Great article about Acapuncture

NeuroLogica Blog » Why I Am Skeptical of Acupuncture

Acupuncture is the practice of placing very thin needles through the skin in specific locations of the body for the purpose of healing and relief of symptoms. This practice is several thousand years old and is part of Traditional Chinese Medicine. As practiced today it is often combined with other interventions, such as sending a small current of electricity through the needles or burning herbs on the acupuncture points (a practice called moxibustion).

Acupuncture has recently been transplanted to the West, riding the wave of tolerance for unscientific treatment practices marketed as “complementary and alternative medicine.” While advocates have been successful at pushing acupuncture into the culture, the scientific medical community has still not accepted the practice as a legitimate scientific practice. I count myself among those extremely skeptical of acupuncture. I outline here the reasons for my continued skepticism.

1) Acupuncture is a pre-scientific superstition

Proponents often cite acupuncture’s ancient heritage as a virtue, but I see it as a vice. Acupuncture was developed in a pre-scientific culture, before anything significant was understand about biology, the normal functioning of the human body, or disease pathology. The healing practices of the time were part of what is called philosophy-based medicine, to be distinguished from modern science-based medicine. Philosophy-based systems began with a set of ideas about health and illness and based their treatments on those ideas. The underlying assumptions and the practices derived from them were never subjected to controlled observation or anything that can reasonably be called a scientific process.

An example from Western culture of philosophy-based medicine was the humoral theory - the notion that health was the result of the four bodily humors being in proper balance while illness reflected one or more humors being out of balance. Treatments therefore sought to increase or decrease one or more of the humors (such as the practice of blood-letting) to re-establish balance. The humoral theory survived for several thousand years in Western societies, perpetuated by culture and the power of deception inherent in anecdotal evidence.

Acupuncture is based upon the Eastern philosophy of chi (also spelled qi), which is their name for the supposed life force or vital energy that animates living things. In Traditional Chinese Medicine (TCM) chi flows through pathways in the body known as meridians. Illness results from the flow of chi through the meridians being blocked, or by the two types of chi (yin and yang) being out of balance. Acupuncture is the practice of placing thin needles at acupuncture points, which are said to coincide with points at which meridians cross, to improve the flow and restore the balance of chi.

There is no more reason to believe in the reality of chi than there is in the four humors, or in the effectiveness of acupuncture than the effectiveness of blood letting.

2) Acupuncture lacks a plausible mechanism

Centuries of advancement in our understanding of biology has made the notion of life energy unnecessary. Further, no one has been able to detect life energy or formulate a scientifically coherent theory as to what life energy is, where it comes from, and how it interacts with matter or other forms of energy. Withn science, the vitalists lost the debate over a century ago.Without chi, there is no underlying basis for acupuncture as a medical intervention.

Recent attention given to acupuncture has attempted to bring it into the scientific fold by hypothesizing physical mechanisms for its alleged effects. For example, some proponents argue that the needles may stimulate the release of pain-killing natural chemicals, or relax tense muscles, or inhibit the conduction of pain through counter-irritation.

These potential mechanisms, while more plausible than the non-existent chi, remain speculative. Further, they would only explain a very non-specific effect of acupuncture (no better than rubbing your elbow after accidentally banging it against something hard). They might account for a temporary mild reduction in pain. Such mechanisms could not account for any of the medical claims made for acupuncture, or the alleged existence of acupuncture points.

Further, it is misleading to say that such mechanisms could explain “acupuncture.” Acupuncture is the needling of acupuncture points to affect the flow and balance of chi. Using needles to mechanically produce a temporary local counter-irritation effect is not acupuncture - even though it may be an incidental consequence of this practice and may have contributed to its perceived effectiveness.

3) Claims for efficacy are often based upon a bait-and-switch deception.

The most common example of the “bait-and-switch” for acupuncture are studies that examined the effects on pain of electrical stimulation through acupuncture needles. This is not acupuncture - it is transcutaneous electrical stimulation (TENS), which is an accepted treatment for chronic pain, masquerading as acupuncture.

This is not a quibble. Science requires unambiguous definition of terms and concepts. If acupuncture is said to be something scientifically then it must have some specific and unique characteristics. In medicine that means it should have a specific mechanism of action - and it is that mechanism that we would call acupuncture. Electrical stimulation is no more acupuncture than if I injected morphine through a hollow acupuncture needle and then claimed that any resulting pain relief was due to “acupuncture.”

Further, during a typical acupuncture treatment there are many other incidental effects that may occur. The atmosphere is often relaxing, and practitioners typically will palpate the “acupuncture points” prior to inserting the needles, for example. Practitioners also provide their kind attention, which has a positive psychological therapeutic value. There are therefore many nonspecific subjective effects that could lead to clients feeling better, making the actual insertion of needles an unnecessary component.

Reports of acupuncture anaesthesia are also misleading. Independent investigation shows that patients having surgery under anaesthesia (dramatic reports of which are largely credited with acupuncture’s popularity in the West) reveal that patients were receiving morphine in the IV fluid. Other reports indicate that patient were experiencing great pain, but were simply instructed to remain quiet by the surgeon (a product of Eastern culture). There are no verified reports of acupuncture serving as effective anesthesia during surgery.

4) Clinical trials show that acupuncture does not work

The previous points are all reasons to be highly skeptical of the claims made for acupuncture, but they are all also trumped by the ultimate consideration - the direct scientific evidence. There is a surprisingly large published literature on the clinical effects of acupuncture. Most people are equally surprised to learn that the literature is essentially negative - probably because the press cherry picks apparently positive studies and re-prints without investigation the press releases of acupuncture proponents.

It is important to evaluate the literature as a whole to see what pattern emerges. The pattern that does emerge is most consistent with a null effect - that acupuncture does not work.

Controlled clinical trials of actual acupuncture (uncontrolled trials should only be considered preliminary and are never definitive) typically have three arms: a control group with no intervention or standard treatment, a sham-acupuncture group (needles are placed but in the “wrong” locations or not deep enough), and a real acupuncture group. Most of such trials, for any intervention including pain, nausea, addiction, and others, show no difference between the sham-acupuncture group and the acupuncture group. They typically do show improved outcome in both acupuncture groups over the no-intervention group, but this is typical of all clinical trials and is clearly due to placebo-type effects. Such comparisons should be considered unblinded because patients know if they were getting acupuncture (sham or real).

The lack of any advantage of real over sham acupuncture means that it does not matter where the needles are placed. This is completely consistent with the hypothesis that any perceived benefits from acupuncture are non-specific effects from the process of getting the treatment, and not due to any alleged specific effects of acupuncture. In other words, there is no evidence that acupuncture is manipulating chi or anything else, that the meridians have any basis in reality, or that the specific process of acupuncture makes any difference.

More recent trials have attempted to improve the blinded control of such trials by using acupuncture needles that are contained in an opaque sheath. The acupuncturist depresses a plunger, and neither they nor the patient knows if the needle is actually inserted. The pressure from the sheath itself would conceal any sensation from the needle going in. So far, such studies show no difference between those who received needle insertion and those who did not - supporting the conclusion that acupuncture has no detectable specific health effect.

Taken as a whole, the pattern of the acupuncture literature follows one with which scientists are very familiar: the more tightly controlled the study the smaller the effect, and the best controlled trials are negative. This pattern is highly predictive of a null-effect - that there is no actual effect from acupuncture.

Criticism of an Acapuncture trial

Respectful Insolence: The largest "randomized" acupuncture study ever done: Why did they even bother?

Believe it or not, there was one area of so-called "alternative" medicine that I used to be a lot less skeptical about than I am now. Homeopathy, I always realized to be a load of pseudoscientific magical thinking. Ditto reiki, therapeutic touch, and other forms of "energy healing." It didn't take an extensive review of the literature to figure that out, although I did ultimately end up doing fairly extensive literature reviews anyway. Then, the more I looked into the hodge-podge of "healing" modalities whose basis is not science but rather prescientific and often mystical thought, the less impressed I was.

Even so, there was always one modality that I gave a bit of a pass to. There was one modality that, or so I thought, might actually have something to it. There was one modality that seemed to have a bit of suggestive evidence that it might do something more than a placebo. I'm referring to acupuncture. No, I never bought all the mystical mumbo-jumbo about how sticking needles into "meridians" somehow alters or "unblocks" the flow of a mysterious "life force" known as qi that is undetectable by science. I did wonder if perhaps it worked as a counterirritant or by releasing endorphins.

Then I actually started paying attention to the scientific literature regarding acupuncture, including literature like this and this. The more I read, the more I realized something. I realized that there was far less to acupuncture than I had previously thought, and, even with my previous openness to it, I hadn't thought all that much about it anyway. What I had thought about it was that it might have a very mild beneficial effect. What I know now is that acupuncture is almost certainly no more than an elaborate placebo. What I know now is that virtually every study of acupuncture claiming to show a positive effect has serious methodological flaws and that the better-designed the study the less likely there is to be an effect. What I now know is that any study without a true "sham" acupuncture arm is worthless, and that well-designed studies show "sham" acupuncture to be no different than "real" acupuncture; i.e., no different than placebo.

And now comes yet another in a long line of studies that is consistent with just that, and, worse, it's billed as (and probably is) the "largest randomized study of acupuncture ever done." Too bad it depends on what you mean by "randomized." Too bad the press coverage misses the point:

For the current study, published in the journal Cephalalgia, German researchers followed more than 15,000 adults with chronic headaches; all had been suffering from either migraine or tension-type headaches at least twice a month for 1 year or more.

Of these patients, nearly 3,200 agreed to be randomly assigned to either have acupuncture added to their regular therapy or to stay with their usual care alone. The rest of the patients began on acupuncture treatment.

All of the acupuncture patients received up to 15 sessions over 3 months, and all study patients were reassessed after 6 months.

In the end, the study found, acupuncture patients reported greater pain improvements than those who stayed with their usual care only. At the outset, they reported an average of 8.4 headache days over 3 months; that dropped to 4.7 by the study's end.

Take a minute here. If you're a regular reader of this blog, I'm betting that you can pick out the huge methodological flaw in this study from just the press report alone. Do you have it yet? Don't worry, I'll get to it very soon. However, I don't like to rely on just the news coverage of such a study. Whenever possible, I always like to go to the original study, and, as I usually do, I did just that. Here's the abstract:

We aimed to investigate the effectiveness of acupuncture in addition to routine care in patients with primary headache (> 12 months, two or more headaches/month) compared with treatment with routine care alone and whether the effects of acupuncture differ in randomized and non-randomized patients. In a randomized controlled trial plus non-randomized cohort, patients with headache were allocated to receive up to 15 acupuncture sessions over 3 months or to a control group receiving no acupuncture during the first 3 months. Patients who did not consent to randomization received acupuncture treatment immediately. All subjects were allowed usual medical care in addition to study treatment. Number of days with headache, intensity of pain and health-related quality of life (SF-36) were assessed at baseline, and after 3 and 6 months using standardized questionnaires. Of 15 056 headache patients (mean age 44.1 ± 12.8 years, 77% female), 1613 were randomized to acupuncture and 1569 to control, and 11 874 included in the non-randomized acupuncture group. At 3 months, the number of days with headache decreased from 8.4 ± 7.2 (estimated mean ±s.e.) to 4.7 ± 5.6 in the acupuncture group and from 8.1 ± 6.8 to 7.5 ± 6.3 in the control group (P < 0.001). Similarly, intensity of pain and quality of life improvements were more pronounced in the acupuncture vs. control group (P < 0.001). Treatment success was maintained through 6 months. The outcome changes in non-randomized patients were similar to those in randomized patients. Acupuncture plus routine care in patients with headache was associated with marked clinical improvements compared with routine care alone.

Got it yet?

I'm sure that most of you do; so I'll just move on. This study has three design flaws so glaring that I almost don't even care what it shows because the flaws are so significant that they scuttled the study before it even started. Here they are:

1. The study is not only not double-blind, it's not even blinded in any way. Both the patients and the health care practitioners know who is receiving what therapy. That alone makes its result entirely explainable by placebo effects.
2. There isn't even an attempt at a sham acupuncture group. Remember my previous posts on the importance of sham acupuncture and how sham acupuncture is indistinguishable from "real" acupuncture.
3. The "randomization" isn't even really a randomization. Of 15,056 patients with a complaint of headache, only 3,404 accepted randomization to control or acupuncture. Normally a clinical investigator, when faced with this situation, studies only the patients who agreed to be randomized. Not these intrepid woo-mavens! They included the remaining 11,652 patients anyway. Actually, they included 11,874 nonrandomized patients.

There are a number of other flaws, but, really, they pale in significance to the three above and are hardly worth mentioning except in passing. For example, there were significant differences between the randomized and nonrandomized groups, including higher pain intensity and a shorter duration of chronic headaches, making them prime candidates to be prone to regression to the mean. The study is also suspect because it lumps together all headaches, rather than separating out the migraine headaches, which have a different physiological mechanism behind them than run-of-the-mill headaches. Another problem was that the authors relied on questionnaires, rather than a pain diary. Because a questionnaire relies on patient memory, rather than the patient writing down an incident as it happens, it's prone to recall bias. There are also numerous other nits to pick, but none of them even come close to the three flaws listed above.

Regarding the failure to use a sham acupuncture group or to blind, it makes me wonder if all the studies coming out showing that sham acupuncture and "real" acupuncture are indistinguishable are starting to get to acupuncture advocates to the point where they really aren't even trying anymore. After all, an unblinded study is almost guaranteed to produce an effect, but an investigator has no way of knowing whether that effect is greater than placebo if there is no valid placebo group. True, the authors did all sorts of fancy statistics and handwaving to try to take the reader's mind off of this fundamental fatal flaw, but none of that changes anything.

Reading the discussion is very instructive, as it demonstrates very well the torturing of language and logic that is used by advocates of "alternative" medicine. While they admit flat out that this was an unblinded study and that , the excuse used was that this was a "pragmatic" study designed "chosen to reflect general medical practice." Yes, that's a great excuse not to do the necessary placebo/sham acupuncture control that would make the results of this study interpretable. It's also a lovely excuse to allow patients in essence to self-select for acupuncture by refusing randomization, thus making the likelihood of a placebo effect even greater--except that there's no control that allow us to know if it's just a placebo effect or not. Here's part of what they argue:

Although differences with respect to both baseline characteristics and treatment outcomes between randomized and non-randomized patients were small in absolute numbers, our findings indicate that randomization was associated with some selection effects. Therefore, the use of study designs that also include non-randomized patients appears to be desirable.

It is of note, however, that treatment benefits were similar in the randomized and nonrandomized acupuncture groups after adjusting for baseline differences. This suggests that the results of randomized trials can be representative of routine medical care situations, at least in large pragmatic studies.

No, it suggests that the placebo effect was operative in both the randomized patients and the patients who refused to be randomized. The use of study designs that include non-randomized patients is only "desirable" if you want to maximize the chances of a seemingly positive result. Bravo, though, to the study authors for having the chutzpah to try to change this study's most glaring weakness into a strength. It was a nice try, but it won't fly.

What's truly depressing is the editorial by Dr. H-C Diener of the University Hospital Essen in Germany, where he actually makes this argument:

Despite the fact that I have major design issues with the study, my view is that studies like this have to be published in high ranked journals to promote discussion on trial design in non-drug trials

Dr. Diener actually lists two of the same flaws that I did, namely the unblinded nature of the study and the lack of adequate "sham" acupuncture controls. In spite of this, he still argues that this article should be published in high ranked journals "to promote discussion"? Funny, but I always thought that high ranked journals are high ranked because they post the most scientifically sound and medically interesting articles. Think New England Journal of Medicine. I always thought the reason for such journals to publish an article is because it is scientifically sound and studies a clinically important and/or interesting question. As a reason to publish such an article, "to promote discussion" is about as far down on the list of reasons as "because the author has nice hair."

The bottom line is that this study is yet another of a long line of studies of "complementary and alternative" medicine that are entirely consistent with the placebo effect. Worse, it didn't even really try to distinguish between a treatment effect and placebo effect. Maybe that's the point. Whatever the point was, what I do know is that if I were a German citizen, I'd be mightily pissed off that so much money was wasted on this study. I'd also wonder why it was a consortium of insurance companies who funded the study. Maybe I was wrong about insurance companies funding woo. Maybe it is cheaper in the long run for them to pay for CAM than actual scientific medicine that's more than just a highly elaborate placebo.

REFERENCES:

1. Jena, S., Witt, C., Brinkhaus, B., Wegscheider, K., Willich, S. (2008). Acupuncture in patients with headache. Cephalalgia, 28(9), 969-979. DOI: 10.1111/j.1468-2982.2008.01640.x

2. (2008). Acupuncture for the treatment of headaches: more than sticking needles into humans?. Cephalalgia, 28(9), 911-913. DOI: 10.1111/j.1468-2982.2008.01650.x

The HK Ark

Biblical structure: Noah’s Ark

There’s a hulking, brown colossus looming over Tung Wan Beach on Ma Wan (Park Island). It’s biblical in proportion. Seriously.

In 2004, Andrew Yuen Man-Fai and Pastor Boaz Li Chi-Kwong of evangelical Christian media organisation Media Evangelism climbed Mt Ararat in eastern Turkey and found what they claimed were the remnants of Noah’s Ark. Excited and inspired by their discovery – which they documented on blurry video that was unfortunately corrupted by a “mysterious force” – they returned to Hong Kong determined to build a replica of the famous life-raft.

Four years later, they’ve done just that, with the help of Sun Hung Kai.

Built to scale on government-owned land at Ma Wan Park according to the dimensions mentioned in the Bible, the ark is one-and-a-half football fields long, 22.5 metres wide, and four storeys tall. It will house a museum to educate and enlighten the public, a 3D movie theatre, 200 hotel rooms, and several restaurants. In and around the edifice, there’ll also be both live and model animals, including, curiously, some two-headed turtles that, according to Yuen, exhibit the genius of God’s intelligent design.

Yuen also wants the Ark to spread a message of love and unity – after all, he reasons, we’re all in the same boat. “We have witnessed many crises on earth – not only global warming but also animals going extinct, as well as natural disasters like the tsunami,” he explains. “We want to remind people to love the earth and love life.”

The Ark is expected to open to the public by Easter 2009. There are also plans for a smaller, floating replica (estimated cost: up to $40 million) that will ferry passengers direct from Central to Ma Wan. So far the landed Ark has cost $10 million, which has been funded by a flood of donations from well-wishing Christians. Media Evangelism hopes to raise another $18 million.

Wikipedia Expeditions to the Ark

Brain Gym

Here's a lovely little idea from California discussed on BBC TV:



Follow this link on YouTube for the second part of Newsnight where Paxman interviews the company founder.

Read Bad-Science about it. A really wonderful discovery from Mr Goldacre.

Pheremone Cologne to attract girls

Since 1703, scientists have known about an organ in the nasal cavity known as the vomeronasal organ or VNO. They assumed it was an evolutionary relic - an organ that humans no longer used. However, in the last 25 years, scientists have discovered that the VNO is the receptor for pheromones. The VNO gives us a sort of "sixth sense", we can't see, smell, hear, or feel pheromones. As a matter of fact, we cannot consciously perceive pheromones at all, though experiments prove that they can work.

Now it has been proven conclusively, humans produce and react to pheromones, so much so that studies have even shown that exposure to men's pheromones can affect a woman's ovulation cycle, meaning, her readiness and interest in having intercourse. For example, it has been discovered that when the underarm sweat of women in different menstrual phases is placed under the noses of female subjects, the length of these subjects' own cycles is significantly altered. Underarm sweat has been shown to have a pheromone component - dehydroepiandrosterone. This explains why females living in close quarters, such as college dormitories, often have synchronized cycles.

Men and women exposed to pheromones claimed that they felt self-confident, attractive, and romantic. In tests of pheromone effectiveness, it has been found that 74% of subjects testing a pheromone product experienced an "increase in hugging, kissing, and sexual intercourse." Also interesting, foods that have been known for centuries to have aphrodisiac qualities, such as truffles and oysters, have recently been found to chemically correspond to human pheromones. Still not convinced?
A recent study conducted at The University of Chicago reports that the "Novel human pheromone formulation (Di-Dehydroepiandrosterone) increases sexual attractiveness."
The study shows, "The plasma pheromone levels increased in the Di-Dehydroepiandrosterone group by 22.6%" Eighty-four men participated in this study testing the chemical.
Forty-three used Pherlure (Di-Dehydroepiandrosterone), and forty-one used a placebo fragrance.
The men were asked to document all sexual activities for the duration of the 12-week experiment.
Results indicated that Pherlure users "sexual intercourse activity levels increased by 62.4%" while the forty-one placebo controls increased by only 2.8%, respectively.
Based on these results, the researchers concluded that, "Pherlure caused a statistically significant and distinct increase in those romantic behaviors in which a woman plays a major role. Thus, Di-Dehydroepiandrosterone does affect the sexual attractiveness of men to women."

ABC News conducted an experiment of their own to see if pheromones really do work. They took a set of identical twins and applied a pheromone oil to one twin and plain, old witch hazel to the other one. They took the twins to a bar and had them switch places throughout the night so no one would realize they were 2 different people. The results were amazing! 30 men approached the twin wearing the pheromones while only 11 men approached the sister wearing witch hazel. The use of pheromones appears to have tripled the success rate!

http://www.pherlure.com/

James Randi exposes.......