MD, PhD, FMedSci, FSB, FRCP, FRCPEd

pseudo-science

The Rubicon Group (TRG) is a collaboration of chiropractic educational institutions, emerging educational efforts and interested parties. The seven institutional members include Barcelona College of Chiropractic (Barcelona, Spain); the Chiropraktik Akademie (Dresden, Germany); Life Chiropractic College West (San Francisco, California, USA); Life University (Atlanta, Georgia, USA); McTimoney College of Chiropractic (Abingdon, Oxfordshire, UK); New Zealand College of Chiropractic (Auckland, New Zealand); and Sherman College of Chiropractic (Spartanburg, South Carolina, USA).

TRG has issued the following statement:

Definition and Position Statement on the Chiropractic Subluxation

The term ‘subluxation’ has been used by the chiropractic profession for over a century.1, 2 It is an important element of chiropractic practice, embedded in legislation and regulation, and its clinical implications have been, and continue to be, scientifically explored.2, 3
The term subluxation, as used by chiropractors, is a researchable concept that is important to health and health care delivery.1, 2, 4 The need to properly define this entity has been widely recognized as a high priority within the profession, as evidenced by the number of groups and organizations who have offered definitions of subluxation.1, 2, 5-10

Many of the past definitions do not provide a testable definition of chiropractic subluxation.11 

Some do not reflect the current research that supports a neurologically-centered model of subluxation. 2 The Rubicon Group (TRG) has utilized the current available scientific evidence to define the chiropractic subluxation. Contemporary neurophysiological language and concepts, based on current scientific publications on the topic, have been used. As this definition is subject to ongoing scientific exploration that is likely to lead to new findings and understandings, modifications may be anticipated. However, this definition reflects what is currently known, and it is congruent with current neurophysiological scientific understanding.

“We currently define a chiropractic subluxation as a self-perpetuating, central segmental motor control problem that involves a joint, such as a vertebral motion segment, that is not moving appropriately, resulting in ongoing maladaptive neural plastic changes that interfere with the central nervous system’s ability to self-regulate, self-organize, adapt, repair and heal.”

(The Rubicon Group, May 2017.)

There are three key elements, namely:

A chiropractic subluxation often relates to the spine and its connecting structures. 1 Chiropractic subluxation assessment generally involves evaluating the pathophysiological consequences of the central segmental motor control problem; 4, 12 these may include pain, asymmetry, biomechanical or postural changes (such as changes in relative range of intervertebral motion), changes in tissue temperature, texture and/or tone, and other findings that can be identified using special tests. 12 Once identified, subluxations are corrected using a variety of techniques including high velocity low amplitude chiropractic adjustments, instrument assisted adjustments, and lower force manual techniques and approaches.13

A growing body of scientific evidence has demonstrated that spinal function impacts central neural function in multiple ways,3, 4, 14-19 and that improving spinal function has an impact on clinical outcomes.20-24 Scientists have known for several decades that neurons continuously adapt in structure and function in response to our ever-changing environment.25-27 This ability to adapt is known as ‘neural plasticity’,27 and it is now well understood that the central nervous system can reorganize in response to altered input.28-35 Examples of increased sensory input that can lead to neural plastic changes include repetitive muscular activity 29, 36-41, such as typing or playing the piano, or repeated tactile sensory input such as occurs with blind Braille readers.42 Similar central nervous system change or reorganization may take place due to a decrease in behavior or activity.+ 32, 43-49 Thus the concept, that alterations in paraspinal muscle function due to abnormal spinal movement patterns are capable of changing central neural function, is totally congruent with current neuroscience understanding, as well as current scientific findings.3, 4, 14-19
[references can be found in the original]

MY COMMENT:

Subluxation is not so much a ‘self-perpetuating motor control problem’ as a self-perpetuating money-maker for chiropractors, it seems to me. The history of the use of this term shows that chiropractors have changed its meaning each time they were unable to deny its nonsensicality. To throw subluxation over board is not an option because chiropractic is at its hear a subluxation cult.

Yet, we have repeatedly been told that chiropractors have all but given up the concept of ‘subluxation’. This is clearly not the case. The above statement of TRG speaks for itself, and so does a recent study showing that “the majority of [North American chiropractic] students would like to see an emphasis on correction of vertebral subluxation”. It is the correction of the non-existent subluxation that stimulates the cash flow of chiropractors, a fact known even to the novices of the cult.

The new definition, it seems to me, is little more than self-serving nonsense. Wikipedia – I know, it’s not always the most reliable source, but in this case it is miles better that TRG – has this to say about subluxation: “In chiropractic, vertebral subluxation is a supposed misalignment of the spinal column leading to a set of signs and symptoms sometimes termed vertebral subluxation complex. It has no biomedical basis and is categorized as pseudoscientific by leading authorities. Traditionally, the “specific focus of chiropractic practice” is the chiropractic subluxation and historical chiropractic practice assumes that a vertebral subluxation or spinal joint dysfunction interferes with the body’s function and its innate intelligence, as promulgated by D. D. Palmer, the inventor of chiropractic.”

Wikipedia furthermore mentions that “in 2015, 8 internationally accredited chiropractic colleges: AECC, WIOC, IFEC-Paris, IFEC-Toulouse, USD-Odense, UZ-Zurich, UJ-Johannesburg and Durban University of Technology made an open statement which included: “The teaching of the vertebral subluxation complex as a vitalistic construct that claims that it is the cause of disease is unsupported by evidence. Its inclusion in a modern chiropractic curriculum in anything other than an historic context is therefore inappropriate and unnecessary”.”

Subluxation currently divides the chiropractic profession as we have seen here, for instance. But it is certainly not a concept that most chiropractors have been wise enough to declare obsolete.

In my view, the website of ‘FOODS 4 BETTER HEALTH’ should be more aptly called FOOD FOR QUICKER DEATH. At least this is the conclusion that came to my mind after reading their post on ‘Apricot Seeds: Nutrition, Health Benefits, and Their Role in Cancer Treatment’.

Under the heading ‘Apricot Seeds for Cancer Treatment’, we find the following explanations:

“Laetrile is a drug made from amygdalin. Apple seeds, Lima beans, plums, and peaches also contain amygdalin. Although laetrile isn’t a vitamin, it is labeled as amigdalina B17 or vitamin B17.

Dr. Kanematsu Sugiura received highest honors from the Japan Medical Association for his outstanding contributions in cancer research. He found that laetrile prevented the spread of malignant lung tumors in 10 to 20% of laboratory mice. Meanwhile, the mice given plain saline showed that lung tumor spread in 80 to 90% of the subjects. The study shows that laetrile reduces the spread of cancer and isn’t a cure for cancer.

According to a study published in the Public Library of Science, amygdalin blocks the growth of bladder cancer cells. The researchers studied the growth, proliferation, clonal growth, and cell cycle progression.

According to another study published in the International Journal of Immunopharmacology, the viability of human cervical cancer HeLa cell line was significantly inhibited by amygdalin. The researchers found apoptosis in amygdalin-treated HeLa cells.

However, a study published in The New England Journal of Medicine showed no substantial benefit of amygdalin on cancer patients. In fact, the blood cyanide levels of patients who received the substance intravenously increased alarmingly. But, the levels were relatively low in patients who received an oral dose.

A study conducted in 2002 at the Kyung Hee University in Korea found amygdalin to be helpful in killing prostate cancer cells. A similar study conducted on rats also linked the compound with pain relief, thus decreasing pain in cancer patients.

Amygdalin is considered as an alternative treatment for cancer. Since research so far has shown mixed and inconclusive results, apricot seeds may be helpful in the treatment of cancer, but shouldn’t be the only means to treat cancer. It is best to use it as a supplement with other cancer medications.”

END OF QUOTE

Cancer patients who read this sort of thing – and sadly the Internet offers plenty more of such irresponsible texts – might well decide to try Laetrile or start regularly consuming apricot seeds instead of chemotherapy or other effective cancer treatments. This decision would almost certainly hasten their deaths for two reasons:

  • Amygdalin is NOT an effective treatment for cancer.
  • It is highly toxic and would almost certainly kill some patients after chronic use.

To state, as the author of the above article does, that “research so far has shown mixed and inconclusive results” is irresponsible. The only thing that matters and the only message relevant for vulnerable patients is this: RESEARCH HAS NOT SHOWN THAT THIS STUFF WORKS FOR CANCER.

Alternative medicine is deeply rooted in the notion of ‘detox’. This website is one of thousands and displays some of the issues in an exemplary fashion:

START OF QUOTES

…There are more than 80,000 chemicals used in the industrialized world. Accumulate enough of these toxins and you might suffer, at the very least, fatigue, headaches, muscle soreness, bloating, depression and, at the worst, chronic disease and cancer… This is why regular detoxification is so important in our modern world. It helps your body eliminate toxic waste stored in your tissues. Plus you’ll get:

  • More energy
  • Stronger immunity
  • Faster fat burning
  • Fewer allergies
  • Fewer aches and pains
  • Healthier skin, hair and nails

You’ll find plenty of detoxification kits – or “detox in a box” – at pharmacies and health-food stores. But there is little if any scientific evidence that any of these quick fixes work. Instead, you’re better off using natural detoxification methods that are safe and reliable. Here’s what I recommend:

Step 1: Live without Toxins

There are many natural ways to rid yourself of toxins to look and feel your best:

  • Limit your exposure to hormones. If you eat grain-fed meat, eat only lean cuts and trim off the fat. If you eat grass-fed beef, it’s okay to eat the fat – it’s good for you.
  • Reduce your intake of caffeine, grains, carbohydrates and sugar. They make it harder for your body to fully process estrogen.
  • Stretch and massage your limbs. This will release acids and toxins stored in your own tissues so your body can eliminate them.
  • Hit the sauna. Perspiring in the heat releases toxins through your skin.

Step 2: Eat Purifying Foods

Did you know there are everyday foods that act as detoxifiers to help your body discard built-up toxins? Foods rich in vitamin C like fruits, berries and fresh vegetables will help do the trick, along with fiber-rich nuts, seeds and grains.

Signs You Need to Detox

  • You have unexplained headaches or back pain
  • You have joint pain or arthritis
  • Your memory is failing
  • You’re depressed or lack energy
  • You have brittle nails and hair
  • You’re suffering from psoriasis
  • You have abnormal body odor, a coated tongue or bad breath
  • You’ve experienced an unexplained weight gain
  • You have frequent allergies

Grapefruit is another food that binds to toxins and helps flush them from your body. It contains a flavonoid called naringenin, a potent antioxidant that decreases your body’s insulin resistance to help prevent diabetes, and reprogram your liver to melt excess fat, instead of storing it.

Why is this important to detoxification? Because toxins tend to collect in the fat around your tissues, like your liver, and eating grapefruit will help you stop this process.

Another food that can help clean out your body is garlic. Garlic increases phagocytosis. This boosts the ability of your white blood cells to fight the effects of toxins in your body.

Eating three cloves of fresh garlic per day will help you detox. If you don’t like the smell of garlic, you can get odorless aged garlic supplements at any health food store.

There’s also chlorella. You can find in most health-food stores, and C. Pyreneidosa is the form with the best metal-absorbing properties.

Most people can tolerate high doses of it with great success. Take 1 gram with breakfast, lunch, and dinner. You can increase the dose to up to 3 grams 3 to 4 times a day.

Another option is fresh cilantro, one of the best detoxifiers for your central nervous system. It mobilizes so much mercury, it can’t always carry it out of the body fast enough. So use it in combination with chlorella.

Eat organic cilantro, make a pesto or tea, or buy a tincture. Take 2 drops 2 times a day before meals or 30 minutes after taking chlorella. Increase your dose to up to 10 drops three times a day.

Step 3: Cleanse Your Internal Organs

Herbs can help clear toxins from your bloodstream, restore liver function and help flush out your kidneys. Detoxifying your liver a couple of times a year can also lower your cholesterol.

Here’s a list of herbal products that work well:

Milk thistle – I recommend 200 mg in capsule form twice a day. Look for dried extract with a minimum of 80 percent silymarin – the liver-cleaning active ingredient.

Alfalfa – This herb has been known to lower cholesterol by 25 percent in lab animals. It’s a good source of protein, vitamins A, D, E, B-6 and K, calcium, magnesium, iron, potassium, trace minerals and digestive enzymes.

Dandelion – This root stimulates bile and acts as a diuretic for excess water. Asians use it to treat hepatitis, jaundice, swelling of the liver, and deficient bile secretion. Use 4-10 grams of the dried leaf or 4 to 10 milliliters (1:1) of fluid extract.

Sarsaparilla – This is one of my favorite teas. It tastes great and acts as an effective blood detox. Native Americans have used it as a restorative tonic for centuries. Use 1-4 grams of the dried root, or 8-12 milliliters (2 to 3 teaspoons) (1:1) liquid extract, or 250 milligrams (4:1) of solid extract.

Burdock Root – This ancient remedy is a diuretic and a diaphoretic. It increases urine and perspiration production by exercising and strengthening these natural purging systems.

Step 4: Cleanse Your Colon

For an effective, natural way to flush out your colon, find and take the following herbs in combination:

  • Cascara Sagrada bark
  • Aloe leaf
  • Marshmallow root
  • Flax seed
  • Rhubarb root
  • Slippery Elm bark

Take them all at once, but be careful not to take too much because you could get some gurgling and it could loosen up your stool. They’re pretty powerful when you use them in this combination.

Step 5: Rid Your Tissues of Heavy Metals

These two compounds will remove chemicals and keep your body clean and pure like it’s supposed to be.

DMSA – This is a compound that removes heavy metal toxins (its real name is meso-2, 3-dimercaptosuccinic acid, but forget that tongue twister… it’s known simply as DMSA).

DMSA has receptor sites that the toxins bind to. The toxins reside inside the cells of the body and DMSA cannot enter the cells. Instead glutathione (your body’s natural toxin remover) residing in the cell pushes the metals out of the cell, where they’re picked up by DMSA and excreted.

DMSA should be taken in on-again/off-again cycles – ideally, three days on and 11 days off because your body needs 11 days to regenerate its glutathione levels.

Activated Charcoal – This is a form of carbon that’s been processed into a fine, black powder. It’s odorless, tasteless, safe to consume and very potent.

In fact, you can take a small amount of charcoal and wipe out decades of toxic heavy metals like arsenic, copper, mercury and lead that have been building up in your body.

You can find activated charcoal in any health-food store. It’s relatively inexpensive and easy to take. Because it’s a powder, you can take it just like you would your favorite protein drink, mixed into a liquid.

Take 20-30 grams a day of powdered activated charcoal (in divided doses) mixed with water over a period of 1-2 weeks.

Step 6: Detoxify Naturally with Citrus Pectin

Modified citrus pectin is made from the inner peel of citrus fruits and is one of the most powerful detoxifying substances I’ve found in the world. It’s also been proven to work in human clinical studies.

In one U.S.D.A. study, scientists gave modified citrus pectin to people for six days and measured the amount of toxins excreted in their urine before taking it and 24 hours after taking it. Here’s what they found:

  • The amount of deadly arsenic excreted increased by 130 percent
  • Toxic mercury excreted increased by 150 percent
  • Cadmium excreted increased by 230 percent
  • Toxic lead excreted increased by 560 percent4

What’s great about modified citrus pectin is that while it eliminates toxic metals and pesticides, it doesn’t deplete your body of zinc, calcium or magnesium. However, consult your physician before taking modified citrus pectin capsules and caplets to make sure they are the kind used in clinical studies and the proper dosage.

END OF QUOTES

This text is so full of unproven notions, disproven theories, implausible assumptions and misunderstood science that I cannot possible address them all here (almost as bad as Prince Charles’ famous ‘detox tincture’). I will therefore only focus on the author’s final CITRUS PECTIN recommendation which apparently is even supported by real evidence. The study cited might have been this one:

This clinical study was performed to determine if the oral administration of modified citrus pectin (MCP) is effective at lowering lead toxicity in the blood of children between the ages of 5 and 12 years. Hospitalized children with a blood serum level greater than 20 microg/dL, as measured by graphite furnace atomic absorption spectrometry (GFAAS), who had not received any form of chelating and/or detoxification medication for 3 months prior were given 15 g of MCP (PectaSol) in 3 divided dosages a day. Blood serum and 24-hour urine excretion collection GFAAS analysis were performed on day 0, day 14, day 21, and day 28.  This study showed a dramatic decrease in blood serum levels of lead (P = .0016; 161% average change) and a dramatic increase in 24-hour urine collection (P = .0007; 132% average change). The need for a gentle, safe heavy metal-chelating agent, especially for children with high environmental chronic exposure, is great. The dramatic results and no observed adverse effects in this pilot study along with previous reports of the safe and effective use of MCP in adults indicate that MCP could be such an agent. Further studies to confirm its benefits are justified.

Apart from the fact that it was published in one of the most notorious altmed journals ever, one ought to mention that it has been rightly criticised for its many and fatal flaws:

• Although the trial was conducted at a university hospital, there is no mention of the study’s approval by an institutional review board  

• The study’s criteria for inclusion and exclusion were not noted.  Although the authors state the MCP product was used for other children not in the study, their results were not included because they did not fit the inclusion criteria. 

• The study had no control/placebo group, although the article states the study was conducted at a hospital that works with lead-poisoned individuals where it is reasonable to assume a group control would be available. 

• Aside from baseline blood levels, only discharge levels were reported.  Presumably, weekly measurements were taken in order to monitor progress and determine when to discharge, but that data was not reported.

There are one or two other human studies on this subject but all of them are of a similar calibre as the one above.

I think this story provides several important lessons:

  • the detox notion is hugely popular in alternative medicine;
  • it is alarmist and takes advantage of our fear to get poisoned by modern life;
  • it is packaged into sciency language in order to appear plausible to lay people;
  • one hardly needs to scratch the surface to find that the ‘science’ is, in fact, pseudoscience of the worst kind;
  • alternative detox thus turns out to be little more than a cunning but dishonest and unethical sales pitch.

If your life-style is unhealthy, don’t think that detox will help, but change your ways.

If the air that you breathe or the water that you drink are polluted, don’t think that detox is the solution, but punish the government that is responsible for these disasters and vote for someone more responsible.

Detox, as used in alternative medicine, is stupid, unethical nonsense promoted by charlatans of the worst kind; don’t fall for it!!!

How often have I pointed out that most studies of chiropractic (and other alternative therapies) are overtly unethical because they fail to report adverse events? And if you think this is merely my opinion, you are mistaken. This new analysis by a team of chiropractors aimed to describe the extent of adverse events reporting in published RCTs of Spinal Manipulative Therapy (SMT), and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.

The Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analysed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analysed using tests for equality of proportions with continuity correction.

Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.

The authors concluded that although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.

We conducted a very similar analysis back in 2012. Specifically, we evaluated all 60 RCTs of chiropractic SMT published between 2000 and 2011 and found that 29 of them did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred (which I find hard to believe since reliable data show that about 50% of patients experience adverse effects after consulting a chiropractor). Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors. Our conclusion was that adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The new paper suggests that the situation has improved a little, yet it is still wholly unacceptable. To conduct a clinical trial and fail to mention adverse effects is not, as the authors of the new article suggest, against current guidelines; it is a clear and flagrant violation of medical ethics. I blame the authors of such papers, the reviewers and the journal editors for behaving dishonourably and urge them to get their act together.

The effects of such non-reporting are obvious: anyone looking at the evidence (for instance via systematic reviews) will get a false-positive impression of the safety of SMT. Consequently, chiropractors are able to claim that very few adverse effects have been reported in the literature, therefore our hallmark therapy SMT is demonstrably safe. Those who claim otherwise are quite simply alarmist.

A recent post discussed a ‘STATE OF THE ART REVIEW’ from the BMJ. When I wrote it, I did not know that there was more to come. It seems that the BMJ is planning an entire series on the state of the art of BS! The new paper certainly looks like it:

Headaches, including primary headaches such as migraine and tension-type headache, are a common clinical problem. Complementary and integrative medicine (CIM), formerly known as complementary and alternative medicine (CAM), uses evidence informed modalities to assist in the health and healing of patients. CIM commonly includes the use of nutrition, movement practices, manual therapy, traditional Chinese medicine, and mind-body strategies. This review summarizes the literature on the use of CIM for primary headache and is based on five meta-analyses, seven systematic reviews, and 34 randomized controlled trials (RCTs). The overall quality of the evidence for CIM in headache management is generally low and occasionally moderate. Available evidence suggests that traditional Chinese medicine including acupuncture, massage, yoga, biofeedback, and meditation have a positive effect on migraine and tension headaches. Spinal manipulation, chiropractic care, some supplements and botanicals, diet alteration, and hydrotherapy may also be beneficial in migraine headache. CIM has not been studied or it is not effective for cluster headache. Further research is needed to determine the most effective role for CIM in patients with headache.

My BS-detector struggled with the following statements:

  • integrative medicine (CIM), formerly known as complementary and alternative medicine (CAM) – the fact that CIM is a nonsensical new term has been already mentioned in the previous post;
  • evidence informed modalities – another new term! evidence-BASED would be too much? because it would require using standards that do not apply to CIM? double standards promoted by the BMJ, what next?
  • CIM commonly includes the use of nutrition – yes, so does any healthcare or indeed life!
  • the overall quality of the evidence for CIM in headache management is generally low and occasionally moderate – in this case, no conclusions should be drawn from it (see below);
  • evidence suggests that traditional Chinese medicine including acupuncture, massage, yoga, biofeedback, and meditation have a positive effect on migraine and tension headaches – no, it doesn’t (see above)!
  • further research is needed to determine the most effective role for CIM in patients with headache – this sentence does not even make the slightest sense to me; have the reviewers of this article been asleep?

And this is just the abstract!

The full text provides enough BS to fertilise many acres of farmland!

Moreover, the article is badly researched, cherry-picked, poorly constructed, devoid of critical input, and poorly written. Is there anything good about it? You tell me – I did not find much!

My BS-detector finally broke when we came to the conclusions:

The use of CIM therapies has the potential to empower patients and help them take an active role in their care. Many CIM modalities, including mind-body therapies, are both self selected and self administered after an education period. This, coupled with patients’ increased desire to incorporate integrative medicine, should prompt healthcare providers to consider and discuss its inclusion in the overall management strategy. Low to moderate quality evidence exists for the effectiveness of some CIM therapies in the management of primary headache. The evidence for and use of CIM is continuously changing so healthcare professionals should direct their patients to reliable and updated resources, such as NCCIH.

WHAT IS HAPPENING TO THE BMJ?

IT USED TO BE A GOOD JOURNAL!

The BMJ has always been my favourite Medical journal. (Need any proof for this statement? A quick Medline search tells me that I have over 60 publications in the BMJ.) But occasionally, the BMJ also disappoints me a great deal.

One of the most significant disappointments was recently published under the heading of STATE OF THE ART REVIEW. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:

Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.

The full text of this article is such that I could take issue with almost every second statement in it. Obviously, this would be too long and too boring for this blog. So, to keep it crisp and entertaining, let me copy the (tongue in cheek) ‘letter to the editor’ some of us published in the BMJ as a response to the review:

“Alternative facts are fashionable in politics these days, so why not also in healthcare? The article by Chen and Michalsen on thebmj.com provides a handy set of five instructions for smuggling alternative facts into medicine.

1. Create your own terminology: the term ‘complementary and integrated medicine’ (CIM) is nonsensical. Integrated medicine (a hotly disputed field) already covers complementary and conventional medicine.

2. Pretend to be objective: Chen and Michalsen elaborate on the systematic searches they conducted. But they omit hundreds of sources which do not support their message, which cherry-picks only evidence for the efficacy of the treatments they promote.

3. Avoid negativity: they bypass any material that might challenge what they include. For instance, when discussing therapeutic risks, they omit the disturbing lack of post-marketing surveillance: the reason we lack information on adverse events. They even omit to mention the many fatalities caused by their ‘CIM’.

4. Create an impression of thoroughness: Chen and Michalsen cite a total of 225 references. This apparent scholarly attention to detail masks their misuse of many of they list. Reference 82, for example, is employed to back up the claim that “satisfaction was lowest among complementary medicine users with rheumatoid arthritis, vasculitis, or connective tissue diseases”. In fact, it shows nothing of the sort.

5. Back up your message with broad generalisations: Chen and Michalsen conclude that “Taken together, CIM has an increasing role in the management of chronic pain, but high quality research is needed”. The implication is that all the CIMs mentioned in their figure 1 are candidates for pain control – even discredited treatments such as homeopathy.

In our view, these authors render us a service: they demonstrate to the novice how alternative facts may be used in medicine.”

James May, Edzard Ernst, Nick Ross, on behalf of HealthWatch UK

END OF QUOTE

I am sure you have your own comments and opinions, and I encourage you to post them here or (better) submit them to the BMJ or (best) both.

Regular readers of this blog will have noticed: when homeopathy-fans run out of arguments, they tend to conduct an ‘ad hominem’ attack. They like to do this in several different ways, but one of the most popular version is to shout with indignation: YOU ARE NOT QUALIFIED!!!

The aim of this claim is to brand the opponent as someone who does not know enough about homeopathy to make valid comments about it. As this sort of thing comes up regularly, it is high time to ask: WHO ACTUALLY IS AN EXPERT IN HOMEOPATHY?

This seems to be an easy question to answer, but – come to think of it – it is more complex that one first imagines. Someone could be an expert in homeopathy in more than one way; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the regulation of homeopathy,
  • in the clinical use of homeopathy in human patients,
  • in the clinical use of homeopathy in animals,
  • in the use of homeopathy in plants (no, I am not joking!),
  • in basic research of homeopathy,
  • in clinical research of homeopathy.

This blog is almost entirely devoted to clinical research; therefore, we should, for the purpose of this post, narrow down the above question to: WHO IS AN EXPERT IN CLINICAL RESEARCH OF HOMEOPATHY?

I had always assumed to be such an expert – until I was accused of being a swindler and pretender, that is. I have no formal qualifications for practising homeopathy (and never claimed otherwise), and this fact has prompted many homeopathy-fans to claim that I am not qualified to comment on the value of homeopathy. Do they have a point?

Rational thinkers have often pointed out that one does not need such qualifications for practicing homeopathy. In many countries, anyone can be a homeopath, regardless of background. In all the countries I know, one certainly can practise homeopathy, if one is qualified as a doctor. Crucially, do you really need to know how to practice homeopathy for conducting a clinical trial or a systematic review of homeopathy? Homeopaths seem to think so. I fear, however, that they are wrong: you don’t need to be a surgeon, psychiatrist or rheumatologist to organise a trial or conduct a review of these subjects!

Anyway, my research of homeopathy is not valid, homeopaths say, because I lack the formal qualifications to call myself a homeopath. Let me remind them that I have:

  1. been trained by leading homeopaths,
  2. practised homeopathy for quite some time,
  3. headed a team of scientists conducting research into homeopathy,
  4. conducted several clinical trials of homeopathy,
  5. published several systematic reviews of homeopathy,
  6. no conflicts of interest in regards to homeopathy.

However, this does not impress homeopath, I am afraid. They say that my findings and conclusions about their pet therapy cannot be trusted. In their eyes, I am not a competent expert in clinical research of homeopathy. They see me as a fraud and as an impostor. They prefer the real experts of clinical research of homeopathy such as:

  • Robert Mathie
  • Jos Kleinjen
  • Klaus Linde

These three researchers who are fully accepted by homeopaths; not just accepted, loved and admired! They all have published systematic reviews. Intriguingly, their conclusion all contradict my results in one specific aspect: THEY ARE POSITIVE.

I do not doubt their expertise for a minute, yet have always found this most amusing, even hilarious.

Why?

Because none of these experts (I know all three personally) is a qualified homeopath, none of them has any training in the practice of homeopathy, none of them has ever practised homeopathy on human patients, none of them has even worked for any length of time as a clinician.

What can we conclude from these insights?

We could, of course, descend to the same level as homeopaths tend to do and conclude that homeopathy-fans are biased, barmy, bonkers, stupid, silly, irrational, deluded, etc. However, I prefer to draw a different and probably more accurate conclusion: according to homeopathy-fans, an expert in clinical research of homeopathy is someone who has published articles that are favourable to their trade. Anyone who fails to do likewise is by definition not competent to issue a reliable verdict about it.

Shiatsu is one of those alternative therapies where there is almost no research. Therefore, every new study is of interest, and I was delighted to find this new trial.

Italian researchers tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive one of the following treatments:

  1. shiatsu plus amitriptyline,
  2. shiatsu alone,
  3. amitriptyline alone

The treatment period lasted 3 months and the primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month.

After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline.

The results show that all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers and there was no between-group difference in the primary endpoint. Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month. Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment.

The authors concluded that shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study.

Yes, I would advocate great caution indeed!

The results could easily be said to demonstrate that shiatsu is NOT effective. There is NO difference between the groups when looking at the primary endpoint. This plus the lack of a placebo-group renders the findings uninterpretable:

  • If we take the comparison 2 versus 3, this might indicate efficacy of shiatsu.
  • If we take the comparison 1 versus 3, it would indicate the opposite.
  • If we finally take the comparison 1 versus 2, it would suggest that the drug was ineffective.

So, we can take our pick!

Moreover, I do object to the authors’ conclusion that “shiatsu is a safe”. For such a statement, we would need sample sizes that are about two dimensions greater that those of this study.

So, what might be an acceptable conclusion from this trial? I see only one that is in accordance with the design and the results of this study:

 

POORLY DESIGNED RESEARCH CANNOT LEAD TO ANY CONCLUSIONS ABOUT THERAPEUTIC EFFICACY OR SAFETY. IT IS A WASTE OF RESOURCES AND A VIOLATION OF RESEARCH ETHICAL.

On this blog, we have had (mostly unproductive) discussions with homeopath so often that sometimes they sound like a broken disk. I don’t want to add to this kerfuffle; what I hope to do today is to summarise  a certain line of argument which, from the homeopaths’ point of view, seems entirely logical. I do this in the form of a fictitious conversation between a scientist (S) and a classical homeopath (H). My aim is to make the reader understand homeopaths better so that, future debates might be better informed.

HERE WE GO:

S: I have studied the evidence from studies of homeopathy in some detail, and I have to tell you, it fails to show that homeopathy works.

H: This is not true! We have plenty of evidence to prove that patients get better after seeing a homeopath.

S: Yes, but this is not because of the remedy; it is due to non-specific effect like the empathetic consultation with a homeopath. If one controls for these factors in adequately designed trials, the result usually is negative.

I will re-phrase my claim: the evidence fails to show that highly diluted homeopathic remedies are more effective than placebos.

H: I disagree, there are positive studies as well.

S: Let’s not cherry pick. We must always consider the totality of the reliable evidence. We now have a meta-analysis published by homeopaths that demonstrates the ineffectiveness of homeopathy quite clearly.

H: This is because homeopathy was not used correctly in the primary trials. Homeopathy must be individualised for each unique patient; no two cases are alike! Remember: homeopathy is based on the principle that like cures like!!!

S: Are you saying that all other forms of using homeopathy are wrong?

H: They are certainly not adhering to what Hahnemann told us to do; therefore you cannot take their ineffectiveness as proof that homeopathy does not work.

S: This means that much, if not most of homeopathy as it is used today is to be condemned as fake.

H: I would not go that far, but it is definitely not the real thing; it does not obey the law of similars.

S: Let’s leave this to one side for the moment. If you insist on individualised homeopathy, I must tell you that this approach can also be tested in clinical trials.

H: I know; and there is a meta-analysis which proves that it is effective.

S: Not quite; it concluded that medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

If you call this a proof of efficacy, I would have to disagree with you. The effect was tiny and at least two of the best studies relevant to the subject were left out. If anything, this paper is yet another proof that homeopathy is useless!

H: You simply don’t understand homeopathy enough to say that. I tried to tell you that the remedy must be carefully chosen to fit each unique patient. This is a very difficult task, and sometimes it is not successful – mainly because the homeopaths employed in clinical trials are not skilled enough to find it. This means that, in these studies, we will always have a certain failure rate which, in turn, is responsible for the small average effect size.

S: But these studies are always conducted by experienced homeopaths, and only the very best, most experienced homeopaths were chosen to cooperate in them. Your argument that the trials are negative because of the ineffectiveness of the homeopaths – rather than the ineffectiveness of homeopathy – is therefore nonsense.

H: This is what you say because you don’t understand homeopathy!

S: No, it is what you say because you don’t understand science. How else would you prove that your hypothesis is correct?

H: Simple! Just look at individual cases from the primary studies within this meta-analysis . You will see that there are always patients who did improve. These cases are the proof we need. The method of the RCT is only good for defining average effects; this is not what we should be looking at, and it is certainly not what homeopaths are interested in.

S: Are you saying that the method of the RCT is wrong?

H: It is not always wrong. Some RCTs of homeopathy are positive and do very clearly prove that homeopathy works. These are obviously the studies where homeopathy has been applied correctly. We have to make a meta-analysis of such trials, and you will see that the result turns out to be positive.

S: So, you claim that all the positive studies have used the correct method, while all the negative ones have used homeopathy incorrectly.

H: If you insist to put it like that, yes.

S: I see, you define a trial to have used homeopathy correctly by its result. Essentially you accept science only if it generates the outcome you like.

H: Yes, that sounds odd to you – because you don’t understand enough of homeopathy.

S: No, what you seem to insist on is nothing short of double standards. Or would you accept a drug company claiming: some patients did feel better after taking our new drug, and this is proof that it works?

H: You see, not understanding homeopathy leads to serious errors.

S: I give up.

The aim of this pragmatic study was “to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone.”

Patients with allergic asthma were included in a controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months plus routine care, or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1–7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0–100). Outcome parameters were assessed at baseline and at 3 and 6 months.

A total of 1,445 patients were randomized and included in the analysis (184 patients randomized to acupuncture plus routine care and 173 to routine care alone, and 1,088 in the nonrandomized acupuncture plus routine care group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5–1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0–4.0]; mental 4.0 [2.1–6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group.

The authors concluded that in patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

We have been over this so many times (see for instance here, here and here) that I am almost a little embarrassed to explain it again: it is fairly easy to design an RCT such that it can only produce a positive result. The currently most popular way to achieve this aim in alternative medicine research is to do a ‘A+B versus B’ study, where A = the experimental treatment, and B = routine care. As A always amounts to more than nothing – in the above trial acupuncture would have placebo effects and the extra attention would also amount to something – A+B must always be more than B alone. The easiest way of thinking of this is to imagine that A and B are both finite amounts of money; everyone can understand that A+B must always be more than B!

Why then do acupuncture researchers not get the point? Are they that stupid? I happen to know some of the authors of the above paper personally, and I can assure you, they are not stupid!

So, why?

I am afraid there is only one reason I can think of: they know perfectly well that such an RCT can only produce a positive finding, and precisely that is their reason for conducting such a study. In other words, they are not using science to test a hypothesis, they deliberately abuse it to promote their pet therapy or hypothesis.

As I stated above, it is fairly easy to design an RCT such that it can only produce a positive result. Yet, it is arguably also unethical, perhaps even fraudulent, to do this. In my view, such RCTs amount to pseudoscience and scientific misconduct.

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