present). It seems obvious to me that there will be neurobiological differences between a group of people being measured while needles are inserted into them and a group of people who do not have needles in them, so their results are not surprising. Additionally, even though subjects may have not know which group they were in (they had to have had no prior acupuncture experience to participate), they quite likely were aware of whether or not needles remained in place during the PET scans, especially given the fact that both treatment groups involved placement on the head and ear. This knowledge could provide an explanation for the differences in treatment groups and is not addressed in the study. As such, even though the subjects were ignorant of whether or not they were receiving placebo treatment or not, the same cannot be said of their ignorance of the presence of needles placed in their body during PET scans.

What I find especially interesting about this study is the discussion of opponents of acupuncture in the introduction. The researchers wrote:

“Recent controversy in the field of acupuncture research was generated when several large scale randomized controlled trials in chronic pain patients failed to show superiority of acupuncture over sham acupuncture methods. This has led opponents of acupuncture therapy to suggest that it is no more effective than a placebo intervention.”

I fail to see why one needs to be an opponent of acupuncture therapy to suggest exactly what the large scale randomized controlled trials are suggesting – that acupuncture therapy is not superior to placebo intervention. This sentence seems to indicate potential bias on the part of the researchers in this study. The data from these studies are very clear.

If the clinical results between acupuncture and placebo acupuncture are the same, it seems to me that potential side-effects are far more important than the fact that acupuncture and placebo acupuncture potentially operate via different mechanisms. This difference in mechanisms is irrelevant, or at least far less relevant than clinical results or side effects. It could be argued that different types of placebo acupuncture have different neurochemical mechanisms of action as well, but thus far no study has documented these potential differences. This study is weak in that it only compares two different treatments. If the study had used acupuncture and two different types of placebo acupuncture that had already been established through trials to have similar clinical results, and then shown that the mechanism of action for the placebo acupuncture was the same while the acupuncture group had a different mechanism, then the results would be more convincing.

The researchers indicated that previous studies indicated that the neurobiological response to acupuncture was distinct from pain and sham acupuncture, but one of the articles [5] I read in support of this claim (there were three total, and all appeared to be from the same group of people as evidenced by common authors. I read the newest one.) failed to blind subjects to which treatment they were receiving and thus is poor evidence to support their claim. Instead, this seems to support evidence that there is a different neurobiological response in individuals who know they are receiving acupuncture or a placebo, which is to be expected.

Regardless, it seems fairly obvious to me that measuring neurobiological responses in a PET scan while some subjects have needles inserted during the scan and others do not is measuring a neurobiological response to needles being in the skin versus not in the skin.  Sticking needles in subjects would likely provoke a different neurochemical response in subjects when compared to placebo acupuncture, which involved no needle insertion. So, if you do two different physical things to people, this provokes different neurochemical responses. Didn’t we already know this? At least this study does not argue that acupuncture and placebo acupuncture have different effects. Instead, it argues that acupuncture and placebo acupuncture have different mechanisms. My less than dignified response is, “So what?”


1. Brinkhaus B., Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Walther HU, Melchart D, Willich SN. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch. Intern. Med. 2006;166:450–457.


2. Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA 2005;293:2118–2125.

3. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C,Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D, Weidenhammer W, Willich SN, Linde K. Acupuncture in patients with tension-type headache: randomized controlled trial. BMJ 2005;331:376–382.

4. Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs) NeuroImage 2009;47:1077-1085

5. Napadow V, Kettner N, Liu J, Li M, Kwong KK, Vangel M, Makris N, Audette J, Hui KK.  Hypothalamus and amygdala response to acupuncture stimuli in carpal tunnel syndrome. Pain 2007;130: 254–266.

How much money do we spend on CAM?

Finally! A real survey outlining the cost of Supplements, Complimentary and Alternative Medicing (SCAM's) has been published by a government survey.

Now, when people use "Big Pharma" as a scapegoat for illogical arguments about why SCAM's work, we can point out that "Big SCAM's" have their fingers in the healthcare pie too. Read on:

Americans spent $33.9 billion out-of-pocket on complementary and alternative medicine (CAM) over the previous 12 months, according to a 2007 government survey [1]. CAM is a group of diverse medical and health care systems, practices, and products such as herbal supplements, meditation, chiropractic, and acupuncture that are not generally considered to be part of conventional medicine. CAM accounts for approximately 1.5 percent of total health care expenditures ($2.2 trillion [2]) and 11.2 percent of total out-of-pocket expenditures (conventional out-of-pocket: $286.6 billion [2] and CAM out-of-pocket: $33.9 billion[1]) on health care in the United States.

Approximately 38 percent of adults use some form of CAM for health and wellness or to treat a variety of diseases and conditions, according to data from the 2007 National Health Interview Survey (NHIS) [3]. 

Of the $33.9 billion spent on CAM out-of-pocket, an estimated $22.0 billion was spent on self-care costs—CAM products, classes, and materials—with the majority going to the purchase of nonvitamin, nonmineral, natural products ($14.8 billion) such as fish oil, glucosamine and Echinacea. U.S. adults also spent approximately $11.9 billion on an estimated 354.2 million visits to CAM practitioners such as acupuncturists, chiropractors, massage therapists, etc.

To put these figures in context, the $14.8 billion spent on nonvitamin, nonmineral, natural products is equivalent to approximately one-third of total out-of-pocket spending on prescription drugs, and the $11.9 billion spent on CAM practitioner visits is equivalent to approximately one-quarter of total out-of-pocket spending on physician visits.

"These data indicate that the U.S. public makes millions of visits to CAM providers each year and spends billions of dollars for these services, as well as for self-care forms of CAM," said Richard L. Nahin, Ph.D., MPH, acting director of NCCAM's Division of Extramural Research and lead author of the cost of complementary and alternative medicine analysis. "While these expenditures represent just a small fraction of total health care spending in the United States, they constitute a substantial part of out-of-pocket health care costs."

 Here are some important references. I suggest you memorize them:


1. Nahin, RL, Barnes PM, Stussman BJ, and Bloom B. Costs of Complementary and Alternative Medicine (CAM) and Frequency of Visits to CAM Practitioners: United States, 2007. National health statistics reports; no 18. Hyattsville, MD: National Center for Health Statistics. 2009.

2. Office of the Actuary, Centers for Medicare and Medicaid Services, National Health Expenditure Data for 2007. U.S. Department of Health and Human Services. Available at: http://www.cms.hhs.gov/NationalHealthExpendData/02_NationalHealthAccountsHistorical.asp#TopOfPage.

3.  Barnes PM, Bloom B, Nahin RL. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. National health statistics reports; no 12. Hyattsville, MD: National Center for Health Statistics. 2008.

Chinese Herbal Medicine for Endometriosis

Media outlets are reporting that Chinese herbs may relieve symptoms of endometriosis, using a Cochrane review of 2 research articles. Headlines read “Chinese herbs show early promise for endometriosis”  and  “Chinese Herbs May Relieve Endometriosis Symptoms, Review Finds”  .

Endometriosis is a medical condition in which some of the endometrial cells (typically found in the uterus under the fluctuating influence of female hormones) are found outside of the uterine cavity. Symptoms include many nonspecific complaints such as pelvic pain, infertility, nausea, unusual menstruation, chronic fatigue, mood swings, back pain, ovarian cysts, constipation, urinary tract infections, diarrhea, anemia, etc. Appropriate diagnosis is by laparoscopic biopsy – a doctor will use a laparoscopic instrument to remove suspected extrauterine endometrial cells and examine them.  Treatments vary and can include hormonal treatments or surgery to remove the cells. In China, treatment of this disorder with Chinese herbal medicine (CHM) is routine.

Both of the media reports linked to above say that the Cochrane reviewers found some evidence that CHM has comparable benefits to conventional drug therapy after laparoscopic surgery for people with endometriosis but that the review has limitations. The primary author of the study is quoted as saying “"I think the positive message is that Chinese herbal medicine may offer equivalent benefits to conventional medicine but with fewer side effects.”

I found the Cochrane review [1] and noted that reviewers collected 110 studies for review and graded them based on methodological criteria. They dropped all but two of the 110 studies due to excluding trials with poor methodology, unconfirmed randomization procedures or ones diagnosing endometriosis without an appropriate laparoscopic biopsy.

Did the two retained articles feature research with superior methodology? First, let’s look at what those two articles were, and what the author concluded from this review:

The first article [2] had two treatment arms: women treated with CHM orally (2x/day) and via enema (1x/day) after laparoscopic surgery versus women treated with gestrinone (2x/wk) after laparoscopic surgery for 3 months. The results showed no difference between rates of symptom relief or pregnancy in either group.

The second article [3] had three treatment arms: women treated with CHM orally(2x/day), women who treated with CHM orally and via enema(1x/day), and women treated with danazol(1x/day) for 3 months. These women did not undergo laparoscopic surgery, but instead were only biopsied for diagnostic purposes.  Women obtained greater symptomatic relief with oral and oral plus enema CHM versus danazol, oral plus enema CHM shower a greater reduction in dysmenorrhoea pain scores than danazol and shrinkage of adenexal masses. There were no differences for other factors (lumbrosacral pain, rectal discomfort, vaginal nodules).

The author concluded that post-surgical administration of CHM may have comparable benefits to gestrinone but with fewer side effects, that oral CHM may be better for treatment than danazol and may be more effective at relieving dysmenorrheal and shrinking adnexal masses when used with a CHM enema.

So, what are our weaknesses?

1.    No placebo control: There was no arm of the first study which looked at women receiving laparoscopic surgery alone without CHM or danazol, and no arm of the second study which looked at women receiving no treatment or a placebo pill treatment.

2.    Poor blinding: I should not have to point out that if you enroll in a study that has a pill treatment arm and an enema treatment arm, it is impossible for the participants to be blinded to which treatment group they are in. And enema, as you probably know, is a procedure in which liquids are forced into the rectum through the anus. It might be possible to blind participants to whether or not they are getting CHM versus the other medications, but I bet most people can tell the difference between a Chinese medicine pill and the other pills in the study. The researchers were also not blinded as to which treatment group women were in, though the paper indicates the assessors were blinded to which treatment group the women were in.

3.    Inadequate comparison treatments: Danazol is no longer commonly used as a treatment for endometriosis, and gestrinone is not available in the USA. These studies would have been much more robust had they compared it to typical drug treatments for endometriosis. In the world of conventional treatments for endometriosis, these two drugs can hardly be called conventional.

4.    Poor outcome measures: In both of the studies, a clinical outcome of “no effect” was recorded if there were no change in symptoms or if the symptoms became worse. Recording worsening symptoms as “no effect” biases the data toward a positive outcome.


I think that the most appropriate take home message or finding of the study is this: the massive stockpile of clinical trials that explore CHM for treating endometriosis have serious methodological shortcomings. 

The author’s main conclusion (and the conclusion parroted by the press), that CHM may work to alleviate symptoms of endometriosis, seems spurious in light of this. Additionally, it appears that researchers used a specific mixture of herbs (Nei Yi) in the two studies, which raises the question: why the author did not title his paper “Nei Yi for endometriosis”?  Perhaps he wanted his readers to focus on the fact that this was a Chinese herbal medicine versus a “conventional” medicine.

Lastly, it is worth noting that although the authors of the review state that there is no conflict of interest in the publication of this review, the primary author is an acupuncture and Chinese medicine practitioner at a center for Chinese medicine in the UK.

References:

[1] Flower A, Liu JP, Chen S, Lewith G, Little P. Chinese herbal medicine for endometriosis. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD006568. DOI: 10.1002/14651858.CD006568.pub2.

[2] Wu SZ,Chen XL,Chen WZ, Li SY.Clinical analysis of the treatment of endometriosis using Nei Yi pills and Nei Yi enema. Journal of Liaoning University of TCM 2006;8(7):5–6.

[3] Wu SZ, Chen XL, Chen WZ. Clinical observation of Nei Yi pills combined with Nei Yi enema in the treatment of endometriosis. Chinese Archives of TCM 2006;24(3):431–3.

homepathy yet again: funny video

This video is all over the skeptisphere, but I don't care - I am going to post it again!

Also, I realize this video will be so big that it covers up some of the sidebar. I can't find a good way around this, you'll live.