A remarkable article about homeopathy and immunisation entitled THE IMMUNISATION DILEMMA came to my attention recently. Its abstract promised: “evidence quantifying the effectiveness of vaccination and HP (homeoprophylaxis) will be examined. New international research describing and analysing HP interventions will be reported. An evidence-based conclusion will be reached.”
Sounds interesting? Let’s see what the article really offers. Here is the relevant text:
…evidence does exist to support claims regarding the effectiveness of homeopathic immunisation is undeniable.
I was first invited to visit Cuba in December 2008 to present at an international conference hosted by the Finlay Institute, which is a W. H. O.-accredited vaccine manufacturer. The Cubans described their use of HP to control an outbreak of leptospirosis (Weilʼs syndrome – a potentially fatal, water-born bacterial disease) in 2007 among the residents of the three eastern provinces which were most severely damaged by a severe hurricane – over 2.2 million people . 2008 was an even worse year involving three hurricanes, and the countryʼs food production was only just recovering at the time of the conference. The HP program had been repeated in 2008, but data was not available at the conference regarding that intervention.
I revisited Cuba in 2010 and 2012, each time to work with the leader of the HP interventions, Dr. Bracho, to analyse the data available. Dr. Bracho is not a homeopath; he is a published and internationally recognised expert in the manufacture of vaccine adjuvants. He worked in Australia at Flinders University during 2004 with a team trying to develop an antimalarial vaccine.
In 2012 we accessed the raw leptospirosis surveillance data, comprising weekly reports from 15 provinces over 9 years (2000 to 2008) reporting 21 variables. This yielded a matrix with 147 420 possible entries. This included data concerning possible confounders, such as vaccination and chemoprophylaxis, which allowed a careful examination of possible distorting effects. With the permission of the Cubans, I brought this data back to Australia and it is being examined by mathematicians at an Australian university to see what other information can be extracted. Clearly, there is objective data supporting claims regarding the effectiveness of HP.
The 2008 result was remarkable, and could only be explained by the effectiveness of the HP intervention. Whilst the three hurricanes caused immense damage throughout the country it was again worse in the east, yet the three homeopathically immunised provinces experienced a negligible increase in cases whilst the rest of the country showed significant increases until the dry season in January 2009 .
This is but one example – there are many more. It is cited to show that there is significant data available, and that orthodox scientists and doctors have driven the HP interventions, in the Cuban case. Many people internationally now know this, so once again claims by orthodox authorities that there is no evidence merely serves to show that either the authorities are making uninformed/unscientific statements, or that they are aware but are intentionally withholding information. Either way, confidence is destroyed and leads to groups of people questioning what they are told…
The attacks against homeopathy in general and HP in particular will almost certainly continue. If we can achieve a significant level of agreement then we would be able to answer challenges to HP with a single, cohesive, evidence-based, and generally united response. This would be a significant improvement to the existing situation.
Reference 7 is the following article: Bracho G, Varela E, Fernández R et al. Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control. Homeopathy 2010; 99: 156-166. The crucial bit if this paper are as follows:
A homeoprophylactic formulation was prepared from dilutions of four circulating strains of Leptospirosis. This formulation was administered orally to 2.3 million persons at high risk in an epidemic in a region affected by natural disasters. The data from surveillance were used to measure the impact of the intervention by comparing with historical trends and non-intervention regions.
After the homeoprophylactic intervention a significant decrease of the disease incidence was observed in the intervention regions. No such modifications were observed in non-intervention regions. In the intervention region the incidence of Leptospirosis fell below the historic median. This observation was independent of rainfall.
The homeoprophylactic approach was associated with a large reduction of disease incidence and control of the epidemic. The results suggest the use of HP as a feasible tool for epidemic control, further research is warranted.
The paper thus describes little more than an observational study. It shows that one region was less affected than another. I think it is quite clear that this could have many reasons which are unrelated to the homeopathic immunisation. Even the authors are cautious and speak in their conclusions not of a causal effect but of an “association”.
The 2012 data cited in the text remains unpublished; until it is available for public scrutiny, it is impossible to confirm that it is sound and meaningful.
Reference 8 refers to this article: Golden I, Bracho G. Adaptability of homœoprophylaxis in endemic, epidemic and stable background conditions. Homœopathic Links 2009; 22: 211-213. I have no access to this paper (if someone does, please fill us in) but, judging from both its title and the way it is described in the text, it does not seem to show reliable data about the efficacy of homeopathic immunisation.
So, is it true that “evidence does exist to support claims regarding the effectiveness of homeopathic immunisation”?
I do not think so!
Immunisation is by no means a trivial matter; wrong decisions in this area have the potential to cost the lives of millions. Therefore proofs of efficacy need to be published in peer-reviewed journals of high standing. These findings need then be criticised, replicated and re-criticised and re-replicated. Only when there is a wide consensus about the efficacy/safety or lack of efficacy/safety of a new form of immunisation, can it be generally accepted and implemented into clinical practice.
The current consensus about homeopathic immunisation is that it is nothing less than dangerous phantasy. Those who promote this quackery should be publicly exposed as charlatans of the worst kind.
Homeopathy is a deeply puzzling subject for many observers. Perhaps it gets a little easier to understand, if we consider the three main perspectives on homeopathy. For the purpose of this post, I take the liberty of exaggerating, almost caricaturizing, these perspectives in order to contrast them as clearly as possible.
THE SCEPTICS’ PERSPECTIVE
Sceptics take a brief look at the two main assumptions which underpin homeopathy (like cures like and potentiation/dilution/water memory) and henceforward are convinced that homeopathic remedies are pure placebos. Homeopathy flies in the face of science; if homeopathy is right, several laws of nature must be wrong, they love to point out. As this is most unlikely, they reject homeopathy outright, usually even without looking in any detail at what homeopaths consider to be evidence in support of their trade. If sceptics are forced to consider a positive study of homeopathy, they know before they have seen it that its results are wrong – due to an error caused by chance, faulty study design or fabrication. The sceptics’ conclusion on homeopathy: it is a placebo-therapy, no doubt about it; and further investment into research is a waste of scarce resources which must be stopped.
THE BELIEVERS’ PERSPECTIVE
The believers in homeopathy know from experience that homeopathy works. They therefore feel that they have no choice but to reject almost every word the sceptics might tell them. They cling on to the gospel of Hahnemann and elaborate on the modern but vague theories that might support the theoretical assumptions of homeopathy. They point to positive clinical trials and outcome studies, to 200 years of experience, and to the endorsement of homeopathy by VIPs. When confronted with the weaknesses of their arguments, they find even weaker ones, such as ‘much of conventional medicine is also not based on good evidence, and the mechanism of action of many mainstream drugs is also not fully understood’. Alternatively, they employ the phoniest argument of them all: ‘even if it works via a placebo effect, it still helps patients and therefore is a useful therapy’. When even this fails, they tend to resort to ad hominem attacks against their opponents. The believers’ conclusion on homeopathy: it is unquestionably a valuable type of therapy regardless of what anyone else might say; research is merely needed to confirm their belief.
THE PERSPECTIVE OF THE ADVOCATES OF EVIDENCE-BASED MEDICINE (EBM)
The perspective of EBM-advocates is pragmatic; they simply say: “show me the evidence!” If the majority of the most reliable clinical trials of homeopathic remedies (or anything else) suggests an effect beyond placebo, they conclude that they are effective. If that is not the case, they doubt the effectiveness. If the evidence is highly contradictory or incomplete, they are likely to advocate more rigorous research. Advocates of EBM are usually not all that concerned by the lack of plausibility of the interventions they evaluate. If it works, it works, they think – and if a plausible mechanism is currently not available, it might be found in due course. The advocates of EBM have no preconceived ideas about homeopathy. Their conclusion on homeopathy goes exactly where the available best evidence leads them.
The arguments and counter-arguments originating from the various perspectives would surely continue for another 200 years - unless, of course, two of the three perspectives merge and arrive at the same or very similar conclusions. And this is precisely what has now happened. As I have pointed out in a recent post, the most thorough and independent evaluation of homeopathy according to rigorous EBM-standards has concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”
In other words, two of the three principal perspectives have now drawn conclusions which are virtually identical: there is a consensus between the EBM-advocates and the sceptics. This isolates the believers and renders their position no longer tenable. If we furthermore consider that the believers are heavily burdened with obvious conflicts of interest, while the other two groups are by definition much more independent and objective, it appears more and more as though homeopathy is fast degenerating into a cult characterised by the unquestioning commitment and unconditional submission of its members who are too heavily brain-washed to realize that their fervour has isolated them from the rational sections of society. And a cult is hardly what we need in heath care, I should think.
It seems to me therefore that these intriguing developments might finally end the error that homeopathy represented for nearly 200 years.
Progress at last?
THERE WILL NEVER BE AN ALTERNATIVE CANCER CURE
This statement contradicts all those thousands of messages on the Internet that pretend otherwise. Far too many ‘entrepreneurs’ are trying to exploit desperate cancer patients by making claims about alternative cancer ‘cures’ ranging from shark oil to laetrile and from Essiac to mistletoe. The truth is that none of them are anything other than bogus.
Why? Let me explain.
If ever a curative cancer treatment emerged from the realm of alternative medicine that showed any promise at all, it would be very quickly researched by scientists and, if the results were positive, instantly adopted by mainstream oncology. The notion of an alternative cancer cure is therefore a contradiction in terms. It implies that oncologists are mean bastards who would, in the face of immense suffering, reject a promising cure simply because it did not originate from their own ranks.
BUT THAT DOES NOT NECESSARILY MEAN THAT ALTERNATIVE CANCER TREATMENTS ARE USELESS
So, let’s forget about alternative cancer ‘cures’ and let’s once and for all declare the people who sell or promote them as charlatans of the worst type. But some alternative therapies might nevertheless have a role in oncology – not as curative treatments but as supportive or palliative therapies.
The aim of supportive or palliative cancer care is not to cure the disease but to ease the suffering of cancer patients. According to my own research, promising evidence exists in this context, for instance, for massage, guided imagery, Co-enzyme Q10, acupuncture for nausea, and relaxation therapies. For other alternative therapies, the evidence is not supportive, e.g. reflexology, tai chi, homeopathy, spiritual healing, acupuncture for pain-relief, and aromatherapy.
So, in the realm of supportive and palliative care there is both encouraging as well as disappointing evidence. But what amazes me over and over again is the fact that the majority of cancer centres employing alternative therapies seem to bother very little about the evidence; they tend to use a weird mix of treatments regardless of whether they are backed by evidence or not. If patients like them, all is fine, they seem to think. I find this argument worrying.
Of course, every measure that increases the well-being of cancer patients must be welcome. But this should not mean that we disregard priorities or adopt any quackery that is on offer. In the interest of patients, we need to spend the available resources in the most effective ways. Those who argue that a bit of Reiki or reflexology, for example, is useful - if only via a non-specific (placebo) effects - seem to forget that we do not require quackery for patients to benefit from a placebo-response. An evidence-based treatment that is administered with kindness and compassion also generates specific non-specific effects. In addition, such treatments also generate specific effects. Therefore it would be a disservice to patients to merely rely on the non-specific effects of bogus treatments, even if the patients do experience some benefit from them.
ALTERNATIVE ‘PAMPERING’ AS A COMPENSATION FOR INADEQUACIES IN THE SYSTEM?
So, why are unproven or disproven treatments like Reiki or reflexology so popular for cancer palliation? This question has puzzled me for years, and I sometimes wonder whether some oncologists’ tolerance of quackery is not an attempt to compensate for any inadequacies within the routine service they deliver to their patients. Sub-standard care, unappetising food, insufficient pain-control, lack of time and compassion as well as other problems undoubtedly exist in some cancer units. It might be tempting to assume that such deficiencies can be compensated by a little pampering from a reflexologist or Reiki master. And it might be easier to hire a few alternative therapists for treating patients with agreeable yet ineffective interventions than to remedy the deficits that may exist in basic conventional care.
But this strategy would be wrong, unethical and counter-productive. Empathy, sympathy and compassion are core features of conventional care and must not be delegated to quacks.
Here is a quick reminder of some important things you should take care of before the year is out. Shops are still open; so hurry, there is no time to lose on the alternative path to holistic health.
1) Buy some Rescue Remedies
No matter whether your mother-in-law visits this Christmas or not, the ‘festive’ season can be extremely stressful. Think how often in the past a member of your family was next to a breakdown! Think of how often you felt like hitting the bottle and forgetting about the rest of the unthankful bunch. This year, you should be prepared; for just a little outlay, you can purchase these wonderful Bach Flower Remedies specifically designed to rid everyone of stress and disharmony.
2) Get yourself Prince Charles’ Detox Tincture
Some say that Christmas is the time of love, peace and quiet, but surely you were not born last Wednesday and know better: it is the time of over-indulgence. At the end of the holiday season your body will be as polluted as the toxic sewage of a Bayer Leverkusen. What you need now is detox!!! Luckily, the heir to the thrown has thought of us; his detox-tincture is just the ticket – best get two bottles, think of the looming New Year celebrations!
3) Homeopathic ‘Nux Vomica’
Alcohol hangovers are almost unavoidable during this time of the year. Based on the ‘like cures like’ principle, the homeopathic best-seller ‘Nux Vomica’ is every homeopath’s standard recommendation for this sort of thing – and we all know how valuable the advice of homeopaths invariably is.
4) Donation to ‘HOMEOPATHS WITHOUT BORDERS’
Christmas should also be the time for charity, and this fine organisation deservers your support! They do all sorts of splendid things; for instance, they make sure that AIDS-patients in Africa have enough trained homeopaths to cure then from the nasty infection once and for all without any side-effects whatsoever.
5) Support your local chiropractor
Chiropractors have had a really rough time of late: they lost a much publicised libel-case and their good reputation along with it. Now they are suffering badly from vicious in-fighting. Worst of all, the world is slowly realising that there is ‘NOT A JOT OF EVIDENCE’ for most of their therapeutic claims. You should therefore pop into your local chiro’s office and book the entire family for life-long ‘maintenance treatment’. It does not really work, but they so need your money.
6) Buy a few ear-candles
Who wants conventional candles on the Christmas tree? Ear-candles are so much more original! They are supposed to do all sorts of amazing things for your health plus they do look very becoming when worn during the festivities and make a nice alternative to those silly hats that you used to put on. An additional benefit is that your local health food shop selling the ear-candles desperately needs your trade – times have been hard, you know!
7) Protect yourself against the common cold
Echinacea is the product to buy for this purpose. Scientists still debate whether it works or not, but it would be a mistake to listen to these nit-picking pedants. Take Echinacea and take it generously, the herbal industry counts on you.
8) Give up smoking
Your acupuncturist is the person you need for meeting your perennial New Year’s target of stopping to smoke. Book now!!! By January, they will all be fully booked with people who are desperate to give up the filthy habit; they earn their living by pretending that regularly sticking a few needles in your skin makes smoking cessation a piece of cake.
9) Lose a few pounds
Look at you! The feasting has not even started properly, and you are already several pounds over your ideal weight. Luckily, the alternative medicine industry has dozens of slimming aids on offer. Do they work? You should not ask such impertinent questions – there are no guarantees in life, you know! But at the very minimum, you will lose quite a few £s.
Here are 3 more short pieces of alternative medicine satire. if you like them, please consider to send me your own short articles.
AT FAP No 7 (sent in by ‘Ex-Acupuncturist’)
Heroin junkies are now putting another type of needle in their body to get high… Acupuncture needles! Acupuncturists have long theorized that an endorphin release is part of the clinical effect of acupuncture. Endorphins are the body’s own painkillers. They are in a group of chemicals called endogenous opioids. While sceptics have pointed out that endorphin release is also a key part of the placebo effect, it seems that ancient Chinese wisdom wins this round of the battle.
“The key is to twirl the needle in the correct direction for each individual,” one experienced user reported. “In general, men get clockwise, women counter-clockwise, but it reverses depending on the phase of the moon and whether the kidney pulse on the wrist is floating or deep. It may sound strange, but once you hit the right point and twirl the right way, you’re talking to the rabbit on the moon for hours.”
Apparently, heroin-like effects aren’t the only drugs acupuncture can mimic. Homeless researcher William S. Burrows reports point combinations which replicate cannabis, magic mushrooms, and even methamphetamines. “We confirmed this with a double-blind test down in the park. I drew the point combinations and labelled them with codes, then taught a few volunteers how to do the needling without telling them what combinations mimic each drug. Then I hit the bar while they rolled dice and randomly did these combinations on hundreds of homeless addicts, who then were observed and interviewed by different volunteers who didn’t know what group they had been randomized to. The differences between the meth points and the horse points were pretty obvious by behaviour, but we also gathered more objective data such as blood pressure, pupil size, and pre- and post- treatment urinalysis results. Most of our volunteers are users of real drugs, but when you get the acupuncture right it the metabolites show up in urine.”
Science journal editor Dr. Edward Ernest was impressed. “This acupuncture research carried out by homeless drug addicts, literally under a bridge, is better and more convincing than all previous acupuncture research combined. What’s more impressive is that it’s being replicated as we speak in addicted populations around the world, all through grassroots efforts.”
When asked why his research was so well structured and recorded compared to previous acupuncture research, Burrows said, “I’m not sure, but it may have something to do with how important getting high is to addicts. Regular acupuncturists are just telling people they can treat normal pain and diseases, and many of those go away on their own. We are dealing with serious drug habits here, it’s not something to mess around with. Regular people can be fooled with post hoc reasoning, regression to the mean, and a good bedside manner. Junkies in withdrawal have a higher standard of evidence.”
While getting high with acupuncture is safer and less expensive than using black market drugs, public health officials are already warning users that familiar communicable disease dangers exist if needles are shared. “We are discussing setting up a free acupuncture needle exchange to reduce the risk of hepatitis and HIV transmission.”
AT FAP No 8 (by Edzard Ernst)
THE END OF EBM and the arrival of VBM
Inspired by a recent popular vote in Scotland on the need of having homeopathy free on the NHS, top-ranking health politicians from across the UK have met to discuss the implications of this intriguing and ground-breaking development. The politicians were taken by the idea of replacing evidence with a popular vote. They felt that they were much more familiar with the various ways to influence voters than with the often fiendishly complex issues of scientific evidence. “Everything becomes understandable and transparent with one single stroke”, one senior official commented, “what could be more logical than finally democratising health care? It was time anyway to break the dictatorship of science; as politicians, we cannot tolerate to be told by scientists what is right and wrong.”
The panel drew up plans to have all major health care decisions decided by popular vote. Pilot projects that followed this courageous move have already generated most encouraging results: diabetics voted to have free chocolate, claudicants opted for cheaper cigarettes, addicts wanted to legalise hard drugs and the entire population of Totness was in favour of replacing conventional by alternative medicine.
On the basis of these findings, the secretary for health issued a press release pointing out that innovations of this nature might look counter-intuitive to notoriously short-sighted medics but from a more realistic perspective, they do make a lot of sense: patients deserve to be given a choice; if many to the most desperately ill diabetics die early as a consequence, it might even be humane to let them end their suffering quickly and with dignity - and from a societal point of view, early fatalities mean significant cost-savings which will certainly free funds to improve the health of the rest of the nation. “I am sure that this innovation will win us votes”, one Tory health politician was quoted saying. A white paper was drawn up which suggests the nationwide implementation of these progressive concepts, and well-informed circles at Westminster indicate that David Cameron views the new ‘Vote-Based Medicine’ (VBM) as a possible solution to steer the NHS out of its current crisis.
AT FAP No 9 (by Edzard Ernst)
A bitter row has broken out in the US-based ‘Palmer Institute of Straight Chiropractic’ (PISC) over the interpretation of the results generated by the largest long-term study of chiropractic that has ever been initiated. The study in question, which had been funded by the NIH and several chiropractic bodies across the world, started recruiting in the 1970. Its was aimed at testing the effects of chiropractic maintenance treatment. Based on D D Palmer’s , the father of chiropractic, axiom that all diseases are caused by ‘subluxations of the spine’, chiropractic maintenance care is a method of regularly adjusting subluxations of healthy people before they can do any significant damage to health and well-being. Top officials of PICS had therefore concluded that regular adjustments would prevent illness and prolong life. The project was thus to administer maintenance care to 1000 volunteers for their entire life time and compare the mortality and morbidity of this cohort with the data from the US population at large.
So far, the findings of this study had been kept under tight wraps; the protocol foresaw that the first analysis should only be at the 40-year follow-up. Last months, however, the first preliminary analysis emerged at a closed meeting of the PISC in Devonport, US. A leaked note shows that, despite the large sample size and the sizable number of morbidity and mortality outcomes in the study cohort, the comparison with the general population did not demonstrate any significant differences; if anything, the incidence of neurological problems, e.g. stroke, in the experimental group seems unusually high.
As soon as the results were known to the PISC-officials, dramatically different interpretations of these findings emerged, our reporter was told:
- One group of chiropractors claimed the results were obviously rigged; some were sure that BIG PHARMA had bribed the researchers/statisticians to produce false negative findings. “It stands to reason”, one chiropractor from this camp was quoted saying, “just imagine what would happen, if the effectiveness of chiropractic maintenance care would become general knowledge; nobody would need the pharma-industry any more. It is therefore clear that they did everything in their power to supress the truth”
- The other group of chiropractors claimed that the maintenance treatment implemented in the study was not intensive enough to be effective. On average, every study participant had 1.6 sessions of spinal manipulation per week (the costs of these treatments were estimated at US$ 60 million across the study period). But these chiropractors argued that “subluxations occur much more frequently and need to be treated more regularly; we advocate daily sessions to be on the safe side - besides, this would be ever so good for the profession as a whole.”
So far none of the chiropractors who have commented on the results of this study considered that their original hypothesis was false, i.e. that subluxations might not be the cause of all human disease. When our reporter put this possibility to the president of PISC, the answer was prompt and abrupt: ” You must be kidding! That would mean that D D Plamer was wrong. This is not a realistic possibility at all. Chiropractors are foremost manipulators; we will now manipulate the data until they confirm Palmer’s theory.”
CAM-Cancer is short for a project entitled “Concerted Action for Complementary and Alternative Medicine Assessment in the Cancer Field”. Originally funded by the European Commission, it is now hosted by the National Information Center for Complementary and Alternative Medicine (NIFAB) at the University of Tromsø, Norway.
Our executive Committee is very international and, in my view, fairly balanced; it consists of the following experts:
- Prof Vinjar Fønnebø, The Norwegian National Research Center in CAM
- Prof Thomas Cerny, Kantonsspital St Gallen, Switzerland
- Prof Edzard Ernst, University of Exeter, UK
- Dr Markus Horneber, Department of Oncology/Hematology, Klinikum Nuernberg, Germany
- Dr Christine Paludan-Müller, Danish Cancer Society
Our work consists mainly of conducting and updating systematic reviews of treatments often used by cancer patients and providing them for free via the Internet. To date, we have concluded more than 60 such projects and they are all available for anyone to study. I have previously reported about our results in the area of herbal medicine. Today, I will briefly mention those on mind-body interventions.
The Internet is awash with information on the effectiveness of such treatments which is not always accurate, and even top-journals publish reviews which paint a rather optimistic picture: Mind-body therapies categorized as CAM could potentially serve as a positive platform from which providers could discuss CAM and even link survivor subgroups to services that may, at least, partly address unmet psychosocial needs. This would be especially relevant for survivor subgroups that have a cultural bias toward CAM. The mind-body therapies reviewed in this article have some supportive evidence and a rationale for use in cancer survivors. Although data on efficacy and mechanisms of action of mind-body therapies are incomplete and inconclusive, the potential benefits of using these therapies in survivor care plans warrant consideration.
By contrast, our reviews seem far less positive. Here are the key sentences describing the evidence of the four mind-body therapies that we at ‘CAM cancer’ have so far tackled.
- Based on one clinical trial and two pilot studies, it is not possible to draw conclusions about the effectiveness of autogenic therapy for people with cancer
- There is presently a lack of good quality, single-intervention trials, so it is not possible to draw clear conclusions about the efficacy of biofeedback for people with cancer
- Existing evidence suggests that hypnotherapy may reduce cancer therapy related pain, anticipatory nausea and vomiting, and anxiety
- There is insufficient evidence for the effectiveness of PMR for cancer patients suffering from pain, anxiety, depression, sleep disorders and chemotherapy-induced nausea
The question is, what precisely does that mean? I think this evidence is compatible with several interpretations:
- Mind-body therapies are generally over-rated but not really that helpful.
- They are effective, but the research is in its infancy and currently fails to document their value adequately.
- Some mind-body therapies are effective, while others are not.
At present, it is impossible to tell which interpretation is correct. What is clear, however, is the fact that ‘CAM-Cancer’ is a source that tries its utmost to inform people accurately while doing everything possible to minimise bias.
The NHS tells us that our “choices include more than just which GP or hospital to use. You also have choices about your treatment decisions…” In most other countries, similarly confusing statements about PATIENT CHOICE are being made almost on a daily basis, often by politicians who have more ambition to win votes than to understand the complex issues at hand. Consequently, patients and consumers might be forgiven to assume that PATIENT CHOICE means we are all invited to indulge in the therapy we happen to fancy, while society foots the bill. Certainly, proponents of alternative medicine are fond of the notion that the principle of PATIENT CHOICE provides a ‘carte blanche’ for everyone who wants it to have homeopathy, Reiki, Bach Flower Remedies, crystal healing, or other bogus treatments - paid for, of course, by the taxpayer.
Reality is, however, very different. Anyone who has actually tried to choose his/her hospital will know that this is far from easy. And deciding what treatment one might employ for this or that condition is even less straight forward. Choice, it turns out, is a big word, but often it is just that: a word.
Yet politicians love their new mantra of PATIENT CHOICE; it is politically correct as it might give the taxpayer the impression that he/she is firmly installed in the driving seat. Consequently PATIENT CHOICE has become a slogan that is used to score points in public debates but that, in fact, is frequently next to meaningless. More often than not, the illusion of being in control has to serve as a poor substitute for actually being in control.
To imply that patients should be able to choose their treatment has always struck me as a little naïve, particularly in the way this is often understood in the realm of alternative medicine. Imagine you have a serious condition, say cancer: after you have come over the shock of this diagnosis, you begin to read on the Internet and consider your options. Should you have surgery or faith healing, chemotherapy or homeopathy, radiotherapy or a little detox?
Clearly PATIENT CHOICE, as paid for by society, cannot be about choosing between a realistic option and an unrealistic one. It must be confined to treatments which have all been shown to be effective. Using scarce public funds for ineffective treatments is nothing short of unethical. If, for a certain condition, there happen to be 10 different, equally effective and safe options, we may indeed have a choice. Alas, this is not often the case. Often, there is just one effective treatment, and in such instances the only realistic choice is between accepting or rejecting it.
And, anyway, how would we know that 10 different treatments are equally effective and safe? After going on the Internet and reading a bit about them, we might convince ourselves that we know but, in fact, very few patients have sufficient knowledge for making complex decisions of this nature. We usually need an expert to help us. In other words, we require our doctor to guide us through this jungle of proven benefits and potential risks.
Once we accept this to be true, we have arrived at a reasonable concept of what PATIENT CHOICE really means in relation to deciding between two or more treatments: the principle of shared decision making. And this is a fundamentally different concept from the naïve view of those alternative medicine enthusiasts who promote the idea that PATIENT CHOICE opens the door to opting for any unproven or disproven pseudo-therapy.
To be meaningful, ethical and responsible, choice needs to be guided by sound evidence - if not, it degenerates into irresponsible arbitrariness, and health care deteriorates into some kind of Russian roulette. To claim, as some fans of alternative medicine do, that the principle of PATIENT CHOICE gives everyone the right to use unproven treatments at the expense of the taxpayer is pure nonsense. But some extreme proponents of quackery go even further; they claim that the discontinuation of payment for treatments that have been identified as ineffective amounts to a dangerous curtailment of patients’ rights. This, I think, is simply a cynical attempt to mislead the public for the selfish purpose of profit.
Postoperative ileus (POI), the phenomenon that after an operation the intestines tend to be inactive for a few days, can cause intense pain and thus contributes significantly to human suffering. It also prolongs hospital stay and increases the risks of post-operative complications. There is no known effective treatment for POI.
In China, POI is often treated with acupuncture, and due to this fact acupuncture became known in the West: James Reston, a journalist who accompanied Nixon on his first trip to China, had to have an appendectomy in a Beijing hospital, he subsequently suffered from POI, was treated with acupuncture and moxibustion, experienced symptom-relief, and subsequently wrote about it in the New York Times. This was the beginning of the present acupuncture-boom.
Since then, thousands of acupuncture trials have been published but, intriguingly, very few have tested the effectiveness of acupuncture for POI. Now researchers from the Sloan Kettering Cancer Center in New York have conducted a randomized, sham-controlled trial to test whether acupuncture reduces POI more effectively than sham acupuncture.
Ninety colon cancer patients undergoing elective colectomy were randomized to receive 30 min of true or sham acupuncture twice daily during their first three postoperative days. GI-3 (the later of the following two events: time that the patient first tolerated solid food, AND time that the patient first passed flatus OR a bowel movement) and GI-2 (the later of the following two events: time patient first tolerated solid food AND time patient first passed a bowel movement) were determined. Pain, nausea, vomiting, and use of pain medications were evaluated daily for the first three postoperative days. Eighty-one patients received the allocated intervention: 39 the true acupuncture and 42 the sham acupuncture. The mean time to GI-3 was 149 hours and 146 hours for the acupuncture group and the sham acupuncture group. No significant differences were found between groups for secondary endpoints.
The authors’ conclusion was clear: True acupuncture as provided in this study did not reduce POI more significantly than sham acupuncture.
So, did a mere misunderstanding start the present acupuncture boom? POI inevitably normalises with time. Did the journalist just imagine that acupuncture helped, while nature cured the condition? It would seem so, according to this study. But perhaps things are not just black or white. Almost at the same time as the New York trial, another study was emerged.
Researchers from Hong Kong conducted an RCT with 165 patients undergoing elective laparoscopic surgery for colonic and upper rectal cancer. Patients were assigned randomly to receive electroacupuncture (n = 55) or sham acupuncture (n = 55), once daily from postoperative days 1-4, or no acupuncture (n = 55). The primary outcome was time to defecation. Secondary outcomes included postoperative analgesic requirement, time to ambulation, and length of hospital stay. The results showed that patients who received electroacupuncture had a shorter time to defecation than patients who received no acupuncture (85.9 ± 36.1 vs 122.1 ± 53.5 h) and length of hospital stay (6.5 ± 2.2 vs 8.5 ± 4.8 days). Patients who received electroacupuncture also had a shorter time to defecation than patients who received sham acupuncture (85.9 ± 36.1 vs 107.5 ± 46.2 h). Electroacupuncture was more effective than no or sham acupuncture in reducing postoperative analgesic requirement and time to ambulation.
The Chinese researchers’ conclusion is equally clear: electroacupuncture reduced the duration of postoperative ileus, time to ambulation, and postoperative analgesic requirement, compared with no or sham acupuncture, after laparoscopic surgery for colorectal cancer.
The only other trial I know in this area failed to show that acupuncture shortens POI. What should we make of these data? A systematic review would be nice, of course, but, to the best of my knowledge, none is currently available.
Is this a question of everyone being able to pick and chose the evidence they like? Is it a question of who we trust, the researchers in New York or those in China? Is it a question of where the treatment was done authentically? Is it a question of critically analysing which study had the higher risks of bias? Or is it a question of simply saying that two negative studies are more than one positive trial?
Confused? Me too, a little!
Whatever answers we chose, several things seems fairly certain to me. It would be wrong to say that there is good evidence for acupuncture as a treatment of POI. And the acupuncture-boom that ensued after Reston’s article was to a very large degree built on a simple misunderstanding: POI is a condition that resolves literally into thin air whether we treat it or not.
Tai Chi, as we know it in the West, is said to promote the smooth flow of “energy” throughout the body by performing postures, slow meditative movements and controlled breathing. Tai Chi is also supposed to help increasing flexibility, suppleness, balance and coordination. According to enthusiasts, the smooth, gentle movements of Tai Chi aid relaxation and help to keep the mind calm and focused.
Tai Chi has become popular in Western countries and is being considered for a surprisingly wide range of conditions. The patient/consumer is taught to perform postures, slow meditative movements and controlled breathing. The concepts underlying Tai Chi are strange, but that does not necessarily mean that the treatment is not effective for certain illnesses or symptoms.
There has been a surprising amount of research in this area, and some studies have generated encouraging results. A recent study which is unfortunately not available electronically ( Wu, WF; Muheremu, A; Chen, CH; Liu, WG; Sun, L. Effectiveness of Tai Chi Practice for Non-Specific Chronic Low Back Pain on Retired Athletes: A Randomized Controlled Study. JOURNAL OF MUSCULOSKELETAL PAIN 2013, 21:1, p.37-45) tested the effectiveness of Tai Chi for chronic back pain. Specifically, the researchers wanted to determine whether regular Tai Chi practice is superior to other means of sports rehabilitation in relieving non-specific chronic low back pain [LBP] in a younger population. They randomized 320 former athletes suffering from chronic LBP into a treatment [tai chi practice] and several control groups [regular sessions with swimming, backward walking or jogging, or no such interventions]. At the beginning, middle, and end of a six-month intervention, patients from all groups completed questionnaires assessing the intensity of LBP; in addition, a physical examination was conducted.
After 3 and 6 months, no statistically significant difference in the intensity of LBP was demonstrated between the Tai Chi and swimming. However, significant differences were demonstrated between the Tai Chi and backward walking, jogging, and no exercise groups.
The authors’ concluded that “Tai chi has better efficacy than certain other sports on the treatment of non-specific chronic LBP.”
This is only the second RCT of Tai chi for back pain. The first such study consisted of 160 volunteers between ages 18 and 70 years with persistent nonspecific low back pain. The experimental group (n = 80) had 18 Tai Chi sessions over a 10-week period. The waitlist control group continued with their usual health care. Bothersomeness of symptoms was the primary outcome, and secondary outcomes included pain intensity and pain-related disability. Tai Chi reduced bothersomeness of back symptoms by 1.7 points on a 0-10 scale, reduced pain intensity by 1.3 points on a 0-10 scale, and improved self-report disability by 2.6 points on the 0-24 Roland-Morris Disability Questionnaire scale. The authors of this RCT concluded that a 10-week Tai Chi program improved pain and disability outcomes and can be considered a safe and effective intervention for those experiencing long-term low back pain symptoms.
My own team have conducted their fair share of Tai Chi research. Specifically,we have published several systematic reviews of Tai Chi as an adjunctive or supportive treatment of various conditions, and the conclusions (in italics) have been mixed.
DIABETES: The existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes.
HYPERTENSION: The evidence for tai chi in reducing blood pressure in the elderly individuals is limited.
BREAST CANCER: the existing trial evidence does not show convincingly that tai chi is effective for supportive breast cancer care.
IMPROVEMENT OF AEROBIC EXCERCISE CAPACITY: the existing evidence does not suggest that regular tai chi is an effective way of increasing aerobic capacity.
PARKINSON’S DISEASE: the evidence is insufficient to suggest tai chi is an effective intervention for Parkinson’s Disease.
OSTEOPOROSIS: The evidence for tai chi in the prevention or treatment of osteoporosis is not convincing.
OSTEOARTHRITIS: there is some encouraging evidence suggesting that tai chi may be effective for pain control in patients with knee OA.
RHEUMATOID ARTHRITIS: Collectively this evidence is not convincing enough to suggest that tai chi is an effective treatment for RA.
Finally, an overview over all systematic reviews of Tai Chi suggested that the only area where the evidence is convincing is the prevention of falls in the elderly.
I think, this indicates that we should not pin our hopes too high as to the therapeutic value of Tai Chi. In particular, for back pain, the evidence might be optimistically judged as encouraging, but it is by no means convincing; the effect size seems to be small and two studies are not enough to issue general recommendations. On the other hand, considering that there is so little to offer to back pain patients, I concede that this is an area that should be studied further. Meanwhile, one could argue that Tai Chi can be fun and is devoid of risks – so, why not give it a try?
The vexing question whether the acupuncture needle is as safe as most acupuncturists seem to believe has been raised several times before on this blog. Here is a new case-report by Japanese authors which sheds an interesting light on this issue.
A 62-year-old man was admitted to A+E complaining of dizziness and diaphoresis. He had received an acupuncture treatment in the sub-xyphoid area (lower 2 cm and left 1 cm point from the lower xyphoid process border) only about one hour ago. He had a history of cerebral infarction and atrial fibrillation, and the latter condition was treated with 2 mg warfarin per day. On admission, the acupuncture needle was still sticking in his sub-sternum.
His blood pressure was 80/50 mm Hg, and tachycardia with 110 beats/min was noted. The acupuncture-needle was duly removed, but the patient went into cardiac arrest and had to be resuscitated. Because his international normalized ratio was 1.99, 2 pints of fresh frozen plasma and 5 mg of vitamin K were administered at that stage. A transthoracic echocardiography revealed pericardial effusion with early diastolic collapse of the right ventricle. Emergency pericardiocentesis using a sub-costal approach was performed. After drainage of 500 mL of sanguineous effusion, the patient seemed to stabilize.
Two hours later, the drainage of pericardial effusion amounted to around 1000 mL, and cardiac arrest re-developed. After another resuscitation, an operation was performed under cardiopulmonary bypass (CPB). A median sternotomy allowed visualization of huge hematomas over the right atrium and ventricle. After the hematomas had been evacuated, pulsating blood loss from the marginal branch of the right coronary artery was identified. The vessel had been torn into pieces, and it was ligated which stopped the bleeding. Thereafter, the patient remained hemodynamically stable. Subsequently the patient made an uneventful recovery and, eventually, he was discharged without further complications.
The authors of this case-report conclude as follows: To our best knowledge, this appears to be the first case of an acupuncture-related coronary artery injury. The important causes of this unfortunate adverse event are a lack of anatomic knowledge and an incorrect application of the procedure. It can be avoided that acupuncture leads to cardiac tamponade like most serious complications….every acupuncturist should be aware of the possible and life-threatening adverse events and be adequately trained to prevent them.
In 2011, we published a review of all cases of cardiac tamponade after acupuncture. At the time, we found a total of 26 such incidences. In 14 patients, the complications were fatal. In most reports, there was little doubt about causality. We concluded that cardiac tamponade is a serious, often fatal complication after acupuncture. As it is theoretically avoidable, acupuncturists should be trained to minimize the risk.
Acupuncture-fans will, of course, claim (as before) that it is alarmist to go on about risks of acupuncture or alternative medicine which are so minute that they are dwarfed by those of conventional health care. And I will counter (as before) that it is never the absolute risk that counts, but that it is the risk benefit balance which defines the value of any therapeutic intervention. As long as we have no solid proof that acupuncture is more than a “theatrical placebo“, even a tiny risk weighs heavily and seems unacceptable.
But the true significance of this case-report lies elsewhere, in my view: risks of this nature can and should be avoided. The only way to achieve this aim is to train and educate acupuncturists properly. At present this does not seem to be the case, particularly in Asian countries where acupuncture is most popular. It is up to the acupuncture communities across the globe to get their act together.