TCM
Earlier this year, I started the ‘WORST PAPER OF 2022 COMPETITION’. As a competition without a prize is no fun, I am offering the winner (that is the lead author of the winning paper) one of my books that best fits his/her subject. I am sure this will overjoy him or her.
And how do we identify the winner? I will continue blogging about nominated papers (I hope to identify about 10 in total), and towards the end of the year, I let my readers decide democratically.
In this spirit of democratic voting, let me suggest to you ENTRY No 8 (it is so impressive that I must show you the unadulterated abstract):
Introduction
Female sexual dysfunction (FSD) seriously affects the quality of life of women. However, most women do not have access to effective treatment.
Aim
This study aimed to determine the feasibility and effectiveness of the use of acupuncture in FSD treatment based on existing clear acupuncture protocol and experience-supported face-to-face therapy.
Methods
A retrospective analysis was performed on 24 patients with FSD who received acupuncture from October 2018 to February 2022. The Chinese version of the female sexual function index , subjective sensation, sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction, and dyspareunia scores were compared before and after the treatment in all 24 patients.
Main Outcome Measure
A specific female sexual function index questionnaire was used to assess changes in female sexual function before and after the acupuncture treatment.
Results
In this study, the overall treatment improvement rate of FSD was 100%. The Chinese version of the female sexual function index total score, sexual desire score, sexual arousal score, vaginal lubrication score, orgasm score, sexual satisfaction score, and dyspareunia score during intercourse were significantly different before and after the treatment (P < .05). Consequently, participants reported high levels of satisfaction with acupuncture. This study indicates that acupuncture could be a new and effective technique for treating FSD. The main advantages of this study are its design and efficacy in treating FSD. To the best of our knowledge, this is the first study to evaluate the efficacy of acupuncture in the treatment of FSD using the female sexual function index scale from 6 dimensions. The second advantage is that the method used (ie, the nonpharmacological method) is simple, readily available, highly safe with few side effects, and relatively inexpensive with high patient satisfaction. However, limitations include small sample size and lack of further detailed grouping, pre and post control study of patients, blank control group, and pre and post control study of sex hormones.
Conclusion
Acupuncture can effectively treat FSD from all dimensions with high safety, good satisfaction, and definite curative effect, and thus, it is worthy of promotion and application.
My conclusion is very different: acupuncture can effectively kill any ability for critical thinking.
I hardly need to list the flaws of this paper – they are all too obvious, e.g.:
- there is no control group; the results might therefore be due to a host of factors that are unrelated to acupuncture,
- the trial was too small to allow far-reaching conclusions,
- the study does not tell us anything about the safety of acupuncture.
The authors call their investigation a ‘pilot study’. Does that excuse the flimsiness of their effort? No! A pilot study cannot draw conclusions such as the above.
What’s the harm? you might ask; nobody will ever read such rubbish and nobody will have the bizarre idea to use acupuncture for treating FSD. I’m afraid you would be wrong to argue in this way. The paper already got picked up by THE DAILY MAIL in an article entitled “Flailing libido? Acupuncture could help boost sex drive, scientists say” which was as devoid of critical thinking as the original study. Thus we can expect that hundreds of desperate women are already getting needled and ripped off as we speak. And in any case, offensively poor science is always harmful; it undermines public trust in research (and it renders acupuncture research the laughing stock of serious scientists).
England’s record goalscorer Ellen White has revealed she suffered a punctured lung while receiving acupuncture treatment. The injury accelerated her decision to retire. White, 33, said she was still coming to terms with the “traumatic” injury.
Manchester City had sourced a “specialist” – evidently not such an excellent acupuncturist because the complication is avoidable with proper knowledge of anatomy – outside the club to provide her with acupuncture to treat her back problem because of a high number of injuries in the squad at the time. “If you’d said to me two or three years ago that you’re going to retire, I would have said ‘absolutely not’, but I’ve got to a time in my career,” she said. “I had a challenging time last year – coming back from the Olympics, I basically punctured my lung, and it was a lot for me to have to go through and a big reason that accelerated my want to retire.”
The injury happened when she returned to her club with a back spasm last summer. “It punctured my lung which isn’t something that happens normally, obviously,” she said. “It was a really traumatic time for me and something that I’m still figuring out now, still working through. I had to wait for the lung to basically inflate again. I had a needle put into my chest to drag all the air out then hopefully the lung would inflate again – which it has. At the time, I think for me, I just got into a zone of: ‘I need to get back playing. We’ve got these games – I want to be back playing for my club; I want to be back playing for England. I went very tunnel vision,” she said. “It wasn’t until a good two or three months later, it just hit me like a train, what actually happened and how traumatic it was.”
Despite her quick return to goalscoring form, which included becoming the Lionesses record goalscorer in November, the striker says she is still affected by the injury and suffers “phantom pain” where it feels like it is happening again. “It’s important for me now to tell my story, and say it was a big factor in my year and leading up to the decision of wanting to retire. Obviously, there are other factors that come into that as well. I don’t want it to happen to anybody else again is my main thing. I don’t want to walk away from the sport having not told it and not say that I want things in place for it not to happen to anyone else.”
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Pneumothorax is by far the most common of all the serious, potentially fatal complications caused by acupuncture. In thin individuals, several acupuncture points over the upper thorax are just a few centimeters away from the lung. Therefore, it is easily possible to puncture a lung by inserting an acupuncture needle. This is from my 2010 review of the subject:
About 90 deaths after acupuncture have been anecdotally documented in the medical literature. Thus, acupuncture has been associated with more deaths than most other ‘alternative’ therapies except herbal medicine … The fatalities are usually due to an acupuncture needle penetrating a vital organ. This, in turn, can cause pneumothorax, cardiac tamponade, or major haemorrhage. Most instances of this nature are reported in the Asian literature which, for most of us, is not easily accessible.
A 2013 review of ours located 1104 cases that had been reported in the Korean literature alone. However, the truth of the matter is that nobody can be sure of the exact incidence figures. Why? Because there is no monitoring system that would reliably record such incidences.
I would argue that every single case of acupuncture-induced pneumothorax tells us that the acupuncturist was not adequately trained. With proper knowledge of anatomy, such complications should not happen. Therefore, such instances are a rude reminder that so-called alternative medicine (SCAM) is far too often in the hands of “specialists” who are a danger to the public.
Should Acupuncture-Related Therapies be Considered in Prediabetes Control?
No!
If you are pre-diabetic, consult a doctor and follow his/her advice. Do NOT do what acupuncturists or other self-appointed experts tell you. Do NOT become a victim of quackery.
But the authors of a new paper disagree with my view.
So, let’s have a look at the evidence.
Their systematic review was aimed at evaluating the effects and safety of acupuncture-related therapy (AT) interventions on glycemic control for prediabetes. The Chinese researchers searched 14 databases and 5 clinical registry platforms from inception to December 2020. Randomized controlled trials involving AT interventions for managing prediabetes were included.
Of the 855 identified trials, 34 articles were included for qualitative synthesis, 31 of which were included in the final meta-analysis. Compared with usual care, sham intervention, or conventional medicine, AT treatments yielded greater reductions in the primary outcomes, including fasting plasma glucose (FPG) (standard mean difference [SMD] = -0.83; 95% confidence interval [CI], -1.06, -0.61; P < .00001), 2-hour plasma glucose (2hPG) (SMD = -0.88; 95% CI, -1.20, -0.57; P < .00001), and glycated hemoglobin (HbA1c) levels (SMD = -0.91; 95% CI, -1.31, -0.51; P < .00001), as well as a greater decline in the secondary outcome, which is the incidence of prediabetes (RR = 1.43; 95% CI, 1.26, 1.63; P < .00001).
The authors concluded that AT is a potential strategy that can contribute to better glycemic control in the management of prediabetes. Because of the substantial clinical heterogeneity, the effect estimates should be interpreted with caution. More research is required for different ethnic groups and long-term effectiveness.
But this is clearly a positive result!
Why do I not believe it?
There are several reasons:
- There is no conceivable mechanism by which AT prevents diabetes.
- The findings heavily rely on Chinese RCTs which are known to be of poor quality and often even fabricated. To trust such research would be a dangerous mistake.
- Many of the primary studies were designed such that they failed to control for non-specific effects of AT. This means that a causal link between AT and the outcome is doubtful.
- The review was published in a 3rd class journal of no impact. Its peer-review system evidently failed.
So, let’s just forget about this rubbish paper?
If only it were so easy!
Journalists always have a keen interest in exotic treatments that contradict established wisdom. Predictably, they have been reporting about the new review thus confusing or misleading the public. One journalist, for instance, stated:
Acupuncture has been used for thousands of years to treat a variety of illnesses — and now it could also help fight one of the 21st century’s biggest health challenges.
New research from Edith Cowan University has found acupuncture therapy may be a useful tool in avoiding type 2 diabetes.
The team of scientists investigated dozens of studies covering the effects of acupuncture on more than 3600 people with prediabetes. This is a condition marked by higher-than-normal blood glucose levels without being high enough to be diagnosed as diabetes.
According to the findings, acupuncture therapy significantly improved key markers, such as fasting plasma glucose, two-hour plasma glucose, and glycated hemoglobin. Additionally, acupuncture therapy resulted in a greater decline in the incidence of prediabetes.
The review can thus serve as a prime example for demonstrating how irresponsible research has the power to mislead millions. This is why I have often said that poor research is a danger to public health.
And what can be done about this more and more prevalent problem?
The answer is easy: people need to behave more responsibly; this includes:
- trialists,
- review authors,
- editors,
- peer-reviewers,
- journalists.
Yes, the answer is easy in theory – but the practice is far from it!
I have often called out unreliable or fraudulent research in the realm of Traditional Chinese Medicine (TCM). I think it is important to do so because the abundance of scientific misconduct is such that it has become a danger to public health. Today, I present yet another example:
This recent review claimed to summarize the evidence on TCM in treating MI, the clinical evaluations of TCM in treating male infertility (MI), and the molecular mechanisms of TCM effects. I was alerted to the fact that the authors cite a paper on acupuncture that I had co-authored. Here is the section in question from the review:
Acupuncture is one of the therapeutic techniques that are part of TCM. Acupuncture is a non-invasive technique and is regarded as free of risk if performed by trained personnel [35]. One of the advantages of acupuncture was that the incidence of adverse effects was substantially lower than that of many drugs or other accepted [35]. Acupuncture has been used in the treatment of male and female infertility and in assisted reproductive technology treatments for many years. A total of 100 patients with MI who met the diagnostic criteria were randomly divided into two groups [7]. Half of the patients received acupuncture treatment, and the other half received placebo acupuncture. After 10 weeks treatment, acupuncture successfully improved the indicators of the semen, including the spermatozoa survival rate, b-level activity rate, sperm density, sperm activity rate. A total of 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of acupuncture and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A-C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture [36]. Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler essence injection to acupoints and oral administration of Chinese materia medica, 142 cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective and 21 cases (7.1%) ineffective [37]. The therapeutic effect of the combination of these three treatments was satisfactory.
Ref 7
Emerging evidence has shown that cell-cell interactions between testicular cells, in particular at the Sertoli cell-cell and Sertoli-germ cell interface, are crucial to support spermatogenesis. The unique ultrastructures that support cell-cell interactions in the testis are the basal ES (ectoplasmic specialization) and the apical ES. The basal ES is found between adjacent Sertoli cells near the basement membrane that also constitute the blood-testis barrier (BTB). The apical ES is restrictively expressed at the Sertoli-spermatid contact site in the apical (adluminal) compartment of the seminiferous epithelium. These ultrastructures are present in both rodent and human testes, but the majority of studies found in the literature were done in rodent testes. As such, our discussion herein, unless otherwise specified, is focused on studies in testes of adult rats. Studies have shown that the testicular cell-cell interactions crucial to support spermatogenesis are mediated through distinctive signaling proteins and pathways, most notably involving FAK, Akt1/2 and Cdc42 GTPase. Thus, manipulation of some of these signaling proteins, such as FAK, through the use of phosphomimetic mutants for overexpression in Sertoli cell epithelium in vitro or in the testis in vivo, making FAK either constitutively active or inactive, we can modify the outcome of spermatogenesis. For instance, using the toxicant-induced Sertoli cell or testis injury in rats as study models, we can either block or rescue toxicant-induced infertility through overexpression of p-FAK-Y397 or p-FAK-Y407 (and their mutants), including the use of specific activator(s) of the involved signaling proteins against pAkt1/2. These findings thus illustrate that a potential therapeutic approach can be developed to manage toxicant-induced male reproductive dysfunction. In this review, we critically evaluate these recent findings, highlighting the direction for future investigations by bringing the laboratory-based research through a translation path to clinical investigations.
This paper does not relate to the statement it is meant to support by the review authors.
Ref 35
The review by Qin et al (1) includes 5 trials none of which should have been included in a quality metaanalysis as the methodology was unconvincing: In the trial by Alraek et al., patients were randomised to receive either acupuncture or no treatment. This means that no attempt was made to control for the effects of placebo or extra attention. Therefore, this study does not demonstrate an effect of acupuncture as the outcome could be due to non-specific effects unrelated with this therapy. By contrast, the trial by Aune et al. did attempt to control for placebo effects by using a sham control group. Sham acupuncture was given using six needles superficially inserted in the calves, thighs or abdomen outside known acupuncture points or meridians. Needles were not manipulated in the sham group. Sham or placebo controls have the purpose of rendering patients unaware of whether they receive the real or the sham treatment. The method used here cannot achieve this aim; patients would be easily able to tell which intervention they received. In other words, this study also did not adequately control for placebo effects. The remaining three trials are all not Medline-listed, authored by Chinese investigators and published in inaccessible journals. This should disqualify them from inclusion as they were unverifiable by the peer review process. According to the published table, they were equivalence trials of acupuncture versus antibiotics with a sample size around 30. This means they are grossly underpowered and thus unable to generate reliable results. Unless BJOG peer reviewers could see the primary articles, or be provided with translations from Chinese, the systematic review should not have been accepted. The “many eyes of science” requires transparency, testing, challenge and verification. Although in the past, inconclusive results of acupuncture have not been thought to be due to Chinese influence (2), it has been noted that virtually all recent published acupuncture trials are “positive” (3), raising questions of publication and other biases. Our colleagues are under tremendous pressure to publish, but we do them no favours by effectively lowering the standard of scientific peer review. Elite journals too have an obligation to train and reiterate about publication ethics and sound scientific writing (4). As none of the primary studies convincingly demonstrated that acupuncture is an effective therapy for recurrent urinary tract infections, no positive conclusion was warranted. Although Qin et al. did state that the risk of bias of the included trials was generally high or unclear (1), the BJOG nevertheless allowed them to turn massive uncertainty into relatively firm, positive conclusions in the abstract (“Acupuncture appeared to be beneficial for treatment and prophylaxis of rUTIs”) and tweetable abstract (“This review found that acupuncture may improve treatment and prevent recurrence of urinary tract infection in women”), thus leading to excited media headlines that inevitably mislead the public. ‘May’ is a weasel word which should be avoided as it is unfalsifiable (for example, pigs do not fly but they ‘may’ fly in the future). The definite, straightforward conclusion must be “There is no good evidence to support the use of acupuncture for the treatment and prophylaxis of recurrent UTIs”. It is not acceptable to give international credibility to an implausible modality that no objective, independent high-quality review has found effective beyond placebo (5). The dampening accompanying mini-commentary (6) does not undo the damage.
The review should be withdrawn while the primary papers are translated for peer reviewers to examine, the above limitations discussed in the text, and the positive ‘spin’ in conclusions corrected. These improvements would consolidate the researchers’ probity and justify the accolade of BJOG publication.
Our letter to the editor does not bear any relation to the statement it is meant to support by the review authors.
Ref 36
In this first prospective, randomized, single-blind, placebo-controlled study, 28 infertile patients with severe oligoasthenozoospermia received acupuncture according to the principles of traditional Chinese medicine (TCM) and 29 infertile patients received placebo acupuncture. A significantly higher percentage of motile sperm (World Health Organization categories A–C), but no effect on sperm concentration, was found after acupuncture compared with placebo acupuncture.
This small study is far from convincing and does not lend itself to far-reaching conclusions
Ref 37
Of the 279 cases of male sterility treated by the combination of acupuncture, pilose antler
essence injection to acupoints and oral administration of Chinese materia medica, 142
cases (47.8%) were cured, 81 cases (27.3%) markedly effective, 53 cases (17.8%) effective
and 21 cases (7.1%) ineffective. The therapeutic effect of the combination of these three
treatments was satisfactory.
This study had no control group and used two different therapies. Therefore, it does not allow any conclusion about the effectiveness of acupuncture.
____________________
Perhaps you feel that these errors are trivial. But I would disagree. The review authors’ praise of acupuncture for MI is misplaced and will mislead the public. There are plenty of reviews on the subject, and those that are not overtly biased arrive at conclusions like these:
- The current evidence on acupuncture for oligoasthenozoospermia is inadequate to draw a solid conclusion due to the poor methodological quality. Rigorous full-scale RCTs are needed to validate the therapeutic efficacy and safety of acupuncture in treating oligoasthenozoospermia.
- The current evidence showing that acupuncture might improve poor semen quality is insufficient because of the small number of studies, inadequacy of procedures and/or insufficient information for semen analysis, high levels of heterogeneity, high risk of bias, and poor quality of reporting. Further large, well-designed RCTs are required.
So, how did this sloppy review come about?
Its authors are affiliated to the TCM Regulating Metabolic Diseases Key Laboratory of Sichuan Province, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China, and the Tea Research Institute, Sichuan Academy of Agricultural Sciences, Chengdu 610066, China. A footnote tells us that their review was supported by the National Natural Science Foundation of China [No. 81973647] and the Xinglin scholar discipline promotion talent program of Chengdu University of traditional Chinese medicine [No. BSH2021018]. This sounds respectable enough.
The journal that published the review is ‘Pharmacological Research – Modern Chinese Medicine‘. Its stated aims are as follows: The journal publishes articles reporting on advances in our comprehension of mechanism and safety in experimental pharmacology and clinical efficacy and safety of pharmacologically active substances, including compound prescriptions, utilized in Traditional Chinese Medicine applying modern scientific research methods. Studies reporting also on the mechanisms of actions of the active substance(s) investigated are encouraged.
The editors in chief of the journal are Guan-Hua Du, PhD, China Academy of Chinese Medical Sciences Institute of Chinese Materia Medica, Beijing, China and Emilio Clementi, M.Mus, MD, PhD, University of Milan, Milan, Italy. No doubt, these are respectable scientists. And because they are, they should make sure that what they publish is correct – a criterion this recent review clearly does not meet.
The US Food and Drug Administration (FDA) state that dietary supplements can help people improve or maintain their overall health. But they may also come with health risks. Whether you’re a consumer of dietary supplements or it’s your job to inform and educate, it’s important to know the facts before deciding to take any dietary supplement.
Therefore, they launched the initiative, “Supplement Your Knowledge”. It aims to help inform health care professionals, consumers, and educators about dietary supplements.
“Dietary supplements can be valuable to your health but taking some supplements can also involve health risks,” Douglas Stearn, JD, deputy director for regulatory affairs in the FDA’s Center for Food Safety and Applied Nutrition, said in a statement. “These Supplement Your Knowledge resources will help provide consumers and health care professionals with facts to make informed decisions when determining if they want to use or recommend dietary supplements.”
In collaboration with the American Medical Association, publisher of JAMA, the FDA has developed a free continuing medical education program for physicians and other health care professionals about the regulation of dietary supplements, informing patients about their use, and reporting adverse events to the agency. The program includes 3 videos and accompanying educational materials. It is available on the FDA website and the AMA Ed Hub.
________________________
The objectives of the program are:
1. Define dietary supplements
2. Describe how dietary supplements are regulated
3. Describe how dietary supplements are labelled and the types of claims permitted
4. Review potential interactions of dietary supplements with other supplements, medications, and laboratory tests
5. Identify adverse events and how to report them to FDA
Even though some parts of the program are quite specific to the US, I think that the initiative is most laudable and an excellent resource for physicians, SCAM practitioners, consumers, and decision-makers to learn more about this important subject.
The US Food and Drug Administration created the Tainted Dietary Supplement Database in 2007 to identify dietary supplements adulterated with active pharmaceutical ingredients (APIs). This article compared API adulterations in dietary supplements from the 10-year time period of 2007 through 2016 to the most recent 5-year period of 2017 through 2021. Its findings are alarming:
- From 2007 through 2021, 1068 unique products were found to be adulterated with APIs.
- Sexual enhancement and weight-loss dietary supplements are the most common products adulterated with APIs.
- Phosphodiesterase-5 inhibitors are commonly included in sexual enhancement dietary supplements.
- A single product can include up to 5 APIs.
- Sibutramine, a drug removed from the market due to cardiovascular adverse events, is the most included adulterant API in weight loss products.
- Sibutramine analogues, phenolphthalein (which was removed from the US market because of cancer risk), and fluoxetine were also included.
- Muscle-building dietary supplements were commonly adulterated before 2016, but since 2017 no additional adulterated products have been identified.
The authors concluded that the lack of disclosure of APIs in dietary supplements, circumventing the normal procedure with clinician oversight of prescription drug use, and the use of APIs that are banned by the Food and Drug Administration or used in combinations that were never studied are important health risks for consumers.
The problem of adulterated supplements is by no means new. A similar review published 4 years ago already warned that “active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”
These papers relate to the US where supplement use is highly prevalent. The harm done by adulterated products is thus huge. If we focus on Chinese or Ayurvedic supplements, the problem might even be more serious. In 2002, my own review concluded that adulteration of Chinese herbal medicines with synthetic drugs is a potentially serious problem which needs to be addressed by adequate regulatory measures. Twenty years later, we seem to be still waiting for effective regulations that protect the consumer.
Progress in medicine, they say, is made funeral by funeral!
Ischemic heart disease (IHD) related to cardiovascular or cerebrovascular disease is the leading cause of mortality and an important issue of public health worldwide. The cost of long-term healthcare for IHD patients may result in a huge financial burden. This study analyzed the medical expenditure incurred for and survival of IHD patients treated with Chinese herbal medicine (CHM) and Western medicine.
Subjects were randomly selected from the National Health Insurance Research Database in Taiwan. The Cox proportional hazards regression model, Kaplan–Meier estimator, logrank test, chi-square test, and analysis of variance were applied. Landmark analysis was used to assess the cumulative incidence of death in IHD patients.
A total of 11,527 users were identified as CHM combined with Western medicine and 11,527 non-CHM users. CHM users incurred a higher medical expenditure for outpatient care within 1 (24,529 NTD versus 18,464 NTD, value <0.0001) and 5 years (95,345 NTD versus 60,367 NTD, value <0.0001). However, CHM users had shorter hospitalizations and lower inpatient medical expenditure (7 days/43,394 NTD in 1 year; 11 days/83,141 NTD in 5 years) than non-CHM users (11 days/72,939 NTD in 1 year; 14 days/107,436 NTD in 5 years).
The CHM group’s adjusted hazard ratio for mortality was 0.41 lower than that of the non-CHM group by Cox proportional hazard models with time-dependent exposure covariates. Danshen, Huang qi, Niu xi, Da huang, and Fu zi were the most commonly prescribed Chinese single herbs; Zhi-Gan-Cao-Tang, Xue-Fu-Zhu-Yu-Tang, Tian-Wang-Bu-Xin-Dan, Sheng-Mai-San, and Yang-Xin-Tang were the five most frequently prescribed herbal formulas in Taiwan.
The authors concluded that combining Chinese and Western medicine can reduce hospital expenditure and improve survival for IHD patients.
Why, you will ask, do I think that this study deserves to be in the ‘worst paper cometition’?
It is not so bad!
It is an epidemiological case-control study with a large sample size that generates interesting findings.
Agreed!
But, as a case-control study, it cannot establish a causal link between CHM and the outcomes. You might argue that the conclusions avoid doing this – “can … improve survival” is not the same as “does improve survival”. This may be true, yet the title of the article leaves little doubt about the interpretation of the authors:
Chinese Herbal Medicine as an Adjunctive Therapy Improves the Survival Rate of Patients with Ischemic Heart Disease: A Nationwide Population-Based Cohort Study
I find it difficult not to view this as a deliberate attempt of the authors, editors, and reviewers to mislead the public.
Looking at the details of the study, it is easy to see that the two groups were different in a whole range of parameters that were measured. More importantly, they most likely differ in a range of variables that were not measured and had significant influence on IHD survival. It stands to reason, for instance, that patients who elected to use CHM in addition to their standard care were more health conscious. They would thus have followed a healthier diet and lifestyle. It would be foolish to claim that such factors do not influence IHD survival.
The fact that the authors fail even to mention this possibility, interpret an association as a causal link, and thus try to mislead us all makes this paper, in my view, a strong contender for my
WORST PAPER OF 2022 COMPETITION
Due to polypharmacy combined with the rising popularity of so-called alternative medicines (SCAM), oncology patients are at particular risk of drug-drug interactions (DDI) or herb-drug interactions (HDI). Caution is therefore indicated.
The aims of this study were to assess DDI and HDI in outpatients taking oral anticancer drugs.
All prescribed and non-prescribed medications, including SCAM, were prospectively collected by hospital pharmacists during a structured interview with the patient. DDI and HDI were analyzed using four interaction software programs: Thériaque®, Drugs.com®, Hédrine, and Memorial Sloan Kettering Cancer Center (MSKCC) database. All detected interactions were characterized by severity, risk, and action mechanism. The need for pharmaceutical intervention to modify drug use was determined on a case-by-case basis.
294 patients were included, with a mean age of 67 years. The median number of chronic drugs per patient was 8 [1-29] and 55% of patients used at least one SCAM. At least 0ne interaction was found for 267 patients (90.8%): 263 (89.4%) with DDI, 68 (23.1%) with HDI, and 64 (21.7%) with both DDI and HDI. Only 13% of the DDI were found in Thériaque® and Drugs.com® databases, and 125 (2.5%) were reported with a similar level of risk on both databases. 104 HDI were identified with only 9.5% of the interactions found in both databases. 103 pharmaceutical interventions were performed, involving 61 patients (20.7%).
The authors concluded that potentially clinically relevant drug interactions were frequently identified in this study, showing that several databases and structured screening are required to detect more interactions and optimize medication safety.
This figure of potential HDIs is high – much higher than in most previous studies. A possible explanation could be that the study was carried out in France where the use of herbal remedies is considerable. As some HDIs can cause serious problems for patients, my advice is to think twice about using herbal remedies while taking prescription drugs. I think this advice is sound regardless of whether someone is suffering from cancer or any other condition.
Guest post by Ken McLeod
Believe it or not, there are practitioners of a health system with little or no evidence of efficacy and safety who are registered with the Australian Health Practitioner Registration Agency. That is, so-called Traditional Chinese Medicine, whose practitioners are registered alongside evidence-based practitioners such as doctors, nurses, pharmacists, and dentists.
Governments who framed the relevant legislation evidently hoped that registration would enable the public to have confidence that they would be treated with evidence-based medicine. Such confidence is misplaced, as has been shown in The Skeptic and elsewhere many times.
Here’s another example of the failure of the health practitioner registration system.
Jamie Lloyd Allan is registered with AHPRA with the Chinese Medical Registration Number CMR0002096457, with no endorsements. He practices at his clinic in eastern Sydney. He advertises at his website meridianremedies.com.au.
And some of his claims are deeply worrying. Allan claims that he uses “Chinese Herbal medicine & Acupuncture in conjunction with testing and removal of accumulated toxins and heavy metals, developing comprehensive individualised herbal antimicrobial and detoxification protocols.”
He claims that “toxins and heavy metals … enter our bodies, disrupt normal healthy cell behaviour, impair our immune system, often contribute and sometimes cause many different types of illnesses and health conditions.”
His claims are designed to generate unfounded worries in people, offering a smorgasbord of claims how he can help people learn [the words and spelling are his]:
• how mercury from common amalgam fillings can be passed from mother to child to grandchild and why preconception detoxification is important;
• how to assess a dentist to know your [sic] getting the best and safest care during amalgam removal;
• about mercury/autism connection, heavy metal accumulation and neurological diseases such as Alzheimer’s, Parkinson’s and Dementia;
• more about mercury, aluminium, cadmium and lead toxicity;
• how heavy metal accumulation acts as an antenna for electromagnetic radiation from devices such as wifi, cell phone, cordless phones, thus focusing the frequencies on the areas where the metals are stored, causing changes in the proteins and even DNA;
• the science behind electromagnetic radiation and how it affects human cells;
• Glyphosate toxicity, and how many of us have it and how it affects our health, and lots more.
Allan goes into the alleged toxicity of mercury amalgam fillings further at his blog. I should not have to say it, but his claims are baseless and have been debunked many times. The US Food and Drug Administration has said that existing evidence shows that dental amalgam is not harmful to the general population (tinyurl.com/589mbrr6). And as Scientific American said “Mercury and Autism: Enough Already! The science shows that they have nothing to do with each other and never have.” (tinyurl.com/mwwdxxak)
Allan also writes extensively on “EMF Sensitivity Wi-Fi and Cell Phone radiation – Heavy Metals and EMF Sensitivity and Autism” – he claims “Autism rates double every 5 years and the only thing that parallels that in our environment is the increase of man made Electro magnetic Radiation and fields largely in the high frequencies from cell phone Wi-Fi, smart meters and other Electro magnetic devices.’ This is unconscionable; scaring potential clients with this, while conveniently forgetting that correlation does not mean causation.
Allan also offers the following techniques as a “Detox for autism”:
• Sauna or heat therapy (far infrared is best) Cold shower straight after to close pores and wash of toxins
• Clay plasters, Clay on scars, then shower
• Ionic Foot Cleanses, Detox baths, Takara foot Pads, or raw white potato strapped on soles of feet
• Fibre + Enemas or colonics, slippery elm, keep bowls [sic] moving
• Liver gall bladder flush with lemon oil
• Exercise, dry skin brush
• Chi Machine for lymph drainage and movement to parasympathetic dominance
• Olive or other healthy oils for swish and spit
• Genetic, vitamin, mineral testing to guide your diet and supplements
• Western and Chinese Herbs to detox bowls [sic], liver, kidney, lymph
• Homeopathic drops & plenty of water orally
• Laser Energetic detox
• Ozonized bath, Epson salt bath
• Enema for detox reactions in kids
• Stronger detox agents DMPS, DMSA, EDTA can be used in case of high-level toxicity. For children, the use of the above mention techniques over DMPS, DMSA and EDTA is preferred first.
“Raw white potato strapped on soles of feet”!! Come on! This is lunacy. And enemas for children? And what qualifications does Allan hold to diagnose and administer these dangerous pharmaceuticals?
Luckily, Allan offers the perfect scanner to diagnose what’s wrong with you, the Oligoscan.
As described, “This a [sic] spectrographic-based test. Every element on the periodic table has its own unique absorption spectra, meaning that different elements absorb certain wavelengths of light, and reflect others. The spectra of lead will be different from that of mercury, or calcium, or any other element. The Oligoscan shines a laser on different points on the hand, and based off of [sic] which wavelengths of light are absorbed or reflected back, the levels of different metals and minerals in the cells of your hand can be determined. This is similar to how astronomers can analyze the wavelengths of light emitted by distant stars to determine their chemical make-up.
“The Oligoscan has the advantage of testing the levels of metals that are actually in your cells, not what you are able to excrete. It tests the heavy metal load of the tissues. This is important because heavy metals have a affinity [sic] for tissues and are often store [sic] there and not in the blood. It can also measure aluminium, which most other tests will miss. Oligoscan results tend to correlate with other accurate tests.”
A search of the TGA’s register of therapeutic goods did not find the Oligoscan listed.
Clearly, Allan is engaged in a process of scaring potential clients with misinformation, then offering diagnostic and treatment processes that are deceptive, ineffective and dangerous, and not listed with the TGA; for all of which he is not qualified.
COMPLAINT PROCESS
A complaint was sent to the NSW Health Care Complaints Commission describing the above issues. (In NSW and Queensland, complaints concerning health care practitioners, registered and unregistered, are lodged with the relevant State authorities, the HCCC and OHO respectively.) We added that “This should not be treated as merely a case of misleading advertising; Allan is clearly endangering the public, so I recommend a thorough audit of his practice, and when my allegations are found to be proven, suitable disciplinary action taken and entered on the AHPRA register.”
The HCCC responded saying “Following consultation with the Chinese Medicine Council of New South Wales, it was decided to refer this matter to the Australian Health Practitioner
Regulation Agency (AHPRA) as AHPRA is the designated agency to manage concerns about advertising. We did not identify any other issues that would require further action by the Commission.” (We approached the Chinese Medicine Council of NSW – their response is quoted in the sidebar.)
The HCCC continued: “The Commission obtained a written response from Mr Allan. In his response to the Commission, Mr Allan stated that he had no record of providing any care and treatment to you.
“Mr Allan acknowledged that his website may have created a misunderstanding about what actual treatments are offered at his clinic, and what was on his website for educational purposes only.
“Mr Allan noted that he has never owned an Oligoscan or used it at his clinic, he has therefore removed that information from his website.
“Mr Allan confirmed that he does not offer the techniques under the heading ‘detox for autism’ at his clinic, the information was for educational purposes only, and he has now removed this information from his website.
“Further, Mr Allan has confirmed that he has removed the information on his website about Glyphosate Toxicity, Toxicity of Mercury Amalgam fillings, Nutrition for Autism, and all avenues of receiving mercury toxicity.
“Mr Allan also stated that he has since edited the information on EMF Sensitivity Wi-Fi and Cell Phone radiation – Heavy Metals and EMF Sensitivity Autism, as well as editing the information contained on the home and about pages of his website.
“Mr Allan stated that he has left the resources section with all the raw studies, and some information contained in other sections, as he feels that they are of use for anybody wanting to learn more about this specialised area.”
So, in spite of the detailed evidence and a call for a thorough audit of his practice, this was treated as merely a case of misleading advertising. This is standard operating procedure; the regulatory authorities cannot get over the divide between advertising and clinical practice. This has been shown in the hundreds of complaints sent to regulators; misleading advertising of dangerous practices and misinformation is simply treated as an advertising issue. The regulators cannot accept that if a practitioner advertises a therapy then they are more than likely using those therapies and, when those therapies have been found to be ineffective, they are engaging in practice in their clinics that deserves more than the dismissive response we received.
The public deserve much better than that.
Note: All of the quotes above were from Allan’s website until he removed them. The relevant pages have, nonetheless, can be accessed via the WayBack Machine, and can be supplied if required.
The Chinese Medicine Council’s position
The Chinese Medical Council were referred to the issues in the main article and were asked the following questions:
• Is the advice and those therapies [offered by Allan] of any concern to the Council?
• Should the complaint to the NSW Health Care Complaints Commission have led to an audit of his practice and when the allegations are proven, should there have been disciplinary action?
A spokesperson for the Chinese Medicine Council of NSW replied: “The Chinese Medicine Council of NSW (the Council) works in collaboration with the NSW Health Care Complaints Commission (HCCC) to receive and manage complaints about registered practitioners in
NSW. Our paramount legal obligation is to protect the public. We deal with practitioners whose conduct, performance or health may represent a risk to the public or is not in the public interest.
“We do this by assessing complaints, promoting compliance with professional standards and delivering programs to ensure practitioners provide safe care to the public and their patients. We do not have the legal power to discipline a NSW practitioner or to deregister them.
“By law, the Council cannot provide information about an individual practitioner. Only information that is publicly available can be disclosed, such as information recorded on the national register of practitioners which is maintained by the Australian Health Practitioner Regulation Agency (AHPRA), or publication of the outcomes of NCAT [New South Wales Civil and Administrative Tribunal] proceedings.
“Changes to a registered health practitioner’s registration status, such as the imposition of conditions or suspension, are published on the AHPRA online public register.
“The Council will not be making any further public comments at this time.
So, the Chinese Medicine Council have taken no action to protect the public and made no real comment. At least they have promised “Only information that is publicly available can be disclosed”, a statement of breathless inanity.
*‘first published in the Australian Skeptic magazine of June 2022.
Guest post by Derk P. Kooi
Political lobbying is not only restricted to major companies, even quackery lobbies extensively in Dutch politics as well as at a European and global level. The EUROpean Complementary and Alternative Medicine Stakeholder Group (EUROCAM) has been active in Europe for some time. EUROCAM recently attracted attention with a statement on antibiotic resistance during the European Antibiotics Awareness Day.[1] EUROCAM claims that Complementary and Alternative Medicine (CAM) could enhance the immune system and could therefore contribute to the fight against antibiotic resistance. An early study conducted by the anthroposophist Erik Baars was referenced, inter alia. However, this medical claim turns out to be pure nonsense.
EUROCAM regularly publishes so-called ‘position papers’ on the contribution CAM could provide to the European health care system. EUROCAM is currently cautious with its medical claims, and rightly so, as it has seriously overstepped the mark in the past. For example, claims about the efficacy of CAM for infections referred to research by Erik Baars, doctor, anthroposophical healthcare lector at the University of Applied Sciences Leiden and researcher at the Louis Bolk Institute. Baars is an associate of the society due to his misleading statements in his publications on the usefulness of CAM, more specifically of the anthroposophical variant.
Where does this fairly unknown club actually come from, what does it do and how seriously should we take it? Well, EUROCAM is an umbrella organisation for various alternative therapists and their patients. We are talking about Ayurveda, homeopathy, osteopathy, anthroposophy, herbal medicine, traditional (Chinese) medicine, Reiki and acupuncture. The Dutch Registry of Complementary Care Professionals (RBCZ) is also affiliated with EUROCAM. Classical homeopath Annemieke Boelsma is the contact person of the RBCZ at EUROCAM.
It is unclear precisely when EUROCAM was created, the LinkedIn page says 2009. The figurehead of the club is “secretary general” Ton Nicolaï. This homeopathic doctor is also well known to Vereniging tegen de Kwakzalverij, (www.kwakzalverij.nl) the Dutch Society against Quackery. The treasurer of EUROCAM is business administrator Wim Menkveld. Menkveld is on the Advisory Board of the Hortus Botanicus of Leiden. He is also active on the board of the European Patients’ Federation of Homeopathy. EUROCAM thus seems to have originated mainly from Dutch homeopathic circles.
Furthermore, TV producer Miranda Eilert-Ruchtie from Hilversum sits on the EUROCAM board. According to the EUROCAM website, she acts as their “operations manager” and communications advisor. The German Heilprakterin Sonja Maric, an anthropologist and “specialist in Tibetan medicine”, also acts as a communications consultant.
The European Transparency Register shows that in 2020 the total budget of the organisation was 40,498 euros; no more recent data is available. In the year 2018, 5,000 euros were reserved as an honorarium for Mr Nicolaï, for the 0.5 FTE that he works for the organisation. Miranda Eilert-Ruchtie works a number of hours a week for EUROCAM, as a freelancer. Sonja Maric does this on a voluntary basis.
EUROCAM is a member of the European Public Health Alliance (EPHA), the European Union Health Policy Platform. The World Health Organisation (WHO) recognises the organisation as a non-state actor, which means that both the EU and the WHO consider EUROCAM to be a serious legal entity. In the past, EUROCAM has intervened in public EU consultations in the fields of aging, pharmaceutical strategy, cancer, and digital data and services.
EUROCAM provides the secretariat of the MEP Interest Group on Integrative Medicine and Health, a group of five European parliamentarians who have set themselves the goal of promoting integrative medicine at the European level. Co-chairs are Finish Sirpa Pietikäinen, a European parliamentarian for the Christian Democrats, and French Michèle Rivasi, a European parliamentarian for the Greens. The other members are Luxembourg’s Tilly Metz, the Italian Eleonara Evi, and the Danish Margrete Auken. It is noteworthy that they are European parliamentarians for the Greens. They are all members of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). Eleonara Evi was part of the illustrious Five Star Movement until 2020, known for its anti-vaccination stance. The Member of European Parliament (MEP) Interest Group organises annual events with speakers who are the same people who perform at EUROCAM symposia. These include the aforementioned anthroposophist Erik Baars. Baars worked closely with EUROCAM boss Ton Nicolaï in a European research project on CAM alternatives to antibiotics. More about his bad science later.
The texts EUROCAM produces nowadays (on its website) are carefully written, and the medical claims are carefully formulated. The texts are larded with synonyms for “possible”, known in linguistics as hedging. For example “Several CAM methods have shown high potential to reduce cancer pain”.[2] Generic health claims are also often used to suggest medical benefits, for example in the context of COVID-19, ‘In building and maintaining resistance to infectious illness, CAM modalities as a part of Integrative Medicine & Health can play an important role because they mobilise and stimulate people’s self-regulating capacity, thus increasing their resilience, their immune system.’.[3]
Furthermore, claims are put in the mouths of others, which can be read, for example, in quoting patient expectations: ‘While improving quality of life is the major rationale for CAM use, there is a definite undercurrent of expectation, particularly among the younger patients, that some therapies might have an anticancer effect (prolongation of remission periods) and slow/stagnate tumour growth (prolongation of survival periods), boost the immune system, making it easier to overcome the disease.’.[4]
The educated reader will immediately see through these strategies, but the question is whether the lobbied politicians targeted by EUROCAM understand these subtleties. EUROCAM has not always been so cautious, by the way. In an undated (presumably 2013) interview with the Dutch Association for Classical Homeopathy, “secretary general” Ton Nicolaï made a number of remarkable statements. For example, he claimed at the time that research shows “that for a number of herbal medicines there is a reasonable amount of evidence that scientifically confirms their effectiveness in respiratory infection treatments”. [5] Nicolaï bases his assertion on recent research by Erik Baars conducted as part of a European research programme that aimed to find CAM alternatives to antibiotics.
The report of this project, which ended in 2018, can be found on the EUROCAM website.[6] The authors of this report are, not surprisingly, Erik Baars and Ton Nicolaï. The report contains practically no hard science. Sub-studies focus on, for example, the frequency of antibiotic prescribing among alternative-working GPs and on the best practice of CAM believers. A so-called systematic review of systematic reviews offers good starting points to evaluate Mr Nicolaï’s claim: ‘A systematic review of systematic reviews demonstrates that there are specific, evidence-supported, promising CAM treatments for acute, uncomplicated RTIs [uncomplicated respiratory tract infections, ed.] and that they are safe.’
Here, a medical claim is made, which is weakened by the use of the hedge term “promising”. The conclusion can be summarised with “There would be ‘promising’ CAM treatments for respiratory infections, and they would be safe”. However, surprisingly, the project report does not refer to this “systematic review of systematic reviews”, nor to any of the other concrete results of the project!
Due to the lack of references, we cannot but conclude that the claim is based on a 2019 article by Erik Baars. One of the co-authors is Ton Nicolaï.[7] The article was published in the journal Evidence Based Complementary and Alternative Medicine (EBCAM), which has a shady reputation. Even one of the founders of EBCAM states that the peer-review system is a farce, and therefore the majority of the articles published in it are useless nonsense.[8] In this article, besides a large amount of vagueness about the “worldview differences” between CAM and medicine, systematic reviews are discussed about the effectiveness and safety of CAM treatments. From this systematic review of systematic reviews, it is concluded that there are promising CAM treatments for respiratory, urinary tract and skin infections and that there is even evidence that some CAM treatments are effective for respiratory infections, but what is this based on?
The reviews that were looked at were split into Cochrane and non-Cochrane reviews. Among the Cochrane reviews, there is one that would demonstrate the efficacy of CAM. It is a review on the use of immunostimulants for the prevention of respiratory tract infections in children.[9] Of the 35 studies that were analysed, six involve small molecules, such as isoprinosine, levamisole and pidotimod. In other words, regular medicine, if it turns out to work, but describing it as being experimental would be more appropriate. Baars’ article states that the review also contains herbal medicine. This is somewhat exaggerated: only one of the 35 studies deals with herbs. Of the remaining 28 studies, 25 cover bacterial extracts and three thymus extracts. Again: Baars does not make clear what this has to do with the CAM that EUROCAM represents.
In summary, EUROCAM is a small European lobbying organisation with perhaps some influence at both European and WHO level. One keeps coming across the same names. The organisation is currently using woolly, disguising language to mask medical claims and to fend off criticism. In the past, this was different when EUROCAM, by means of Ton Nicolaï among others, made very reprehensible statements about the role of CAM in (respiratory tract) infections. For the time being, this little club does not seem to pose much of a threat, but European politicians should, of course, ignore this hobby club.
References
1. ‘Improving patient resilience to reduce the need to rely on anti-infection treatment: the role of Integrative Medicine’. EUROCAM. https://cam-europe.eu/statement-on-amr-2021/ (visited on 28 December 2021) 2. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 3. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 4. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021)
5. Miranda Ruchtie. In gesprek met Ton Nicolaï, CAM integreren in de Europese gezondheidszorg. [In discussion with Ton Nicolaï, integrating CAM into the European health care system]. Nederlandse Vereniging van Klassiek Homeopaten. [Dutch Association of Classical Homeopaths] https://www.nvkh.nl/nieuwsbrieven-nvkh/interview-met-ton-nicolai (visited on 3 October 2021)
6. Erik Baars, et al. Reducing the need for antibiotics, the contribution of Complementary and Alternative Medicine. EUROCAM, 2018. https://cam-europe.eu/wp-content/uploads/2019/01/CAM-AMR-EUROCAM-Post-Conference-Paper-2018.pdf (visited on 3 October 2021)
7. Erik W. Baars et al. The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies. Evid. Based Complement. Alternat. Med., 2019:5365608. DOI: 10.1155/2019/5365608
8. Edzard Ernst. “EBCAM: an alt med journal that puzzles me a great deal”, URL: http://edzardernst.com/2016/05/ebcam-an-alt-med-journal-that-puzzles-me-a-great-deal/ (visited on 8 January 2022)
9. B. E. Del-Rio-Navarro, F. J. Espinosa-Rosales, V. Flenady, and J. J. Sienra-Monge, “Cochrane Review: Immunostimulants for preventing respiratory tract infection in children,” Evidence-Based Child Health: A Cochrane Review Journal, 2012, 7 (2), 629–717.
