The fact that much of chiropractic might be bogus has frequently been discussed on this blog. A recent press-release provided me with more evidence for this notion. It proudly announced a new book entitled “Beyond the Back: The Chiropractic Alternative For Conditions Beyond Back Pain”
The text claimed that shortly after the launch, the book hit #1 on the Amazon.com best seller list out of all Chiropractor books and also reached #1 for the category of Holistic Medicine.
When I checked (22/12/2016), I was not able to confirm this statement: #47 in Kindle Store > Kindle eBooks > Medical eBooks > Alternative & Holistic > Holistic Medicine, #58 in Books > Medical Books > Allied Health Professions > Chiropractic. But let’s not be petty; let’s rather see what the book has to offer.
‘Beyond the Back’ focuses on how Chiropractic care can do so much more than just alleviate back pain, the press-release says. From avoiding knee surgery to resolving athletic injuries, chiropractic care allegedly is a 100% natural health solution for a wide variety of conditions… In fact, in some cases, chiropractors can help their patients get off medications entirely and even avoid surgery, the press-release continues.
In the book itself, the authors claim that chiropractic is effective for a multitude of conditions, including asthma and colic (in fact, the authors try to give the impression that chiropractic is a veritable panacea), and that there is sound evidence for all these indications from hundreds, if not thousands of studies. The authors make it very clear – even on the book cover – that chiropractic is not an adjunct to conventional healthcare but an alternative to it; an idea, of course, that goes back to the founding fathers of chiropractic. As if this were not enough, the book also promotes diagnostic techniques such as applied kinesiology.
Some commentators on this blog have argued that the chiropractic profession is in the midst of giving up much of the nonsense upon it was originally based and to which it has clung on for more than hundred years. This book, written by 9 US authors of the new generation of chiropractors, seems to demonstrate the opposite.
On Amazon, the book currently has one single customer review: Value information and an easy read! I am a strong believer of chiropractic and this makes it easy for me to share this info with my friends !
This comment is apt because it makes clear that chiropractic is a belief system. We must not expect rational thoughts or facts from what, in effect, is a religion for many. I can understand this in a way: belief can be a cosy shelter from the truth; it does not require much thinking; it hardly needs any learning, no changing of minds, etc. However, belief can never be a basis for good healthcare. In my view, ‘Beyond The Back’ provides a perfect example of that.
The common cold is one of the indications for which homeopathy is deemed to be effective… by homeopaths that is! Non-homeopaths are understandably critical about this claim, not least because there is no good evidence for it. But, hold on, there is a new study which might change all this.
This study was recently published in COMPLEMENTARY THERAPIES IN MEDICINE which is supposed to be one of the better journals in this area. According to its authors, it was conducted “to determine if a homeopathic syrup was effective in treating cold symptoms in preschool children.” Children diagnosed with an upper respiratory tract infection were randomized to receive a commercial homeopathic cold syrup containing allium cepa 6X, hepar sulf calc 12X, natrum muriaticum 6X, phosphorous 12X, pulsatilla 6X, sulphur 12X, and hydrastasis 6X or placebo. Parents administered the study medication as needed for 3 days. The primary outcome was change in symptoms one hour after each dose. Parents also assessed the severity of each of the symptoms of runny nose, cough, congestion and sneezing at baseline and twice daily for 3 days, using a 4-point rating scale. A composite cold score was calculated by combining the values for each of the four symptoms. Among 261 eligible participants, data on 957 doses of study medication in 154 children were analyzed. There was no significant difference in improvement one hour after the dose for any symptom between the two groups. Analysis of twice daily data on the severity of cold symptoms compared to baseline values found that improvements in sneezing, cough and the composite cold score were significantly greater at both the first and second assessments among those receiving the cold syrup compared to placebo recipients.
The authors concluded that the homeopathic syrup appeared to be effective in reducing the severity of cold symptoms in the first day after beginning treatment.
Where to start? There are so many problems with this study that I find it difficult to chose the most crucial ones:
- The study had a clearly defined primary endpoint; it was not affected by the homeopathic treatment which doubtlessly makes the study a negative trial. The only correct conclusion therefore is that THE HOMEOPATHIC SYRUP FAILED TO AFFECT THE PRIMARY OUTCOME MEASURE OF THIS STUDY. THEREFORE THE TRIAL DID NOT PRODUCE ANY EVIDENCE TO ASSUME THAT THE EXPERIMENTAL TREATMENT WAS EFFICACIOUS.
- I don’t think that many of the primary or secondary outcome measures are validated or reliable.
- All the positive results reported in the abstract and the article relate to secondary endpoints which are purely explanatory by nature. They should, in my view, not be mentioned in the conclusions at all.
- The fact that some results turned out to be positive can be explained by the fact that the investigators ran dozens of tests for statistical significance which means that, by simple chance, some will turn out to produce a positive result.
- A further explanation for the seemingly positive results might be the fact disclosed in the text of the article that the children in the homeopathy group received more conventional drugs than those in the placebo group.
- Whatever the reason for these positive results, they certainly had nothing to do with the homeopathic syrup.
- The study was funded by the company producing the syrup and for which one of the authors was employed as a consultant. This might be an explanation for the abominably poor science. In other words, this paper is not an exercise in testing a hypothesis but one in marketing.
While I might forgive the company for trying to maximise their sales figures, I do find it harder to forgive the authors, reviewers and editors for publishing such overtly false conclusions. In my view, they are all guilty of scientific misconduct.
Alternative medicine suffers from what might be called ‘survey overload’: there are far too much such investigations and most of them are of deplorably poor quality producing nothing of value except some promotion for alternative medicine. Yet, every now and then, one finds a paper that is worth reading, and I am happy to say that this survey (even though it has several methodological shortcomings) belongs in this category.
This cross-sectional assessment of the views of general practitioners towards chiropractors and osteopaths was funded by the Department of Chiropractic at Macquarie University. It was designed as a quantitative descriptive study using an anonymous online survey that included closed and open-ended questions with opportunities provided for free text. The target population was Australian general practitioners. Inclusion criteria included current medical registration, membership of the Royal Australian College of General Practitioners and currently practicing as a general practitioner in Australia. The data being reported here were collected between May and December, 2014.
There were 630 respondents to the online survey during this period representing a response rate of 2.6 %. Results were not uniform for the two professions. More general practitioners believed chiropractic education was not evidence-based compared to osteopathic education (70 % and 50 % respectively), while the scope of practice was viewed as similar for both professions. A majority of general practitioners had never referred a patient to either profession (chiropractic: 60 %; osteopathy: 66 %) and indicated that they would not want to co-manage patients with either profession. Approximately two-thirds of general practitioners were not interested in learning more about their education (chiropractors: 68 %; osteopaths: 63 %).
The authors concluded that this study provides an indication of the current views of Australian general practitioners towards chiropractors and osteopaths. The findings suggest that attitudes may have become less favourable with a growing intolerance towards both professions. If confirmed, this has the potential to impact health service provision. The results from this cross-sectional study suggest that obtaining representative general practitioner views using online surveys is difficult and another approach is needed to supplement or replace the current recruitment strategy.
The authors do not speculate on the reasons why the attitudes of general practitioners towards chiropractic and osteopathy might have become more critical. Therefore I decided to offer a few possibilities here. The more negative views could be due to:
- better education of general practitioners,
- tightening of healthcare budgets,
- recent ‘bad press’ and loss of reputation (for instance, the BCA’s libel action against Simon Singh),
- the work of sceptics in informing the public about the numerous bogus claims made by osteopaths and chiropractors,
- the plethora of overtly bogus claims which nevertheless continue to be made by these practitioners on a daily basis,
- a more general realisation that these therapies can cause very serious harm,
- a mixture of the above factors.
Whatever the reasons are, the finding that there now seems to be a growing scepticism (in Australia, but hopefully elsewhere as well) about the value of chiropractic and osteopathy is something that cheers me up no end.
You probably remember: the US Federal Trade Commission’s (FTC) has issued a statement announcing that unsupported claims for homeopathic remedies will be no longer allowed. Specifically, they said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.
Now the AMERICAN INSTITUTE OF HOMEOPATHY (AIH) has published a rebuttal. It is hilarious and embarrassing in equal measure. Here it is in full (I have only omitted their references – they can be seen in the linked original – and added footnotes in bold square brackets with my very short comments):
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November 30, 2016
The American Institute of Homeopathy applauds the Federal Trade Commission’s (FTC) goal of protecting the American public from false advertising claims, but in a recent circumstance we believe the FTC has overstepped its jurisdictional bounds and promulgated false information in what appears to be a bid to restrict health care choices  available to the American public.
In Response to the recent Enforcement Policy Statement1 and a Consumer Information Blog,2 both issued by the FTC on November 15, 2016, the American Institute of Homeopathy registers our strong concern regarding the content of the following inaccurate statements:
- “Homeopathy… is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms…”
Homeopathy is not based on a “view” or an opinion. It is based on reliable, reproducible, clinically acquired, empiric evidence  gathered through two centuries of corroborated data, assisted by thousands of practitioners worldwide , demonstrating the actions of different medicinal substances in living systems, aka: the science of homeopathy. In fact, the homeopathic scientific community were pioneers of the modern scientific method including the widespread adoption of blinded and placebo controlled studies in 1885 , decades before conventional medicine.3
Homeopathy is not based on a theory or on conjecture, but on principles that have been confirmed by long-studied clinical data, meticulously gathered and analyzed over many years .
- “Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.”
While the dilution and succussion process of formulating homeopathic medicines does reduce the concentration (and the toxicity) of the original substances, detectable amounts of these materials remain quantifiable in the form of nanoparticles  dispersed throughout.4 Multiple independent laboratories, worldwide have confirmed that these nanoparticles persist,5 and that they are biologically active.6 Many other homeopathic products (particularly those sold OTC and described as “low potency”) have dilute amounts of the original substance  that remain chemically detectable by straightforward titration.
- “…homeopathic product claims are not based on modern scientific methods…”
This statement is false and misleading. The active ingredients within most OTC homeopathic products have hundreds or thousands of case reports from physicians who have used these medicines . These reports of direct clinical experiences establish a collective, real-world dataset that demonstrates which conditions have been observed to respond to treatment. Such historical data is similar to the types of information used to demonstrate effectiveness for many conventional OTC medicines on the market today .
The Homeopathic Pharmacopeia Convention of the United States (HPCUS) maintains a formulary describing the appropriate manufacturing standards for homeopathic medicines . Every homeopathic manufacturer member of the American Association of Homeopathic Pharmacists in good ethical standing complies with both manufacturing and labeling standards set by the HPCUS. Consumers should be cautious when using any products that are not distinguished by conformance with “HPUS” on the label.
- “…the case for efficacy is based solely on traditional homeopathic theories…”
This statement is false. Neither homeopathy nor homeopathic efficacy is based on any theories. Efficacy for various homeopathic medicines has been established by scientifically reproducible clinical empiric research evidence  and cured patient cases followed over many years . Homeopathy is an evidence-based medical subspecialty rooted in patient care.
- “…there are no valid studies using current scientific methods showing the product’s efficacy.”
While this statement may have limited accuracy with respect to some OTC products, it is false and misleading with respect to most homeopathic medicines listed in the Homeopathic Pharmacopeia of the United States. Hundreds of state-of-the-art double-blinded, randomized, placebo-controlled studies, many in peer-reviewed journals, demonstrate the superior efficacy of homeopathic medicines in a wide range of conditions, including asthma,7 depression and anxiety,8 chronic illness,9 allergic rhinitis,10 hypertension,11 headaches/migraines,12 sepsis,13 mild traumatic brain injury,14 otitis media,15 cancer,16 and many other conditions . The American Institute of Homeopathy maintains and continually updates an extensive database, available free to the public, with over 6,000 research articles .17
Multiple meta-analyses published in peer reviewed medical journals that conclude that homeopathic medicine effects are superior to placebo  and that additional study of this therapeutic system is warranted.18,19,20,21,22,23 To that end, we encourage the National Institutes of Health to reverse their current position of blocking funding for homeopathic trials.24
- “…marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading…”
The conclusion of whether a product has a “reasonable basis” is entirely irrelevant if that product has demonstrable clinical effectiveness. The important question, when it comes to homeopathy, is whether it is effective in clinical settings, not whether it has a “reasonable basis” for how it works. The mechanism by which homeopathy works differs from conventional medicines , but this fact does not make these products “misleading”.
Several recent class-action lawsuits brought against homeopathic manufacturers confirm that marketing practices were neither deceptive nor misleading .25
The FTC’s inability to formulate a reasonable basis for why homeopathic medicines work should not enter into any governmental enforcement policy statement. The FTC is not a medical organization, lacks expertise in interpreting scientific research , and is not qualified to make any comment on the validity of any field of medicine. To be less misleading, the FTC should exclude opinions from its policy statements.
- “Homeopathy: Not backed by modern science”
Homeopathy, as a system of medicine, does not fall under the purview of the FTC. Therefore, the FTC has been reckless in expressing an opinion of this magnitude. In this situation, the FTC’s comments can only be construed as being prejudicially biased and intentionally discriminatory against homeopathy. Such statements cause unwarranted harm to public trust and damage to a respected traditional system of medicine in the United States .
The American Institute of Homeopathy strongly objects to the FTC’s characterization of the entire field of homeopathic medicine as being without scientific evidence of efficacy. These comments are unqualified and wholly lacking in merit. The release of this Enforcement Policy Statement serves only to align the FTC with several recently released scientifically fraudulent  reports by a variety of pseudoscientists  and lowers the credibility of this valued consumer protection agency.
This type of misinformation should be embarrassing to a government organization striving to be nonpartisan and objective. The FTC owes an apology to the American Institute of Homeopathy as well as the many consumer groups that look toward this agency for fair and accurate information.
END OF QUOTE
1 In healthcare, choice must be restricted to treatments which demonstrably generate more good than harm.
2 The AIH seems to be unaware of the difference between the nature of evidence, anecdote and experience.
3 Fallacy – appeal to popularity.
4 The first randomized, placebo-controlled study of homeopathy was, in fact, published in 1835 – its results were negative.
5 Fallacy – appeal to tradition.
6 The nano-particle explanation of homeopathy is but a theory (at best).
7 Fallacy – appeal to tradition.
8 Fallacy – appeal to authority.
9 Really? Which ones? Examples would help, but I doubt they exist.
10 The proper manufacturing of nonsense must still result in nonsense.
11 See footnote number 2
12 Fallacy – appeal to tradition.
13 For all of these conditions, the totality of the reliable evidence fails to demonstrate efficacy.
14 In this context, only clinical trials are relevant, and their number is nowhere near 6,000.
15 Most of the independent systematic reviews fail to be positive.
16 The mechanism is well-known and is called ‘placebo-effect’.
17 Many class actions also went against the manufacturers of homeopathic preparations.
18 I assume they ‘bought in’ the necessary expertise.
19 Surely, the damage is only to the cash-flow of firms selling bogus products.
20 Really? Name the report you libel here or be quiet!
21 Name the individuals you attack in this way or be quiet!
I must say, I had fun reading this. In fact, I cannot remember having seen a document by an organisation of healthcare professionals which was so embarrassingly nonsensical that it becomes comedy gold. If one of my PhD students, for instance, had submitted such drivel, I would have had no choice but to fail him or her.
Having said that, I need to stress to the AIH:
FULL MARKS FOR AMUSEMENT!!!
On this blog, we have repeatedly discussed the issues around para-normal or spiritual healing practices. In one of these posts I concluded that these treatments are:
- utterly implausible
- not supported by good clinical evidence.
What follows seems as simple as it is indisputable: energy healing is nonsense and does not merit further research.
Yet both research and – more importantly – the practice of spiritual healing continue, not only in the developed world but even more so in poor and under-developed countries.
Traditional healers, known in Rwanda as Abarangi or Abacwezi claim to use their spiritual powers to heal sick patients. Recently, they urged their government to acknowledge them through proper regulation. Jean-Bosco Kajongi, the leader of the healers in Rwanda, said Abahereza are like doctors who have been selected by angels. “Umuhereza is someone who gets power from God to treat different diseases but particularly demonic possession such as ‘Amahembe’ and ‘Imandwa’. Sometimes, doctors detect something in the body, do surgery but find nothing. But Abarangi can identify the disease beforehand and heal it. Thus, we want to have legal personality and work with modern doctors because what we cure, they cannot even see it. Therefore, mortality rate would decrease.”
Abahereza claim to have God-given powers to heal any disease, provided that the patient has belief in their powers. Claudine Uwamahoro, a resident of Rulindo district is one of them. “Last year, I was transferred to Kanombe Military Hospital to have my leg cut off after they diagnosed me with cancer. Abarangi told me it was not cancer but rather ‘Imandwa.’ They treated me but I didn’t get healed immediately because I had not yet heeded God’s commandment because they do not use any medicines but only requires you to obey God and respect his commandments. Now my leg has been healed… Like Jesus came to save us so that we don’t perish, Umurangi also came so that we do not die of diseases that normal medicines cannot treat.”
Another patient agrees: “In 1983, I played football but later, Imandwa disabled me and my legs were paralyzed. I went to various hospitals and was given an assortment of medicines but they could not help. I always had fever; Doctors treated me but could not identify what kind of disease it really was. I even went to traditional healers but they didn’t have a solution. Pastors and priests prayed for me but in vain. Sorcerers also tried but failed. I was possessed by Imandwa and I was cured by Umurangi from Kirehe District. I believe that they have the power from God and when you respect their conditions, they treat and cure you completely.”
According to Alexia Mukahirwa, another witness, Umurangi is very powerful. “I was sick for 16 years. I went to different places and met many doctors. Some told me I had blood infection, others said it was stomach and intestinal infections. I consumed numberless medicines that never helped until I saw the power of Abarangi and believed them. Some people said that I had HIV/AIDS but it was not true. I only weighed 42 kilograms but now I have 68. Abarangi are powerful and may God bless them.”
James Mugabo, who is an “Umuhereza” or priest, said: “Before colonialism, people had their way of treating illness. But we have abandoned everything yet we should not.” The Director General of clinical services in the Ministry of Health responded by stating: “The law and policy are being drafted and will help us to know who does what kind of medicine and their identity. From that, we will know where to localize Abarangi in traditional or alternative.”
Hearing such things, we might smile and think ‘that’s Rwanda – this would not happen in developed countries’. But sadly, it does! These things happen everywhere. I know of healing ceremonies in the UK and the US that are embarrassingly similar to the ones in Rwanda – remember, for instance, the scenes seen on TV where Donald Trump was blessed by some evangelicals to receive the ability to win the election? And now they will probably claim that it worked!
Nothing to do with alternative medicine, you say? Perhaps this website on ‘spiritual homeopathy’ is more relevant then:
START OF QUOTE
What is spiritual homeopathy? It is based on the principle that “like cures like” and “wounds heal wounds” — the underlying wisdom of support groups. A Biblical story which illustrates this principle takes place on the ancient shepherding people’s journey through the desert. When they grew impatient and complained bitterly to Moses, God sent venomous snakes to bite the people. Many died. When the people confessed their sin, God told Moses to put a bronze snake on a pole. Those who were bitten and focused on the bronze snake did not die; they looked and lived.
Many years later Jesus said of his mission, “As Moses lifted up the serpent in the desert, so the Chosen One must be lifted up, so that everyone who believes on the Chosen One might have eternal life.” Jesus’ disciple Peter wrote, “By Christ’s wounds you are healed.” In “The Angel that Troubled the Waters,” Thornton Wilder wrote: “Without your wound where would your power be? … In love’s service only the wounded can serve.”
As the Thanksgiving and Christmas season approaches, spiritual homeopathy offers healing to all – because the Babe in the Manger is also the Wounded Healer
END OF QUOTE
I think I rest my case.
This is the title of a lecture I was asked to give yesterday to an audience of palliative cancer care professionals. During the last days, I have therefore thought about the Anderson-tale quite a bit. For those who don’t know the story (is there such a person?), it is a tale about two con-men who promise the emperor new clothes which, they claim, are invisible to anyone who is incompetent or stupid. When the Emperor parades before his subjects in his new clothes, no one dares to say that he is, in fact, naked. Finally, a child cries out, “But he isn’t wearing anything at all!”
The story is obviously a metaphor for a scenario where something is generally accepted as being good simply because nobody has the courage or insight to oppose popular opinion – nobody except a naïve child, that is. It is a fitting tale for alternative medicine and a superb one to depict my own personal history.
It got more fascinating the more I thought about it. As a metaphor for alternative medicine it offers at least four different perspectives:
- The quacks seem to get away with even the most obvious lies.
- The VIP is too gullible and vain to realise that he is being done.
- The sycophants are happy to play along because they hope to benefit from not speaking the truth.
- The child has not yet learnt how to ‘play along’ and therefore speaks the truth without a second thought.
The parallels to the current boom in alternative medicine are, I think, so striking that I do hardly need to explain them. The parallels to my own past, however, might require some explanation.
During the last 25 years, I have met more quacks making false claims than I care to remember. Some virtually sold the emperor clothes that were non-existent. One even offered him a report that suggested that the UK’s ailing healthcare system could be saved by maximizing the use of bogus therapies, such as homeopathy, for serious illnesses – more about that in a minute.
I even once had the honour to meet the emperor, our Queen – and it is not she who I here refer to. She was not at all gullible. The emperor I mean is actually our future emperor, the Queen’s son. He has provided us with ample evidence to doubt his intelligence, and it is he who has fallen for the con-men I refer to.
The sycophants are those ‘experts’ who Charles tends to assemble around him. They do know better, I think, but they do not tell him the truth because they know that people like Charles cannot tolerate any facts that fail to confirm his views. So they duly applaud even the silliest of notions hoping to keep their place in the entourage.
And the naïve child? Yes, of course, that’s me. When I arrived in Exeter 23 years ago, I did think that I was appointed to employ science as a tool to find the truth. Once I had done the research, I shouted: “But he isn’t wearing anything at all!” – metaphorically speaking, of course.
And that was something neither the emperor nor the sycophants could tolerate. When I said what had to be said about the ‘Smallwood Report’, the combined effort of the emperor and his sycophants put an end to my activities in Exeter.
Yes, in relation to alternative medicine, the story of THE EMPEROR’S NEW CLOTHES could be most interesting!
But did the palliative care experts invite me to tell it?
The more I thought about it, the more I doubted this.
Eventually, I arrived at the conclusion they wanted to hear about the evidence for or against alternative treatments for cancer. A pity really, because arguably the other aspect are much more entertaining.
Chiropractors (and other alternative practitioners) tend to treat their patients for unnecessarily long periods of time. This, of course, costs money, and even if the treatment in question ever was indicated (which, according to the best evidence, is more than doubtful), this phenomenon would significantly inflate healthcare expenditure.
This sounds perfectly logical to me, but is there any evidence for it? Yes, there is!
The WSJ recently reported that over 80% of the money that Medicare paid to US chiropractors in 2013 went for medically unnecessary procedures. The federal insurance program for senior citizens spent roughly $359 million on unnecessary chiropractic care that year, a review by the Department of Health and Human Services’ Office of Inspector General (OIG) found.
The OIG report was based on a random sample of Medicare spending for 105 chiropractic services in 2013. It included bills submitted to CMS through June 2014. Medicare audit contractors reviewed medical records for patients to determine whether treatment was medically necessary. The OIG called on the Centers for Medicare and Medicaid Services (CMS) to tighten oversight of the payments, noting its analysis was one of several in recent years to find questionable Medicare spending on chiropractic care. “Unless CMS implements strong controls, it is likely to continue to make improper payments to chiropractors,” the OIG said.
Medicare should determine whether there should be a cut-off in visits, the OIG said. Medicare does not pay for “supportive” care, or maintenance therapy. Patients who received more than a dozen treatments are more likely to get medically unnecessary care, the OIG found, and all chiropractic care after the first 30 treatment sessions was unnecessary, the review found. However, a spokesperson for US chiropractors disagreed: “Every patient is different,” he said. “Some patients may require two visits; some may require more.”
I have repeatedly written about the fact that chiropractic is not nearly as cost-effective as chiropractors want us to believe (see for instance here and here). It seems that this evidence is being systematically ignored by them; in fact, the evidence gets in the way of their aim – which often is not to help patients but to maximise their cash-flow.
Homeopathic products are safe!
At least this is what the homeopathy-lobby tries to make us believe. On this blog, we have repeatedly questioned this notion, and recently it was reported by several sources, for instance this website, that the FDA has taken action against one specific homeopathic remedy over safety concerns:
Some homeopathic tablets and gels aimed at helping to soothe babies’ teething pains may be dangerous for infants and toddlers, the FDA announced and stated they are now investigating reports of seizures in infants and children who were given homeopathic teething products: “consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation” after using homeopathic teething tablets and gels. The FDA also said it is not aware of any proven health benefit of using homeopathic teething tablets and gels.
Already in 2010, the FDA had issued a safety alert about a homeopathic teething tablet that contained belladonna. Belladonna, a poisonous plant that contains atropine. At high levels, atropine can be deadly. In homeopathy, it is used to treat redness and inflammation. At the time, the FDA found that the teething tablets contained inconsistent amounts of belladonna. The company that made the tablets, Hyland, subsequently recalled the product.
The full FDA statement is here:
The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.
Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”
The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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What follows is, I think, simple: homeopathic products are not necessarily safe, and there can be several reasons for that:
- they can be contaminated,
- they can be adulterated,
- some can contain high concentrations of toxic ingredients,
- most contain nothing active at all and are dangerous when mistaken for an effective therapy.
I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
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Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:
A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.
“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”
A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”
Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.
According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.
And what should we conclude from all this?
I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.
A website I recently came across promised to teach me 7 things about acupuncture. This sort of thing is always of interest to me; so I read them with interest and found them so remarkable that I decided to reproduce them here:
1. Addiction recovery
Acupuncture calms and relaxes the mind making it easier for people to overcome addictions to drugs, cigarettes, and alcohol by reducing the anxiety and stress they feel when quitting.
2. Helps the body heal itself
The body contains natural pain relief chemicals, such as endorphins and has an amazing capacity for self-healing. Acupuncture helps stimulate the natural healing mechanisms and causes the body to manufacture pain relieving chemicals.
3. Builds a stronger immune system
The body’s immune system is negatively affected by stress, poor diet, illness and certain medical treatments, but acupuncture targets the underlying imbalances naturally and helps it to regain balance.
4. Eliminate that killer hangover
While it may not have been the best choice to finish off that bottle of wine, acupuncture can help the body detox and flush out the morning side effects.
5. Mood stabilizer
If you find yourself snapping at friends, family, or co-workers for unexplained reasons, acupuncture can get to the root of the problem, find the imbalance and help your body return to a healthier state of mind.
6. Chronic stomach problems
Some people suffer from stomach problems and never find the cause. Acupuncture targets your whole body, including the digestive tract and helps it to work in harmony with the rest of the body’s systems.
7. Coping with death
Grief can have an overwhelming effect on the body and manifest itself physically. Acupuncture helps reduce the anxiety of dealing with loss and help you cope with the stress.
END OF QUOTE
The ‘7 things’ are remarkably mislabelled – they should be called 7 lies! Let me explain:
- There are several Cochrane reviews on the subject of acupuncture for various addictions. Here are their conclusions: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified. There is no clear evidence that acupuncture is effective for smoking cessation. There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
- Even if the ‘endorphin story’ is true (in my view, it’s but a theory), there is no good evidence that acupuncture enhances our body’s self-healing mechanisms via endorphins or any other mechanism.
- Stronger immune system? My foot! I have no idea where this claim comes from, certainly not from anything resembling good evidence.
- Acupuncture for hangover or detox? This is just a stupid joke with no evidential support. I imagine, however, that it is superb marketing.
- The same applies to acupuncture to ‘stabilize’ your mood.
- Unexplained stomach problems? Go and see a doctor! Here is the conclusion of a Cochrane review related to IBS which is one of the more common unexplained stomach complaint: Sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
- I am not aware of any good evidence to show that acupuncture could ease the grieving process; I even doubt that this would be such a good or desirable thing: grieving is a necessary and essential process.
So, what we have here are essentially 7 fat lies. Yes, I know, the literature and the internet are full of them. And I suspect that they are a prominent reason why acupuncture is fairly popular today. Lies are a major marketing tool of acupuncturists – but that does not mean that we should let them get away with them!
Bogus claims may be good for the cash flow of alternative practitioners, but they are certainly not good for our health and well-being; in fact, they can cost lives!!!
IN THIS SPIRIT, LET ME ADD SEVEN THINGS YOU DO NEED TO KNOW ABOUT ACUPUNCTURE
- Traditional acupuncture is based on complete hocus pocus and is therefore implausible.
- ‘Western’ acupuncture is based on endorphin and other theories, which are little more than that and at best THEORIES.
- Acupuncture is often promoted as a ‘cure all’ which is implausible and not supported by evidence.
- Meridians, acupoints chi and all the other things acupuncturists claim to exist are pure fantasy.
- For a small list of symptoms, acupuncture is backed up by some evidence, but this is less than convincing and could well turn out to rely on little more than placebo.
- The claim of acupuncturists that acupuncture is entirely safe is false.
- Acupuncture studies from China cannot be trusted.