The Committees of Advertising Practice (CAP) write and maintain the UK Advertising Codes, which are administered by the Advertising Standards Authority. On their website, the CAP recently published an updated advertising code for naturopathy. As we have regularly discussed the fact that the public is being frequently misled in this area, I consider the code important in the context of this blog. I therefore take the liberty of repeating it here – not least in the hope that this helps preventing misinformation in the future [the numbers in square brackets refer to me footnotes below].
START OF QUOTE
What is Naturopathy?
Naturopathy is a holistic  approach to healthcare that uses a combination of one or more different disciplines (for example herbal medicine or hydrotherapy) and a healthy lifestyle  in order to gain and maintain a healthy body .
What claims are likely to be acceptable?
The promotion of a healthy  lifestyle is likely to acceptable as are claims that go no further than those commonly accepted for healthy  eating, sleeping well, taking exercise and the like.
What claims are likely to be problematic?
The ASA and CAP have not yet been provided with evidence which demonstrates that Naturopathy can be used to treat medical conditions (Rule 12.1). Therefore, any claims that go beyond accepted claims for a healthy  lifestyle are likely to be problematic  unless they are supported by a robust body of evidence. In 2013, the ASA ruled against claims on a marketer’s website which said that Naturopathy could be used to treat acute and chronic illness and disease because the marketer had not provided any evidence in support of their claims (CNM The College of Naturopathic Medicine Ltd, 13 March 2013).
What about serious medical conditions?
Claims to offer treatment on conditions for which medical supervision should be sought  are likely to be considered to discourage essential treatment unless that treatment is carried out under the supervision of a suitably qualified health professional (Rule 12.2).
END OF QUOTE
Naturopathy has been the subject of my posts before – see for instance here, here, here, here and here. Naturopathy can be dangerous to the point where it can kill the patient – see for instance here and here. Therefore it is important that advertising gets regulated. To make it very clear: the above statement by the CAP is, in my view, a step in the right direction, and I encourage alternative practitioners to look up the equivalent CAP documents for their specific therapy.
Having said that, I still feel the need to make a few comments:
- It is misleading to call naturopathy ‘holistic’. This is often factually incorrect and also gives the impression that conventional medicine is not holistic – see also here.
- Are we sure that all lifestyles promoted by naturopaths are, in fact, healthy?
- Maintaining a healthy body is naturopathy speak for DISEASE PREVENTION. Who decides what is effective prevention? On what evidence? How come many naturopaths are against the most effective means of prevention of all times – vaccination?
- Who decides what is ‘healthy’? On what evidence?
- Why ‘problematic’? Are they not wrong or bogus or false or fraudulent or criminal?
- Are there conditions for which medical supervision should not be sought? Which are they?
Not being a native English speaker, I was not entirely sure what precisely slapping means. A dictionary informed me that it stands for “hitting somebody/something with the flat part of your hand”. And ‘slapping therapy’? What on earth is that? It occurred to me that there might be several types of slapping therapy.
HITTING SOMEONE WHO DISAGREES
Yes, it might be therapeutic to do that! Imagine you discuss with someone and realize that you do not have very good arguments to defend an irrational position. Eventually, you are cornered and angry. All you can think of is to slap your opponent.
No, not very constructive, but all too human, I suppose.
This sort of thing has happened to me several times during discussions at conferences: my opponents went so mad that I saw them clinching their fists or raising their hands. Fortunately, I can run quite fast and (so far) always managed to avoid the impending physical violence.
INSULTING SOMEONE WHO DISAGREES
That sort of thing happens regularly. I have written posts about the phenomenon here, here, here and here, for instance. If you read the comments sections of this blog, you regrettably find plenty of examples.
If I am honest, I must admit that, on some occasions, I have in desperation joined into such mud-battles. I am not proud of it but sometimes it just happens. We are all just human, and it certainly feels therapeutic to be rude to someone who is a continuous and deplorable nuisance by hurling insults at opponents.
Having made this confession, I must stress (again) that, on this blog, we ought to avoid this sort of slapping therapy. In the long run, it is unhelpful and only escalates the aggression.
When I googled ‘slapping’ I was referred to all sorts of sleazy websites which were essentially displaying maso-sadistic pornography that involved one person slapping another for sexual pleasure. Personally, I do not get a kick out of this type of slapping therapy and find it sad that some people obviously do.
Paida is the form of slapping therapy that recently made headlines and which therefore prompted this post. Paida in Chinese means to slap your body. Sure enough, the TCM people have made it into an alternative treatment which is usually called SLAPPING THERAPY (what will they think of next? you may well ask!). Already the sexual version of slapping therapy was not really funny, but this certainly is where the satire stops!
Hongchi Xiao, a Chinese-born investment banker, popularised this treatment some time ago. It involves slapping the body surface with a view of stimulating the flow of ‘chi’. Slapping therapists – no, they are not called ‘slappers’!!! – believe that this ritual restores health and eliminates toxins. In fact, they claim that the bruises which patients tend to develop after their treatment are the visible signs of toxins coming to the surface.
The treatment is not based on evidence — I know of not even a single clinical trial showing that it works — and it is certainly not agreeable. But at least it’s safe! No, you’d be wrong to think so: if slapping therapy, or any other bizarre and useless intervention is being employed as a replacement for treating a serious condition, it inevitably becomes life-threatening.
Recently, it was reported that a woman from East Sussex died after receiving slapping therapy; other fatalities have been documented previously. The latest victim had been suffering from diabetes and was led to believe that Paida was an effective treatment for her condition. Consequently, she discontinued her medication, a decision which eventually killed her.
Deaths after apparently harmless alternative treatments are being reported with depressing regularity. However, much more often, the resulting harm is not quite so dramatic, simply because the conditions treated are fortunately not life-threatening. In such cases, the ineffectiveness of the treatment does not lead to disaster, but it nevertheless causes unnecessary expense and prolongation of suffering.
We live in a time where we are constantly being told, for instance by ‘experts’ like Prince Charles, that we ought to be respectful towards ancient traditions of healthcare. So, let’s be clear: I am all for respect towards other cultures, but in medicine there should be limits. I do not see any benefit in either respecting or implementing ancient, obsolete notions of life energies, meridians, toxins and other disproven assumptions of alternative practitioners. They originate from a pre-scientific era and have been disproven. They do not belong in modern treatment manuals; at best, they belong in the history books of medicine.
WHAT DOCTORS DON’T TELL YOU (WDDTY) is probably the most vile publication I know. It systematically misleads its readers by alarming news about this or that conventional treatment, while relentlessly promoting pseudoscientific non-sense. This article , entitled “MMR can cause skin problems and ulcers if your immune system is compromised” is a good example (one of a multitude):
The MMR vaccine can cause serious adverse reactions, researchers have admitted this week. The rubella (German measles) component of the jab increases the risk of infection from the rubella virus itself, and can cause serious skin inflammation and ulcers in anyone whose immune system is compromised.
The risk is highest among people with primary immunodeficiency diseases (PIDD), chronic genetic disorders that cause the immune system to malfunction.
Although the risk for people with compromised immune systems has been known, and is even included in the package inserts supplied with the vaccine, it was theoretical, say researchers from the Children’s Hospital of Philadelphia, who say they have uncovered “genuine evidence of harm.”
The researchers analysed the health profile of 14 people—four adults and 10 children—who suffered some form of a PIDD. Seven of them still had the rubella virus in their tissues, suggesting that their immune systems were too weak to get rid of the virus in the vaccine. The virus can damage skin cells and cause ulcers, and makes the person more susceptible to the actual rubella virus, the researchers say.
People with a poor immune system already have compromised T-cells—which are responsible for clearing viral infections—and the MMR makes the problem worse.
END OF QUOTE
And what is wrong with this article?
The answer is quite a lot:
- The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
- The research itself is not described in a way that it would be possible to evaluate.
- The sample size of what seems to have been a case-control study was tiny.
- The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
- I was not able to find the publication on Medline, based on the information given.
Collectively, these points render the article not just useless, in my view, but make it a prime example of unethical, unhelpful and irresponsible scaremongering.
Dietary and herbal supplements (DHS) are currently popular. They are being promoted as being natural and therefore safe – an assumption that is clearly wrong: some DHS can contain toxic substances or they might cause interactions with drugs or other DHS.
This study explored whether adverse events were actually associated with such interactions and examined specific characteristics among inpatient DHS users prone to such adverse events. It was designed as a cross-sectional survey of 947 patients hospitalized in 12 departments of a tertiary academic medical centre in Haifa, Israel. It evaluated the rate of DHS use among inpatients, the potential for interactions, and actual adverse events during hospitalization associated with DHS use. It also assessed whether DHS consumption was documented in patients’ medical files. Statistical analysis was used to delineate DHS users at risk for adverse events associated with interactions with conventional drugs or other DHS.
The results show that about half of all patients took DHS. In 17 (3.7%) of the 458 DHS users, an adverse event may have been caused by DHS-drug-DHS interactions. According to the Drug Interaction Probability Scale, 14 interactions “probably” caused the adverse events, and 11 “possibly” caused them. Interactions occurred more frequently in older patients (p = 0.025, 95% CI: 2.26-19.7), patients born outside Israel (p = 0.025, 95% CI: 0.03-0.42), those with ophthalmologic (p = 0.032, 95% CI: 0.02-0.37) or gastrointestinal (p = 0.008, 95% CI: 0.05-0.46) comorbidities, and those using higher numbers of DHS (p < 0.0001, 95% CI: 0.52-2.48) or drugs (p = 0.027, 95% CI: 0.23-3.77).
The authors concluded that approximately one in 55 hospitalizations in this study may have been caused by adverse events associated with DHS-drug-DHS interactions. To minimize the actual occurrence of adverse events, medical staff education regarding DHS should be improved.
This seems to be a good study and it generated interesting findings on an important topic.
Why do I have nevertheless a problem with it?
The answer is simple but not pleasant: very similar results have been published almost simultaneously in more than one journal. The link above is to an article in the BR J CLIN PHARMACOL of October this year. The following text is from the abstract of an article in INTERN EMERG MED also of October this year:
Of 927 patients who agreed to answer the questionnaire, 458 (49.4 %) reported the use of 89 different DHS. Potential DHS-DHS interactions were identified in 12.9 % of DHS users. Three interactions were associated with the actual occurrence of adverse events. Patients at risk of DHS-DHS interactions included females (p = 0.026) and patients with greater numbers of concomitant medications (p < 0.0001) and of consumed DHS (p < 0.0001). In 88.9 % of DHS users, DHS use was not reported in medical files and only 18 % of the DHS involved in interactions were documented. Potential DHS-DHS interactions are common in inpatients, and may lead to hospitalization or worsen existing medical conditions. The causal relationship between potential interactions and actual adverse events requires further study.
END OF QUOTE
And to my surprise, I also found a third article also from the October issue of INTERN EMERG MED reporting on this survey. Here is part of its abstract:
DHS users were determined via a questionnaire. The Natural Medicine database was used to search for potential DHS-drug interactions for identified DHS, and the clinical significance was evaluated using Lexi-interact online interaction analysis. Medical files were assessed for documentation of DHS use. Univariate and multivariate logistic regression analyses were used to characterize potential risk factors for DHS-drug interactions. Of 927 patients consenting to answer the questionnaire, 458 (49 %) reported DHS use. Of these, 215 (47 %) had at least one potential interaction during hospitalization (759 interactions). Of these interactions, 116 (15 %) were potentially clinically significant. Older age [OR = 1.02 (1.01-1.04), p = 0.002], males [OR = 2.11 (1.35-3.29), p = 0.001] and increased number of used DHS [OR = 4.28 (2.28-8.03), p < 0.001] or drugs [OR = 1.95 (1.17-3.26), p = 0.011] were associated with potential interactions in DHS users. Physicians documented only 16.5 % of DHS involved in these interactions in patients’ medical files. In conclusion, a substantial number of inpatients use DHS with potential interactions with concomitant medications. Medical staff should be aware of this, question patients on DHS usage and check for such interactions.
END OF QUOTE
What is the difference between the three articles? The first one in INTERN EMERG MED authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potential DHS-DHS interactions among inpatients”. The second one in INTERN EMERG MED also authored by Levy I, Attias S, Ben Arye E, Goldstein L, Schiff E evaluated “potentially dangerous interactions of DHS with prescribed medications among inpatients”. Finally the one in BR J CLIN PHARMACOL also authored by Levy I, Attias S, Ben-Arye E, Goldstein L, Schiff E assessed in addition the interactions between DHS and prescription drugs.
Dual publications are usually considered to be a violation of research ethics. Publication of different aspects of one single data-set in multiple articles is called ‘salami-slicing’ and is often considered to be poor form.
My question to you, the reader of this post, is: What type of scientific misconduct do we have here?
The risks of consulting a chiropractor have regularly been the subject of this blog (see for instance here, here and here). My critics believe that I am alarmist and have a bee in my bonnet. I think they are mistaken and believe it is important to warn the public of the serious complications that are being reported with depressing regularity, particularly in connection with neck manipulations.
It has been reported that the American model Katie May died earlier this year “as the result of visiting a chiropractor for an adjustment, which ultimately left her with a fatal tear to an artery in her neck” This is the conclusion drawn by the L.A. County Coroner.
According to Wikipedia, Katie tweeted on January 29, 2016, that she had “pinched a nerve in [her] neck on a photoshoot” and “got adjusted” at a chiropractor. She tweeted on January 31, 2016 that she was “going back to the chiropractor tomorrow.” On the evening of February 1, 2016, May “had begun feeling numbness in a hand and dizzy” and “called her parents to tell them she thought she was going to pass out.” At her family’s urging, May went to Cedars Sinai Hospital; she was found to be suffering a “massive stroke.” According to her father, she “was not conscious when we got to finally see her the next day. We never got to talk to her again.” Life support was withdrawn on February 4, 2016.
Katie’s death certificate states that she died when a blunt force injury tore her left vertebral artery, and cut off blood flow to her brain. It also says the injury was sustained during a “neck manipulation by chiropractor.” Her death is listed as accidental.
Katie’s family is said to be aware of the coroner’s findings. They would not comment on whether they or her estate would pursue legal action.
The coroner’s verdict ends the uncertainty about Katie’s tragic death which was well and wisely expressed elsewhere:
“…The bottom line is that we don’t know for sure. We can’t know for sure. If you leave out the chiropractic manipulations of her neck, her clinical history—at least as far as I can ascertain it from existing news reports—is classic for a dissection due to neck trauma. She was, after all, a young person who suffered a seemingly relatively minor neck injury that, unbeknownst to her, could have caused a carotid artery dissection, leading to a stroke four or five days later… Thus, it seems to be jumping to conclusions for May’s friend Christina Passanisi to say that May “really didn’t need to have her neck adjusted, and it killed her.” … Her two chiropractic manipulations might well have either worsened an existing intimal tear or caused a new one that led to her demise. Or they might have had nothing to do with her stroke, her fate having been sealed days before when she fell during that photoshoot. There is just no way of knowing for sure. It is certainly not wrong to suspect that chiropractic neck manipulation might have contributed to Katie May’s demise, but it is incorrect to state with any degree of certainty that her manipulation did kill her.”
My conclusions are as before and I think they need to be put as bluntly as possible: avoid chiropractors – the possible risks outweigh the documented benefits – and if you simply cannot resist consulting one: DON’T LET HIM/HER TOUCH YOUR NECK!
Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.
Yet acupuncture is precisely the therapy such patients might be tempted to employ.
Because irresponsible or criminally naïve acupuncturists advertise it!
Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….
I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:
Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.
In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:
Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.
However, this does not deter them to conclude on a positive note:
In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.
So, why do I find this irresponsibly and dangerously misleading?
Here a just a few reasons why this meta-analysis should not be trusted:
- There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
- The primary studies all look extremely weak; this means they are likely to be false-positive.
- They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
- All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.
My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.
I have blogged about the herbal antidepressant before; for instance about the fact that it can cause potentially dangerous herb-drug interactions. When taken alone, however, it seems to be both safe and efficacious in reducing the symptoms of depression. This notion has just been confirmed yet again.
A new systematic review evaluated St. John’s wort (SJW) for the treatment of Major Depressive Disorder (MDD). The objectives of this review were to (1) evaluate the efficacy and safety of SJW in adults with MDD compared to placebo and active comparator and (2) evaluate whether the effects vary by severity of MDD.
The authors searched 9 electronic databases and existing reviews to November 2014. Two independent reviewers screened the citations, abstracted the data, and assessed the risk of bias. They included randomized controlled trials (RCTs) examining the effect of at least a 4-week administration of SJW on depression outcomes against placebo or active comparator in adults with MDD. Risk of bias was assessed using the Cochrane Risk of Bias tool and USPSTF criteria. Quality of evidence (QoE) was assessed using the GRADE approach.
Thirty-five studies examining 6993 patients met inclusion criteria; 8 studies evaluated a SJW extract that combined 0.3 % hypericin and 1-4 % hyperforin. SJW was associated with more treatment responders than placebo (relative risk [RR] 1.53; 95 % confidence interval [CI] 1.19, 1.97; I(2) 79 %; 18 RCTs; N = 2922, moderate QoE; standardized mean differences [SMD] 0.49; CI 0.23, 0.74; 16 RCTs; I(2) 89 %, N = 2888, moderate QoE). Compared to antidepressants, SJW participants were less likely to experience adverse events (OR 0.67; CI 0.56, 0.81; 11 RCTs; moderate QoE) with no difference in treatment effectiveness (RR 1.01; CI 0.90, 1.14; 17 RCTs, I(2) 52 %, moderate QoE; SMD -0.03; CI -0.21, 0.15; 14 RCTs; I(2) 74 %; N = 2248, moderate QoE) in mild and moderate depression.
The authors concluded that SJW monotherapy for mild and moderate depression is superior to placebo in improving depression symptoms and not significantly different from antidepressant medication. However, evidence of heterogeneity and a lack of research on severe depression reduce the quality of the evidence. Adverse events reported in RCTs were comparable to placebo and fewer compared with antidepressants. However, assessments were limited due to poor reporting of adverse events and studies were not designed to assess rare events. Consequently, the findings should be interpreted with caution.
This is an excellent review from a reputable and independent team. The findings are therefore trustworthy.
Does that mean that we can now recommend SJW for patients suffering from depression?
Perhaps – but we need to keep an eye on the interaction issue. As a sole treatment, SJW is much safer than conventional antidepressants. But if a patient takes other medicines, we ought to be very careful.
Other currently unresolved issues are the questions of which extract and which dose. At present, there is not enough evidence to provide conclusive answers to either of these, and therefore the enthusiasm of many doctors for prescribing SJW is understandably limited.
Irrespective of these problems, I have to say that SJW is without question one of the biggest ‘success stories’ from the realm of alternative medicine. Pity that there are not more of them!
A new nationally representative study from the US analysed ∼9000 children from the Child Complementary and Alternative Medicine File of the 2012 National Health Interview Survey. Adjusting for health services use factors, it examined influenza vaccination odds by ever using major CAM domains: (1) alternative medical systems (AMS; eg, acupuncture); (2) biologically-based therapies, excluding multivitamins/multiminerals (eg, herbal supplements); (3) multivitamins/multiminerals; (4) manipulative and body-based therapies (MBBT; eg, chiropractic manipulation); and (5) mind–body therapies (eg, yoga).
Influenza vaccination uptake was lower among children ever (versus never) using AMS (33% vs 43%; P = .008) or MBBT (35% vs 43%; P = .002) but higher by using multivitamins/multiminerals (45% vs 39%; P < .001). In multivariate analyses, multivitamin/multimineral use lost significance, but children ever (versus never) using any AMS or MBBT had lower uptake (respective odds ratios: 0.61 [95% confidence interval: 0.44–0.85]; and 0.74 [0.58–0.94]).
The authors concluded that children who have ever used certain CAM domains that may require contact with vaccine-hesitant CAM practitioners are vulnerable to lower annual uptake of influenza vaccination. Opportunity exists for US public health, policy, and medical professionals to improve child health by better engaging parents of children using particular domains of CAM and CAM practitioners advising them.
The fact that chiropractors, homeopaths and naturopaths tend to advise against immunisations is fairly well-documented. Unfortunately, this does not just happen in the US but it seems to be a global problem. The results presented here reflect this phenomenon very clearly. I have always categorised it as an indirect risk of alternative medicine and often stated that EVEN IF ALTERNATIVE THERAPIES WERE TOTALLY DEVOID OF RISKS, THE ALTERNATIVE PRACTITIONERS ARE NOT.
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.
END OF QUOTE
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.
END OF QUOTE
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.