July 23rd, 2009 by Mark Crislip, M.D. in Better Health Network, Quackery Exposed
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While there are many taxonomies of SCAM, one thing almost all alternative therapies have in common is they are originally the de novo discovery of one lone individual. Working outside of the mainstream, they are the gadflies who see farther because those around them are midgets.
Hanneman conceives of homeopathy, the treatment of all disease.
Palmer conceives the cause of all disease and its treatment in chiropractic
Mikao Usui, while having a mid-life crisis, conceives Reiki.
Virgin births all. These pioneers boldly go where no man has gone before.
Others have been less acclaimed after seeking out new life. An example is Virginia Livingston, MD, the discoverer of the cause of all cancer (1). She discovered a bacterium, the cause of cancer, she called Progenitor cryptocides, which, unfortunately only she could grow. Her therapies include an autogenous ‘vaccine” made from your own urine, which will probably preclude widespread use even in alternative therapies circles. I wonder if Jenny would object to vaccines if there were naturally derived from the patients urine?
Discovering a new form of pathogenic microbiology that no one else can see or grow is not uncommon, since people seem to be unable to recognise artifact on slides, be it Oscillococcinum being seen by Joseph Roy 200 years ago or Virginia Livingston in the 1960’s. Sometimes I regret the discovery of H. pylori as a cause of gastritis as it gives the alternative microbiologists a medical Galileo to point at. H. pylori is used as an example, erroneously, of a bacteria causing disease that was laughed at by the medical establishment (Parenthetically, as my flawed memory has it, while I was an Infectious Disease Fellow the data for H. pylori came trickling in. I remember discussing the papers with one of my attendings who was an expert in GI infections. We all thought is was an interesting hypothesis and waited further data with interest. I cannot remember anyone dismissing the idea out of hand with derisive laughter. But then, I remain convinced that infections are the cause of all disease, at least the diseases that matter).
A letter from a reader led me to another lone reseacher who has discovered the cause and treatment of many, if not all, diseases. So may I introduce to you, Trevor Marshall, the developer of the Marshall Protocol. (As I have said many time, I want something in medicine named after me, and it is not the glove breaking during an exam. “Damn, I just had a Crislip. I need to go and clean my nails.” If Swan or Groshong can get some silly little catheter named after them, well, I should be good for some eponym). You have not heard of Trevor Marshall? Often the fate of originality is to languish in obscurity.
The Marshall Protocol has all the characteristics of modern alternative therapy: a single discoverer, a hitherto undiscovered biology, an unproven therapeutic intervention and one of the most aggravating issues in SCAM’s: Taking a scientific truth the size of a molehill and transmogrifying it into a Cascade Range of exaggerated disease etiology and treatment. Unlike most SCAM’s, however, as best as I can tell Dr Marshall does not seem to be in the business of making a business from his discovery, although he does have patent applications for his protocol.
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*This blog post was originally published at Science-Based Medicine*
July 14th, 2009 by Harriet Hall, M.D. in Better Health Network, Quackery Exposed
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A study published in Alternative Therapies in Health and Medicine is being cited as evidence for the efficacy of healing touch (HT). It enrolled 237 subjects who were scheduled for coronary bypass, randomized them to receive HT, a visitor, or no treatment; and found that HT was associated with a greater decrease in anxiety and shorter hospital stays.
This study is a good example of what I have called “Tooth Fairy Science.” You can study how much money the Tooth Fairy leaves in different situations (first vs. last tooth, age of child, tooth in baggie vs. tooth wrapped in Kleenex, etc.), and your results can be replicable and statistically significant, and you can think you have learned something about the Tooth Fairy; but your results don’t mean what you think they do because you didn’t stop to find out whether the Tooth Fairy was real or whether some more mundane explanation (parents) might account for the phenomenon.
Theoretical underpinnings
According to the study’s introduction:
Healing touch is a biofield- or energy-based therapy that arose out of nursing in the early 1980s…HT aids relaxation and supports the body’s natural healing process, i.e., one’s ability to self-balance and self-heal.” This noninvasive technique involves (1) intention (such as the practitioner centering with the deep, gentle, conscious breath) and (2) placement of hands in specific patterns or sequences either on the body or above it. At its core, the theoretical basis of the work is that a human being is a multi-dimensional energy system (including consciousness) that can be affected by another to promote well-being.
They cite a number of references to theorists who support these ideas. They cite Ochsman; he wrote a book Energy Medicine: The Scientific Basis which I reviewed, showing that despite the book’s title, there is no credible scientific basis and the “evidence” he presents cannot be taken seriously.
They cite Candace Pert, who said in the foreword to Ochsman’s book that Dr. Oschman “pulled” some energy away from her “stagnant” liver. She said the body is “a liquid crystal under tension capable of vibrating at a number of frequencies, some in the range of visible light,” with “different emotional states, each with a predominant peptide ligand-induced ‘tone’ as an energetic pattern which propagates throughout the bodymind.” Does this even mean anything?
They even cite the PEAR study, suggesting that it is still ongoing (it isn’t) and claiming it shows that “actions in one system can potentially influence actions of another on a quantum energetic level.” (It didn’t.)
This is nothing but imaginative speculation based on a misunderstanding of quantum physics and of what physicists mean by “energy.” It is a truism that electromagnetic phenomena are widespread in the human body, but there is a giant gap between that and the idea that a nurse with intention and hand movements can influence electrical, magnetic, or any other physical processes in the body to promote healing. There is no evidence for the alleged “human biofield.”
Previous Research
They cite several randomized controlled studies of HT over the last few years. One showed “better health-related quality of life” in cancer patients. One, the Post-White study, showed no difference between HT and massage. One small study by Ziembroski et al. that I couldn’t find in PubMed apparently showed no significant difference between HT and standard care for hospice patients. One study showed that HT raised secretory IgA concentrations, lowered stress perceptions and relieved pain, and results were greater with more experienced practitioners; but it only compared HT to no treatment and didn’t use any placebo treatment.
A pilot study compared 4 noetic therapies-stress relaxation, imagery, touch therapy, and prayer, and found no difference.
A larger study showed that neither touch therapy nor masked prayer significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention.
They cite a review of healing touch studies by Wardell and Weymouth It concluded “Over 30 studies have been conducted with healing touch as the independent variable. Although no generalizable results were found, a foundation exists for further research to test its benefits.” Wardell noted that “the question has been raised whether the field of energy research readily lends itself to traditional scientific analysis due to coexisting paradoxical findings.” This is a common excuse of true believers who find that science is not cooperative in validating their beliefs.
Study Design
237 patients undergoing first-time elective coronary artery bypass surgery were randomly assigned to one of 3 groups: an HT group, a visitor group, and a standard care group. All received the same standard care from the hospital. The HT group received preoperative HT education and 3 HT interventions. Practitioners established a relationship with their patients, assessed their energy fields, and performed a variety of HT techniques based on their assessment, including techniques that involved light touch and those that involved no touch (practitioners’ hands held above body). Sessions lasted 20 to 90 minutes; each patient had the same practitioner throughout the study. The “visitor” group patients were visited by a nurse on the same schedule. The visits consisted of general conversation or the visitor remaining quietly in the room with the patient. They mentioned that some visits were shortened at the patient’s request.
Results of the Study
The six outcome measures were postoperative length of stay, incidence of postoperative atrial fibrillation, use of anti-emetic medication, amount of narcotic pain medication, functional status, and anxiety. HT had no effect on atrial fibrillation, anti-emetics, narcotics, or functional status. The only significant differences were for anxiety scores and length of stay. The length of stay for the HT group was 6.9 days, for the visitor group 7.7 days, and for the routine care group 7.2 days, suggesting that the simple presence of a visitor made things worse(!?). Curiously, for the subgroup of inpatients, the length of stay was HT 7.4 days, visitor 7.7 days and routine care 6.8 days, which was non-significant at p=0.26 and suggested that both HT and visitor made things worse.
The mean decreases in anxiety scores were HT 6.3, visitor 5.8, and control 1.8. They said this was significant at the p=0.01 level. But the tables for results broken down by inpatient and outpatient show no significant differences (p=0.32 for outpatients and p=0.10 for inpatients). If it was not significantly different for either subgroup, how could it be significant for the combined group?
These discrepancies are confusing. They suggest that the significant differences found were due to chance rather than to any real effect of HT..
Problems with this Study
Four out of the six outcomes were negative: there was no change in the use of pain medication, anti-emetic medication, incidence of atrial fibrillation, or functional status. The only two outcomes that were significant were hospital stay and anxiety, and these results are problematic and might have other explanations.
It is impossible to interpret what the difference in length of stay means, because they did not record the reasons for delaying discharge. As far as we can tell from the paper, the doctors deciding when to discharge a patient were not blinded as to which study group the patient was in. It’s interesting that the visitor group length of stay was intermediate in the outpatient subgroup, but higher than control for the combined inpatient/outpatient group. They offer no explanation for this. I was puzzled by the bar graph showing these numbers, because the numbers on the graph don’t seem to match the numbers in the text. The numbers were manipulated: they did a logarithm transformation for length of stay “to handle the skewness of the raw data.” I don’t understand that and can’t comment. The range of hospital days is such that the confidence intervals largely overlap. In all, these data are not very robust or convincing and they raise questions.
They interpret the anxiety reduction scores (HT 6.3, visitor 5.8, and control 1.8) as showing a significant efficacy of HT, but it seems more compatible with a placebo response and a slightly better response for the more elaborate placebo.
There were fewer patients (63) in the visitor group than in the HT and control groups (87 each). This was not explained. The comparison of groups appears to show that the control group had significantly higher pre-op anxiety scores than either of the other groups, which would tend to skew the results
They didn’t use a credible control group. A visitor sitting in the room can’t be compared to a charismatic touchy-feely hand-waving practitioner. Other studies have used mock HT where the hand movements were not accompanied by healing thoughts. These researchers rejected that approach because they didn’t think it would be ethical to offer a sham procedure where the practitioner only “pretended” to help. Hmm… One could argue that they have provided no evidence that HT practitioners are ever doing anything more than pretending to help.
They don’t comment on how practitioners were able to “assess the energy fields” of their patients. Emily Rosa’s landmark study showed that practitioners who claimed to be able to sense those fields couldn’t.
The authors consist of 3 RNs (2 of them listed as healing touch therapists and presumably the ones who provided treatment in the study), a statistician with an MS, and two “directors of research” for whom no degrees are listed. The authors are clearly prejudiced in favor of HT.
They interpret this study as supporting the efficacy of HT. I don’t think it does that. I think the results are entirely compatible with a placebo response. With any made-up intervention presented with strong suggestion, one could expect to find one or two statistically significant differences when multiple endpoints are evaluated. And the magnitude of the improvement here is far from robust. This is the kind of result that tends to diminish in magnitude or vanish when better controls are used. I think the study is Tooth Fairy science, purporting to study the effects of a non-existent phenomenon, but actually only demonstrating a placebo response.
I wonder if better results might be obtained by having a patient advocate stay with the patient and offer reassurance, explanations, massage and other comfort measures – something like the doulas who have been shown to improve childbirth outcomes.
The frightening thing is that during the course of this study, patients increasingly bought into the HT belief system and refused to sign up for the study because they wanted HT and didn’t want to risk being assigned to a control group. And hospital staff bought into the belief system, were treated themselves, and became proponents of offering it to patients for other indications.
The paper ends with a rather incoherent statement one would not expect to find in a scientific medical journal: “At the very heart of this study is the movement toward recognizing that the metaphoric and physical heart are both very real, if we allow them to be.”
*This blog post was originally published at Science-Based Medicine*
March 23rd, 2009 by Steve Novella, M.D. in Better Health Network, Quackery Exposed
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The primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.
The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions. Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.
There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.
These conflicting motives create a disconnect in the minds and behaviors of many people. They pay lip service to science-based medicine, but are good at making juicy rationalizations to justify what they want to be true rather than what the science supports. We all do this to some degree – but, in my opinion, complementary and alternative medicine (CAM) is a cultural institution that is built upon these rationalizations. It is formalized illogic and anti-science conceals as science under a mountain of rationalizations.
Some recent news items and reports dealing with acupuncture demonstrate this disconnect quite well.
The BMJ
The British Medical Journal (BMJ) recently published a review of acupuncture studies in the treatment of chronic pain. Like most other reviews of acupuncture studies, the authors were not impressed. They concluded:
A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.
After decades of study and hundred of clinical trials, this remains the state of acupuncture research. The best studies continue to show an unclear effect, which cannot be separated from bias – which of course is the point of clinical trials. In other words, the signal cannot be separated from the noise. The most parsimonious interpretation of this fact is that there is no significant signal – acupuncture does not work.
But supporters of acupuncture prefer to go through a litany of rationalizations rather than acknowledge that simple fact (more on this later).
It was also recently announced that the BMJ group will be adding a new journal: BMJ Acupuncture. That’s right, an entire journal dedicated to studying (read “promoting”) acupuncture. The press release notes:
Acupuncture in Medicine is a quarterly title, which aims to build the evidence base for acupuncture.
I thought the purpose of research was to discover if a treatment works, not to build a case for it.
BMJ is a strange journal – it is generally of high quality but seems to have a blind spot for certain CAM modalities, like acupuncture. While it will publish critical reviews, like the one above, it also has published some low quality positive reviews – such as this one of acupuncture and IVF (in vitro fertilization). The review glosses over the disparity in study quality and location. Other reviews published around the same time showed no effect from acupuncture in IVF.
And the best individual studies to date show no effect. In fact, the most recent study showed that the placebo acupuncture group had slightly higher pregnancy rates by some measures than the acupuncture group (while other measures showed no difference). Again – the most parsimonious interpretation of this study is the null hypothesis – acupuncture does not work in IVF. But proponents twisted themselves into logical pretzels and offered up the astounding rationalization that placebo acupuncture must have some real effect.
To be clear, I am not against journals that specialize in one area, or practitioners that specialize in one form of treatment. Specialization is essential to deal with the modern complexity of medicine. However, we must recognize the significant risk of specialization – and that is the fallacy that is often summarized as follows: if your only tool is a hammer then every problem will look like a nail. It is unlikely that a journal or practitioner dedicated to acupuncture will ever reach the conclusion that acupuncture is a dead end and science-based medicine should move on. As an extension of this, specialty journals and specialist should follow well-established modalities. Forming a specialty journal dedicated to an unproven and dubious modality is problematic, to say the least.
More Rationalizations
A recent Washington Post article observes in its headline: “Millions embrace acupuncture, despite thin evidence.” It seems this reporter, Ellen Edwards, has grasped the essential disconnect, although she does not sufficiently explore an answer to the implied question – why? Why do so many accept acupuncture despite an enduring absence of scientific evidence? Ironically, the press has much to do with it. They are often complicit in misrepresenting the facts, and abetting the rationalizations that are necessary for those who should know better to continue to promote acupuncture despite the lack of evidence.
Some professional organizations are also complicit. The article notes, for example:
The American Medical Association takes no position specifically on acupuncture; the AMA groups it with other alternative treatments, saying “there is little evidence to confirm the safety or efficacy of most alternative therapies.” It says “well-designed, stringently controlled research” is needed to evaluate its efficacy.
Now, the AMA is not the best place to go for position papers on specific scientific questions in medicine. But if they are going to bother having any position, it should be better informed. They say that research is needed, giving the impression that there isn’t already a large body of research to inform out opinion about whether acupuncture works or not.
The notion that more research is needed is one of the most common rationalizations. That allows someone to put off forever concluding that their pet modality does not work – simply make the case for more research, which is easy to make sound like it’s a good idea. And of course anyone against more research must be closed-minded. For example, the story relates (standard disclaimer – I am aware that experts are often quoted out of context by journalists, so keep that in mind, but for the purposes of this post I will take the quotes at face value):
In 2007, NCCAM spent about $9.1 million on acupuncture research. While more is planned, Brent Bauer, an internist at the Mayo Clinic and director of its complementary and alternative medicine program, said the research is in its “toddlerhood.”
Nice touch – “toddlerhood.” That’s just a cute way of saying that more research is needed and you can comfortably ignore any current negative research. If the assessment were fair, then it could be justified. But we have already had several fairly sophisticated placebo-acupuncture controlled trials. This represents reasonably mature clinical research. I suspect
Bauer just does not like the fact that these best studies (like the IVF study above) are generally negative. I wonder – if these studies were positive would he still think they were imature and could be ignored?
Linda Lee, a gastroenterologist who is director of Johns Hopkins’s new Integrative Medicine and Digestive Center, is quoted as saying:
“We have this double standard. We are completely comfortable using pharmacological therapies that have not been subjected to clinical trials for the purposes we use them, but we are super suspicious of alternative therapies that haven’t been tested with randomized placebo trials. From a research point of view, I understand the criticism. But we physicians are in the healing business, and we have to go beyond the pharmacological solutions to understand the whole person,” she said. “Acupuncturists start with the whole person.”
Ah – the “holistic” gambit. This is just another rationalization to distract people from the uncomfortable fact, that she acknowledged. From a “research point of view” means “I understand that the best quality scientific evidence is negative.” And “we..are in the healing business” means “but I want to believe in this anyway.”
The double standard is also an incredible claim, because the opposite is true. SBM advocates want a single standard. What Dr. Lee is actually referring to is prior plausibility – scientific practitioners are more accepting of treatments that are biologically plausible, and are appropriately skeptical of treatments that are extremely implausible. It is also a tu quoque fallacy – we advocate high standards of science for all treatments, even plausible ones. If some doctors uses drugs unscientifically, that does not justify chucking science whenever it conflicts with our beliefs and desires.
It is, in fact, the CAM proponents who want a double standard. Imagine if after hundreds of studies the best a drug could do for any indication is a weak effect that is likely just placebo – the signal cannot be separated from the noise. Imagine a pharmaceutical company making the exact same rationalizations to put its failed drug on the market anyway that acupuncture proponents make for acupuncture.
The article concludes, as most do, with a positive anecdote from a believer – Elise Feingold:
“I decided to leave my science brain aside,” she said. “I felt it had helped other people, and it might help me. I don’t know how it works, but it’s got 4,000 years of Chinese medicine behind it.”
She begins with what amounts to saying that anecdotal evidence is more compelling that rigorous science. This, of course, makes no sense. The whole point of scientific rigor is for evidence to be more objective and reliable – to control for any many variables as possible. Anecdotes are unreliable because they do not control for any variables. Proponents of acupuncture are happy to cite scientific evidence when they think it supports their beliefs, but then will chuck science in favor of low quality anecdotes as needed.
Feingold finishes with the commonplace appeal to antiquity. The premise of this argument is that a treatment that has no real effect could not survive for thousands of years. History proves that this premise is false (see blood letting), and it also profoundly underestimates the human capacity for self-deception and therefore the need for scientific controls.
Conclusion
There is still no compelling evidence that there is any real effect to acupuncture. It didn’t have to turn out that way, but that is the way the scientific chips fell. The treatment also lacks plausibility (although I usually point out that something is happening, unlike homeopathy, and so there is the physical possibility of an effect), and in medicine you only get two strikes. No evidence and no plausibility means that you’re out.
But the disconnect continues. Proponents keep pretending that there is compelling evidence, or it has not been properly studied yet, or it does not have to be studied because historical anecdotes are enough – whichever argument suits the moment. Meanwhile the media keep breathlessly telling us that acupuncture is gaining ground, while the evidence is standing still.
The premise of SBM is that support and resources should follow scientific support. In the world of CAM, however, support follows belief, and the science seems to be an afterthought or, worse, an obstacle.
**This post was originally published at Science Based Medicine.**
