MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

risk

Currently, over 50 000 000 websites promote alternative medicine, and consumers are bombarded with information not just via the Internet, but also via newspapers, magazines and other sources. This has the potential of needlessly separating them from their cash or even seriously harming their health. As there is little that protects us from greedy entrepreneurs and over-enthusiastic therapists, we should think about protecting ourselves. Here I will provide five simple tips that may fortify you against fake news in the realm of alternative medicine.

Imagine you read somewhere that the condition you are affected by is curable (or at least improvable) by THERAPY XY. It is only natural that you are exited by this news. Before you now rush to the next health shop or alternative medicine centre, it is worth asking yourself the following questions:

  • Is the claim plausible? As a rule of thumb, it is fair to say that, if it sounds too good to be true, it probably is too good to be true. Not so long ago, UK newspapers reported that a herbal mixture called ‘CARCTOL’ had been discovered to be an efficacious and safe cancer cure (before that, it was Essiac, shark cartilage, Laetrile and many more). I only needed a minimal amount of research to find that the claim had no basis in fact. Come to think of it, it is not plausible that any alternative therapy will ever emerge as a miracle cure for any condition, particularly a serious disease like cancer. It is also not plausible that a herbal mixture would ever prove to be a cure for a wide range of different cancers. The very idea of such ‘cures’ is a contradiction in terms. If an alternative therapy ever did turn out to be efficacious, it would become mainstream even before the clinical tests to prove its efficacy are fully concluded. The notion of an alternative cure presumes that conventional scientists and clinicians reject a treatment simply because it originated from the realm of alternative medicine. There is no precedent that this has ever occurred, and I am sure it will never happen in future.
  • What is the evidence for the claim? In the case of CARCTOL, the claim was based on a UK doctor apparently observing that, in several patients, tumours had been melting like butter in the sun after they took this herbal mixture. One particularly irresponsible headline read: “I’ve seen herbal remedy make tumours disappear, says respected cancer doctor.” This, however, is no evidence but mere anecdotes, and we confuse the two at our peril. Remember: the plural of anecdote is anecdotes, not evidence. With anecdotes, we can never be sure about cause and effect. Therapeutic claims must be based on good evidence, e.g. controlled clinical trials.
  • Who is behind the claim? In the UK, the CARCTOL claim emerged around 2004 and originated mainly from Dr Rosy Daniel. In the above newspaper article, she was called ‘a respected cancer doctor’. Personally, I do NOT ‘respect’  someone who makes claims of this nature without having good evidence. And a ‘cancer doctor’ is usually understood to be an oncologist; to the best of my knowledge, Dr Daniel is NOT an oncologist. In fact, she now calls herself a ‘Lifestyle and Integrative Medicine Consultant’. Faced with an important new health claim, one should always check who is behind it. Check out whether this person is reputable and free of conflicts of interest. An affiliation to a reputable university is usually more convincing than being a director of your own private heath centre.
  • Where was the claim published? The CARCTOL story had been published in newspapers – and nowhere else! Even today, there is only one Medline-listed publication on the subject. It is my own review of the evidence which, in 2004, concluded that “The claim that Carctol is of any benefit to cancer patients is not supported by scientific evidence.”   *** If important new therapeutic claims like ‘therapy xy cures cancer’ are reported in the popular media, you should always check where they were first published (or simply dismiss it without researching it). It is unthinkable that such an important claim is not made first in a proper, peer-reviewed article in a good medical journal. Go on ‘Medline’, conduct a quick search and find out whether the new findings have been published. If the claim does not come from peer-reviewed journals, forget about it. If it has been published in any journal that has alternative, complementary, integrative or similar terms in its name, take it with a good pinch of salt.
  • Is there money involved? In the case of CARCTOL, the costs were high. I was called once by a woman who had read my article telling me that she was pursued by the doctor who had treated her husband. Tragically, the man had nevertheless died of his cancer, and the widow was now pursued for £8 000 which she understandably was reluctant to pay. Many new treatments are expensive. So, high costs are not necessarily suspicious. Still, I advise you to be extra cautious in situations where there is the potential for someone to make a fast buck. Financial exploitation is sadly rife in the realm of alternative medicine.

A similar checklist originates from a team of experts. Researchers from Uganda, Kenya, Rwanda, Norway, and England, worked to identify the most important ideas a person would need to grasp thinking critically about health claims. They came up with excellent points:

  1. Just because a treatment is popular or old does not mean it’s beneficial or safe.
  2. New, brand-name, or more expensive treatments may not be better than older ones.
  3. Treatments usually come with both harms and benefits.
  4. Beware of conflicts of interest — they can lead to misleading claims about treatments.
  5. Personal experiences, expert opinions, and anecdotes aren’t a reliable basis for assessing the effects of most treatments.
  6. Instead, health claims should be based on high-quality, randomized controlled trials.

Alternative medicine can easily turn into a jungle or even a nightmare. Before you fall for any dubious claim that THERAPY XY is good for you, please go through the simple sets of questions above. This might protect you from getting ripped off or – more importantly – from getting harmed.

 

*** After this article had been published, I received letters from layers threatening me with legal action unless I withdrew the paper. I decided to ignore them, and no legal action followed.

The title of the article actually was ‘SIX REASONS TO TRY A WEATGRASS COLONIC’. I will only repeat parts of the introduction, but please do take the time to read the full text, particularly if you feel sad or depressed – it is hilarious!

START OF QUOTE

If you’ve ever had a colonoscopy, then you may be familiar with colonics. Colon cleansing is normally used to prepare for medical procedures. However, some alternative medicine practitioners might offer colon cleansing for other reasons, such as detoxification. During a colon cleanse, large amounts of water are flushed through the colon, along with other ingredients, such as herbs, teas, juice or coffee. This takes place with a tube that’s inserted into the rectum. In some cases, and depending on the colonic, smaller amounts of water along with other substances are left in the colon for about 30 minutes before being removed.

Wheatgrass is a humble weed that has a wide variety of health benefits for the body due to high concentrations of chlorophyll, active enzymes, vitamins and other nutrients. According to Israeli research on wheatgrass, lab studies suggest that it may have anticancer potential. In animal experiments, wheatgrass demonstrated possible benefits in cancer prevention and as an aid to cancer treatment — particularly chemotherapy. In clinical trials wheatgrass was found to improve chemotherapy and decrease chemotherapy-related side effects.

Wheatgrass has also been found to support the immune system and help repair damaged cells. It’s also shown promise for conditions such as:

  • Rheumatoid arthritis
  • Ulcerative colitis
  • Hematological diseases
  • Diabetes
  • Obesity
  • Oxidative stress (the body’s ability to repair damage)

Wheatgrass colonics cleanse and nourish the colon, according to digestive wellness center Vitallife. And effects are felt almost immediately. This is attributed to wheatgrass’s dense nutrient profile, which contains over 90 minerals, and the high absorption rate of the colon. Both factors allow for easy and fast entry into the bloodstream.

END OF QUOTE

The article motivated me to come up with my SIX REASONS TO AVOID A WHEATGRASS COLONIC. Here they are:

  1. The treatment is not effective.
  2. It is uncomfortable.
  3. It is not safe.
  4. It costs money.
  5. It has no plausibility.
  6. There are better therapeutic options for whatever condition you want to treat.

I know, some of my reasons are not entirely scientific or fully evidence-based. But, if you read the article which inspired me to write this post, you will discover, I am sure, that my version is a whole dimension better than the original.

Since more than 20 years, I have been writing about the risks of alternative therapies. One of my first papers on this issue was published in 1995 and focussed on acupuncture. Here is its abstract:

The use of acupuncture is widespread. The procedure is often claimed to be totally, or at least reasonably, safe. The published evidence regarding its potential risks is reviewed. The repeated and/or inappropriate use of an acupuncture needle carries the risk of infections. Amongst others, AIDS and hepatitis have been transmitted. Acupuncture needles may also traumatise tissues and organs. Pneumothorax is the most frequent complication caused in this way. Finally, needles may break and fragments can be dislodged into distant organs. A serious and more general concern related to the safety of acupuncture is the competence of the therapist, whether or not medically qualified. The “philosophy” of acupuncture is not in line with orthodox diagnostic skills; therefore acupuncturists can be dangerously unconcerned with diagnostic categories. Thus indirect risks might add significantly to the direct risks of acupuncture. It is concluded that the true risk of acupuncture cannot be estimated. Whatever its extent, it could and probably should be lowered by enforcing educational and clinical standards.

My reason for banging on about the potential harms (direct and indirect risks) of alternative medicine is fairly obvious: I want to alert healthcare professionals and consumers to the fact that these treatments may not be as harmless as they are usually advertised to be. Yet, I have often be called an alarmist fear-monger. In my view, nothing could be further from the truth.

Thinking about fear-mongering, I began to ask myself whether those who regularly accuse me are the ones guilty of the deed. Are alternative practitioners fear-mongers? Surely not all of them, but some clearly are. Here are a few of the strategies they use for their fear-mongering.

NON-EXISTING DIAGNOSES

Perhaps the most obvious way to instil fear into people is to tell them that they are affected by a disease or condition they do not have. Many alternative practitioners do exactly that!

  • A chiropractor might tell you that you have a subluxation in your spine.
  • A naturopath would inform you that your body is full of toxins.
  • An acupuncturist will tell you that your life energy is blocked.
  • A homeopath might warn you that your vital force is too low.

These diagnoses have one thing in common: they do not exist. They are figments of the therapist’s imagination. And they have another thing in common: the abnormalities need to be corrected, and – surprise, surprise – the very therapy that the practitioner specialises in happens to be just the ticket for that purpose.

  • The chiropractor will tell you that a simple spinal adjustment will solve the problem.
  • The naturopath will inform you that a bit of detox will eliminate the toxins.
  • The acupuncturist will tell you that his needles will de-block your chi.
  • The homeopath will persuade you that he can find the exact remedy to revive your vital force.

And there we have the third thing these diagnoses have in common: they are all treatable, will all result in a nice bill, and will all improve the cash-flow of the therapist.

MEDICALIZING TRIVIALITIES

But often, it is not even necessary for an alternative therapist to completely invent a diagnosis. Patients usually consult an alternative practitioner with some sort of symptom – frequently with what one might call a medical triviality that does not need any treatment at all but can be dealt with differently, for instance, by issuing some life-style advice or just simple re-assurance that nothing major is amiss. But for the fear-monger, this is not enough. He feels the need to administer his therapy, and for that purpose he needs to medicalize trivialities :

  • A low mood thus becomes a clinical depression.
  • A sore back is turned into a nasty lumbago.
  • A tummy upset morphs into a dangerous gastritis.
  • Abdominal unrest is diagnosed to be a leaky gut syndrome.
  • A food aversion turns into a food intolerance, etc., etc.

The common denominator is again the fact that fear is instilled into the patient. And again, a useless therapy is administered, if at all possible in the form of a lengthy series of treatments. This, of course, generates significant benefit – not therapeutic, but financial!

DEMONIZING CONVENTIONAL MEDICINE

But there is always the risk that the patient is wiser than expected. She might be so scared learning of her condition that she decides to see her doctor. That would mean a loss of income which has to be avoided! The trick to achieve this is usually not difficult: conventional healthcare professionals must be demonized.

  • They are not treating the root cause of the problem.
  • They are in the pocket of BIG PHARMA.
  • They prescribe medicines with terrible side-effects.
  • They have no idea about holism.
  • They never have enough time to listen, etc., etc.

I know, some of these criticisms are not entirely incorrect (for instance, many conventional medicines do have serious side-effects but, as I try to point out ad nauseam, we need to consider their risk/benefit balance). But that is hardly the point here; the point is to scare the patient off conventional medicine. Only a person who is convinced that the ‘medical mafia’ is out to get her, will prove to be a loyal customer of all things alternative.

DISEASE PREVENTION

And a loyal customer is someone who comes not just once or twice but regularly, ideally from cradle to grave. The way to achieve this ultimate stimulus of the practitioners cash flow is to convince the patient that she needs regular treatments, even when she feels perfectly alright. The magic word here is PREVENTION! The masters here are the chiropractors, I guess; they promote what they call ‘maintenance care’, i.e. the regular treatment of healthy individuals to keep their spines subluxation-free. It goes without saying that maintenance care is a money-making scam.

The strategy requires two little lies, but that’s forgivable considering the good cause, boosting the income of the practitioner:

  1. Conventional doctors don’t do prevention.
  2. The alternative treatment is an effective preventative.

The first statement can be shown to be an obvious lie. All we know about effective disease prevention today comes from conventional medicine and science; nothing originates from the realm of alternative medicine. Remarkably, the most efficacious preventative measure of all times, immunisation, is frequently defamed and neglected by alternative practitioners.

The second statement is a necessary lie; how else would a patient agree to pay regularly for the practitioner’s services? I am not aware of any alternative therapy that can effectively prevent any disease.

CONCLUSIONS

  • Some alternative practitioners regularly instil fear into consumers.
  • Several strategies are being used for this purpose.
  • They have the aim of maximising the therapists’ income.
  • Fear-mongering is unethical and despicable.
  • Pointing out that a certain therapy might fail to generate more good than harm is not fear-mongering.

Before starting to treat a patient, all health care professionals – including of course alternative practitioners – have to obtain informed consent. This is not optional but an ethical and legal imperative. Informed consent must usually include full information on:

  • the diagnosis
  • its natural history
  • the most effective treatment options available
  • the proposed therapy
  • its effectiveness
  • its risks
  • its cost
  • a rough treatment plan

Only when this information has been transmitted to and understood by the patient can informed consent be considered complete.

One could easily argue that, in alternative medicine, informed consent is a practical impossibility.

To explain why, let us consider two scenarios.

SCENARIO 1

A patient with fatigue and headaches consults a Reiki healer. The practitioner asks a few questions and proceeds to apply Reiki. The therapist has no means to obtain informed consent because:

  • he is not qualified to make diagnoses
  • he knows little about the natural condition of the patient
  • he is ignorant of the most effective treatment options
  • he is convinced that Reiki works but is unaware of the evidence

SCENARIO 2

A patient with fatigue and headaches consults a chiropractor. The chiropractor takes a history, conducts a physical examination, tells the patient that her headaches are due to spinal misalignments which he suggests to treat with spinal manipulations, and proceeds to apply his treatments. The chiropractor has no means to obtain informed consent because:

  • he has insufficient knowledge of other therapeutic options
  • he is biased as to the effectiveness of spinal manipulations
  • he believes that they are risk-free
  • he has an overt conflict of interest (he earns his money by applying his treatments)

In some respects, these might be extreme scenarios. They were chosen to explain why informed consent is rarely possible in the realm of alternative medicine. Put simply, informed consent requires knowledge that alternative practitioners almost never possess. I know this will sound chauvinistic, but it requires knowledge that normally only doctors have – I mean doctors who have been through medical school. Moreover, it requires a lack of financial interest such that the clinician is not in danger of loosing out on some income, if he advises his patient not to receive treatment from him. Finally, informed consent requires information about the treatment. Arguably, this should include explanations how it works. For many alternative therapies, this information is not available. If it is unavailable, informed consent is impossible.

If I am correct – and I am fully aware that many will think I am not – what implications would this have? If informed consent is usually not provided or even impossible, one cannot help but conclude that alternative medicine, as it is practised in most places today, is not ethical.

This study tested chondroitin sulfate 800 mg/day (CS) pharmaceutical-grade in the management of symptomatic knee osteoarthritis. It was designed as a prospective, randomised, 6-month, 3-arm, double-blind, double-dummy, placebo and celecoxib (200 mg/day)-controlled trial.  The primary endpoints were changes in pain on a Visual Analogue Scale (VAS) and in the Lequesne Index (LI). Minimal-Clinically Important Improvement (MCII), Patient-Acceptable Symptoms State (PASS) were used as secondary endpoints.

A total of 604 patients, diagnosed according to American College of Rheumalogy (ACR) criteria, were recruited in five European countries and followed for 182 days. CS and celecoxib showed a greater significant reduction in pain and LI than placebo. In the intention-to-treat (ITT) population, pain reduction in VAS at day 182 in the CS group (−42.6 mm) and in celecoxib group (−39.5 mm) was significantly greater than the placebo group (−33.3 mm) (p=0.001 for CS and p=0.009 for celecoxib). No difference observed between CS and celecoxib. Similar trend for the LI, as reduction in this metric in the CS group (−4.7) and celecoxib group (−4.6) was significantly greater than the placebo group (−3.7) (p=0.023 for CS and p=0.015 for celecoxib). Again, no difference was observed between CS and celecoxib. Both secondary endpoints (MCII and PASS) at day 182 improved significantly in the CS and celecoxib groups. All treatments demonstrated excellent safety profiles.
The authors concluded that a 800 mg/day pharmaceutical-grade CS is superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in symptomatic knee osteoarthritis (OA) patients. This formulation of CS should be considered a first-line treatment in the medical management of knee OA.

In my view, this is a good study with clear and useful results: CS seems to be efficacious and safe. Another recent study confirmed the superiority of CS over celecoxib at reducing cartilage volume loss in knee OA patients.

The current Cochrane review does not yet account for the new data; it concluded cautiously positive: A review of randomized trials of mostly low quality reveals that chondroitin (alone or in combination with glucosamine) was better than placebo in improving pain in participants with osteoarthritis in short-term studies. The benefit was small to moderate with an 8 point greater improvement in pain (range 0 to 100) and a 2 point greater improvement in Lequesne’s index (range 0 to 24), both seeming clinically meaningful. These differences persisted in some sensitivity analyses and not others. Chondroitin had a lower risk of serious adverse events compared with control. More high-quality studies are needed to explore the role of chondroitin in the treatment of osteoarthritis. The combination of some efficacy and low risk associated with chondroitin may explain its popularity among patients as an over-the-counter supplement.

The call for more high quality trials was justified but has now been answered. In my view, CS can be considered an evidence-based option in the management of OA.

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.

The website of ‘HOMEOPATHY 360’ has just published a new post offering a handy instruction for killing patients suffering from acute appendicitis. If you do not believe me – I don’t blame you, I too found it hard to believe – read this short excerpt advocating homeopathy for this life-threatening condition (for readers without a medical background: if acute appendicitis is not treated promptly, the inflamed appendix might burst, spilling faecal material into the abdominal cavity, resulting in a life-threatening peritonitis):

The post is entitled “A Cure of Acute Appendicitis Using Frequent Homeopathic Doses in Solution

Here is the abstract:

“Placing centesimal potencies in solution and prescribing them frequently for acute conditions is not widely practiced. It can be superior to dry doses in many cases, where a persistent mild medicinal action is preferred to a strong aggravation. By prescribing dissolved doses of Arnica Montana 1m, a case of acute appendicitis was cured quickly. This suggests that centesimal potencies given frequently in solution may be more efficacious, prompt and gentle than treatment with dry doses.”

Fascinating, isn’t it?

Here are more details demonstrating that the author has done his homework:

“When treating a patient with acute medical condi­tion, in certain cases we fail to cure. Even though our case taking, evaluation, analysis, remedy and potency selection seem correct. What is the cause? In the Organon 5th edition (1833) Dr. Hahnemann introduced olfaction and dissolved centesimal remedies as a new method of administering doses. Around the year 1840 Hahnemann began to introduce LM potencies into his practice. From 1840 to 1843 he used both centesimal and LM potencies side by side in medicinal solutions. By these methods he hoped to avoid unwanted aggravations and provide rapid cure.

In some acute cases the aggravation can be discouragingly pro­longed and often cannot be discerned from the patient’s own disease. Many times we change the original prescrip­tion which could very well have been the simillimum. In acute diseases, a dry dose will many times produce an un­necessary aggravation because of the patient’s increased susceptibility. I have much experience now with what I call a “watery dose.” To prepare it, one or two globules of size 10 are diluted in 15ml. of distilled water in which 5 drops of alcohol added with 20 to 30 succussions. From this solution 10 drops are added to another 15 ml of water, and from this solution 5 to 10 drops dose repeated according to the severity of the disease. In such diluted solutions the correct number of drops must be precise. Every time be­fore taking the dose the solution is succussed 5 to 10 times. The same solution can be used for several days or weeks. Hahnemann recommended using carefully measured and dosed solutions with sensitive patients. Many times I have used this method with great success. It is not necessary to take 4 oz. to 8 oz. of water, Just fifteen ml. of distilled water is sufficient. This technique of dosing is also known as a split dose because it uses one or two pills in a solution that is then split over several days or weeks.

The results using this type of dosing can be very dif­ferent from dry doses. There is continuous amelioration of the complaints without aggravation. This comes closer to the ideal of strengthening the weakened vital force than is seen when we simply produce a similar stronger artificial disease in the patient.”

The author also provides a detailed case history of a patient who survived this treatment (of course, without mentioning that acute appendicitis can, in rare cases, have a spontaneous recovery).

MY ADVICE:

I would not recommend Arnica or any other homeopathic remedy for routine use in acute appendicitis (or any other condition) – unless, of course, you want to kill a maximum number of your patients suffering from this medical/surgical emergency.

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.

The new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ have already been the subject of the previous post. Today, I want to have a closer look at a small section of these guidelines which, I think, is crucial. It is entitled ‘HARMS OF NONPHARMACOLOGIC THERAPIES’. I have taken the liberty of copying it below:

“Evidence on adverse events from the included RCTs and systematic reviews was limited, and the quality of evidence for all available harms data is low. Harms were poorly reported (if they were reported at all) for most of the interventions.

Low-quality evidence showed no reported harms or serious adverse events associated with tai chi, psychological interventions, multidisciplinary rehabilitation, ultrasound, acupuncture, lumbar support, or traction (9,95,150,170–174). Low-quality evidence showed that when harms were reported for exercise, they were often related to muscle soreness and increased pain, and no serious harms were reported. All reported harms associated with yoga were mild to moderate (119). Low-quality evidence showed that none of the RCTs reported any serious adverse events with massage, although 2 RCTs reported soreness during or after massage therapy (175,176). Adverse events associated with spinal manipulation included muscle soreness or transient increases in pain (134). There were few adverse events reported and no clear differences between MCE and controls. Transcutaneous electrical nerve stimulation was associated with an increased risk for skin site reaction but not serious adverse events (177). Two RCTs (178,179) showed an increased risk for skin flushing with heat compared with no heat or placebo, and no serious adverse events were reported. There were no data on cold therapy. Evidence was insufficient to determine harms of electrical muscle stimulation, LLLT, percutaneous electrical nerve stimulation, interferential therapy, short-wave diathermy, and taping.”

The first thing that strikes me is the brevity of the section. Surely, guidelines of this nature must include a full discussion of the risks of the treatments in question!

The second thing that is noteworthy is the fact that the authors confirm the fact I have been banging on about for years: clinical trials of alternative therapies far too often fail to mention adverse effects.  I have often pointed out that the failure to report adverse effects in clinical trials is an unacceptable violation of medical ethics. By contrast, the guideline authors seem not to feel strongly about this omission.

The third thing that is noteworthy is that the guidelines evaluate the harms of the treatments purely on the basis of the adverse effects reported in the clinical trials and systematic reviews included in their efficacy assessments. This is nonsensical for at least two reasons:

  1. The guideline authors themselves are aware that the trials very often fail to mention adverse effects.
  2. For any assessment of harm, one has to go far beyond the evidence of clinical trials, because trials tend to be too small to pick up rare adverse effects, and because they are always conducted under optimally controlled conditions where adverse effects are less likely to occur than in real life.

Together, these features of the assessment of harms explain why the guideline authors arrive at conclusions which are oddly misguided; I would even feel that they resemble a white-wash. Here are two of the most overt misjudgements:

  • no harms associated with acupuncture,
  • only trivial harm associated with spinal manipulations.

The best evidence we have today shows that acupuncture leads to mild adverse effects in about 10% of all cases and is also associated with very severe complications (e.g. pneumothorax, cardiac tamponade, infections, deaths) in an unknown number of patients. More details can be found for instance here, here, here and here.

And the best evidence available shows that spinal manipulation leads to moderately severe adverse effects in ~50% of all cases. In addition, we know of hundreds of cases of very severe complications resulting in stroke, permanent neurological deficits or deaths. More details can be found for instance here, here, here and here.

In the introduction, I stated that this small section of the guidelines is crucial.

Why?

The reason is simple: any responsible therapeutic decision has to be based not just on the efficacy of the treatment in question but on its risk/benefit balance. The evidence shows that the risks of some alternative therapies can be considerable, a fact that is almost totally neglected in the guidelines. Therefore, the recommendations of the new guidelines by the American College of Physicians entitled ‘Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians’ are in several aspects not entirely correct and need to be reconsidered.

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.

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