MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

risk

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During their cancer treatment path, cancer patients use numerous drugs,e.g.:

  • anticancer medications,
  • supportive drugs,
  • other prescribed medications,
  • herbal remedies,
  • other OTC products.

This puts them at risk of significant drug interactions (DIs).

This study describes potential DIs in cancer patients and their prevalence and predictors.

A cross-sectional study was carried out in two centers in the northern West Bank, Palestine. The Lexicomp® Drug Interactions tool (Lexi-Comp, Hudson OH, USA) was applied to check the potential DIs. In addition, the Statistical Package for the Social Sciences (SPSS) was used to show the results and find the associations.

The final analysis included 327 patients. Most of the participants were older than 50 years (61.2%), female (68.5%), and had a solid tumor (74.6%). The total number of potential DIs was 1753, including 1510 drug-drug interactions (DDIs), 24 drug-herb interactions, and 219 drug-food interactions. Importantly, the prevalence of DDIs was 88.1%. In multivariate analysis, the number of potential DDIs significantly decreased with the duration of treatment (p = 0.007), while it increased with the number of comorbidities (p < 0.001) and the number of drugs used (p < 0.001).

The authors concluded that they found a high prevalence of DIs among cancer patients. This required health care providers to develop a comprehensive protocol to monitor and evaluate DIs by improving doctor-pharmacist communication and supporting the role of clinical pharmacists.

What the investigators did not study was the possibility of herb-herb and herb-non-herbal supplement interactions. The reason for this is probably simple: we know too little about these areas to make reasonable judgments. But even in the absence of such considerations, the prevalence of DDIs among cancer patients was high (88.1%). This means that the vast majority of cancer patients had at least one potential DDI. Over half of them were classified as moderately severe or worse.

The lessons seem to be to:

  • use only truly necessary drugs and omit all remedies that are of doubtful value,
  • educate the public about the risks of interactions,
  • be skeptical about the messages of integrative medicine,
  • consult a healthcare professional who is competent to make such judgments,
  • conduct more rigorous research to increase our knowledge in this complex area.

I have previously reported about the ‘Havelhöhe Community Hospital’ in Berlin and its medical director, Prof Harald Matthes. He made headlines two years ago when he claimed that anthroposophical remedies were effective for treating COVID. More recently, Matthes made headlines again when he went on TV claiming that serious adverse effects of COVID vaccinations were 40 times more frequent than generally accepted.

Now a German newspaper reports more about the ‘Havelhöhe Community Hospital’ and its medical director. Here are a few (translated) passages from this remarkable article:

At the Havelhöhe Community Hospital in Berlin, there are considerable shortcomings in the handling of the Corona pandemic … basic protective measures are in part neither adhered to nor monitored. In addition, employees of the anthroposophical clinic are recommended a vaccination regimen for which there is no approval, i.e. the option of “dose splitting with frequency increase,” in which the vaccine usually administered at one time is to be divided among several injections.

However, there is no official basis for this vaccination scheme. “There is no vaccine approved for it, and it does not correspond in any way to the Stiko recommendation,” said Gudrun Widders, the public health officer responsible. “My hair stands on end when I hear that,” says the head of the Berlin-Spandau health department, who is also a member of the Standing Commission on Vaccination.

Visitors of the hospital Havelhöhe can enter buildings and wards without control of the inoculation status or a daily updated test result which is against current regulations in Germany. While other Berlin hospitals such as the Charité imposed bans on visitors, a public concert took place at Havelhöhe Hospital, where the audience did not wear a mask, contrary to the valid Corona protection regulation. Employees of the hospital also report to the taz that many of the hospital staff are lax about wearing masks, even when on duty.

“I can only say something when I see someone,” said hospital director Harald Matthes. “And I don’t see anyone with me in the hospital who walks around without a mask.” Matthes had publicly criticized corona measures as excessive on several occasions.

________________________________

I have said it before and I say it again: in my view, Matthes’ behavior amounts to serious professional misconduct. I, therefore, suggest that his professional body, the Aerztekammer, look into it with a view of preventing further harm.

 

 

 

Ayush-64 is an Ayurvedic formulation, developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), the apex body for research in Ayurveda under the Ministry of Ayush. Originally developed in 1980 for the management of Malaria, this drug has now been repurposed for COVID-19 as its ingredients showed notable antiviral, immune-modulator, and antipyretic properties. Its ingredients are:

Alstonia scholaris R. Br. Aqueous extract of (Saptaparna) Bark-1 part
Picrorhiza Kurroa Royle Aqueous extract of (Kutki) Rhizome-1 part
Swertia chirata Buch-Ham. Aqueous extract of (Chirata) Whole plant-1 part
Caesalphinia crista, Linn. Fine powder of seed (Kuberaksha) Pulp-2 parts

The crucial question, of course, is does AYUSH-64 work?

An open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India with 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.

The outcome measures were:

  • the proportion of participants who attained clinical recovery on days 7, 15, 23, and 30,
  • the proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point,
  • change in pro-inflammatory markers,
  • metabolic functions,
  • HRCT chest (CO-RADS category),
  • the incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).

Out of 80 participants, 74 (37 in each group) contributed to the final analysis. A significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. The mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.

The authors concluded that AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

I do object to these conclusions for several reasons:

  1. The study cannot possibly determine the safety of AYUSH-64.
  2. Even for assessing its efficacy, it was too small.
  3. The trial design followed the often-discussed A+B vs B concept and is thus prone to generate false-positive results.

I believe that it is highly irresponsible, during a medical crisis like ours, to conduct studies that can only produce unreliable findings. If there is a real possibility that a therapy might work, we do need to test it, but we should take great care that the test is rigorous enough to generate reliable results. This, I think, is all the more true, if – like in the present case – the study was done with governmental support.

Spondyloptosis is a grade V spondylolisthesis – a vertebra having slipped so far with respect to the vertebra below that the two endplates are no longer congruent. It is usually seen in the lower lumbar spine but rarely can be seen in other spinal regions as well. Spondyloptosis is most commonly caused by trauma. It is defined as the dislocation of the spinal column in which the spondyloptotic vertebral body is either anteriorly or posteriorly displaced (>100%) on the adjacent vertebral body. Only a few cases of cervical spondyloptosis have been reported. The cervical cord injury in most patients is complete and irreversible. In most cases of cervical spondyloptosis, regardless of whether there is a neurologic deficit or not, reduction and stabilization of the fracture-dislocation is the management of choice

The case of a 16-year-old boy was reported who had been diagnosed with spondyloptosis of the cervical spine at the C5-6 level with a neurologic deficit following cervical manipulation by a traditional massage therapist. He could not move his upper and lower extremities, but the sensory and autonomic function was spared. The pre-operative American Spinal Cord Injury Association (ASIA) Score was B with SF-36 at 25%, and Karnofsky’s score was 40%. The patient was disabled and required special care and assistance.

The surgeons performed anterior decompression, cervical corpectomy at the level of C6 and lower part of C5, deformity correction, cage insertion, bone grafting, and stabilization with an anterior cervical plate. The patient’s objective functional score had increased after six months of follow-up and assessed objectively with the ASIA Impairment Scale (AIS) E or (excellent), an SF-36 score of 94%, and a Karnofsky score of 90%. The patient could carry on his regular activity with only minor signs or symptoms of the condition.

The authors concluded that this case report highlights severe complications following cervical manipulation, a summary of the clinical presentation, surgical treatment choices, and a review of the relevant literature. In addition, the sequential improvement of the patient’s functional outcome after surgical correction will be discussed.

This is a dramatic and interesting case. Looking at the above pre-operative CT scan, I am not sure how the patient could have survived. I am also not aware of previous similar cases. This does, however, not mean they don’t exist. Perhaps most affected patients simply died without being diagnosed. So, do we need to add spondyloptosis to the (hopefully) rare but severe complications of spinal manipulation?

This meta-analysis was conducted by researchers affiliated to the Evangelical Clinics Essen-Mitte, Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, Germany. (one of its authors is an early member of my ALTERNATIVE MEDICINE HALL OF FAME). The paper assessed the safety of acupuncture in oncological patients.

The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized controlled trials in oncological patients comparing invasive acupuncture with sham acupuncture, treatment as usual (TAU), or any other active control were eligible. Two reviewers independently extracted data on study characteristics and adverse events (AEs). Risk of bias was assessed using the Cochrane Risk of Bias Tool.

Of 4590 screened articles, 65 were included in the analyses. The authors observed that acupuncture was not associated with an increased risk of intervention-related AEs, nonserious AEs, serious AEs, or dropout because of AEs compared with sham acupuncture and active control. Compared with TAU, acupuncture was not associated with an increased risk of intervention-related AEs, serious AEs, or dropout because of AEs but was associated with an increased risk for nonserious AEs (odds ratio, 3.94; 95% confidence interval, 1.16-13.35; P = .03). However, the increased risk of nonserious AEs compared with TAU was not robust against selection bias. The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.

The authors concluded that the current review indicates that acupuncture is as safe as sham acupuncture and active controls in oncological patients. The authors recommend researchers heed the CONSORT (Consolidated Standards of Reporting Trials) safety and harm extension for reporting to capture the side effects and better investigate the risk profile of acupuncture in oncology.

You might think this article is not too bad. So, why do I feel that this paper is so bad?

One reason is that the authors included evidence up to August 2020. Since then, there must have been hundreds of further papers on acupuncture. The article was therefore out of date before it was published.

But that is by no means my main reason. We know from numerous investigations that acupuncture studies often fail to report AEs (and thus violate publication ethics). This means that this new analysis is merely an amplification of the under-reporting. It is, in other words, a means of perpetuating a wrong message.

Yes, you might say, but the authors acknowledge this; they even state in the abstract that “The meta-analyses may have been biased because of the insufficient reporting of AEs in the original randomized controlled trials.” True, but this fact does not erase the mistake, it merely concedes it. At the very minimum, the authors should have phrased their conclusion differently, e.g.: the current review confirms that AEs of acupuncture are under-reported in RCTs. Therefore, a meta-analysis of RCTs is unable to verify whether acupuncture is safe. From other types of research, we know that it can cause serious AEs.

An even better solution would have been to abandon or modify the research project when they first came across the mountain of evidence showing that RCTs often fail to mention AEs.

As it stands, the conclusion that acupuncture is as safe as sham acupuncture is simply not true. Since the article probably looks sound to naive readers, I feel that is a particularly good candidate for the WORST PAPER OF 2022 COMPETITION.

 

PS

For those who are interested, here are 4 of my own peer-reviewed articles on the safety of acupuncture (much more can, of course, be found on this blog):

  1. Patient safety incidents from acupuncture treatments: a review of reports to the National Patient Safety Agency – PubMed (nih.gov)
  2. Acupuncture–a critical analysis – PubMed (nih.gov)
  3. Prospective studies of the safety of acupuncture: a systematic review – PubMed (nih.gov)
  4. The risks of acupuncture – PubMed (nih.gov)

Anyone who has followed this blog for a while will know that advocates of so-called alternative medicine (SCAM) are either in complete denial about the risks of SCAM or they do anything to trivialize them. Here is a dialogue between a SCAM proponent (P) and a scientist (S) that is aimed at depicting this situation. The conversation is fictitious, of course, but it is nevertheless based on years of experience in discussing these issues with practitioners of various types of SCAM. As we shall see, the arguments turn out to be perfectly circular.

P: My therapy is virtually free of risks.

S: How can you be so sure?

P: I am practicing it for decades and have never seen a single problem.

S: That could have several reasons; perhaps the patients who experience problems did simply not come back.

P: I find this unlikely.

S: I don’t, and I know of reports where patients had serious complications after the type of SCAM you practice.

P: These are isolated case reports. They do not amount to evidence.

S: How do you know they are isolated?

P: They must be isolated because, in the many clinical trials of my therapy available to date, you will not find any evidence of serious adverse effects.

S: That is true, but it has been repeatedly shown that these trials regularly fail to mention side effects altogether.

P: That’s because there aren’t any.

S: Not quite, clinical trials should always mention adverse effects, and if there were none, they should mention this too.

P: So, you admit that you have no evidence that my therapy causes adverse effects.

S: The thing is, I don’t need such evidence. It is you, the practitioners of this therapy, who should provide evidence that your treatments are safe.

P: We did! The complete absence of reports of side effects constitutes that evidence.

S: Except, there is some evidence. I already told you that there are several case reports of serious problems.

P: But case reports are anecdotes; they are no evidence.

S: Look, here is a systematic review of all the case reports. You cannot possibly deny that this is a concern.

P: It’s still merely a bunch of anecdotes, nothing more.

S: Only because your profession does nothing about it.

P: What do you think we need to do about it?

S: Like other professions, you need to systematically record adverse effects.

P: How would that help?

S: It would give us a rough indication of the size and severity of the problem.

P: This sounds expensive and complicated to organize.

S: Perhaps, but it is necessary if you want to be sure that your therapy is safe.

P: But we are sure already!

S: No, you believe it, but you don’t know it.

P: You are getting on my nerves with your obsession. Don’t you know that the true danger in healthcare is the adverse effects of pharmaceutical drugs?

S: But these drugs are also effective.

P: Are you saying my therapy isn’t?

S: What I am saying is that the drugs you claim to be dangerous do more good than harm, while this is not at all clear with your SCAM.

P: To me, that is very clear. My therapy helps many and harms nobody!

S: How do you know that it harms nobody?

 

 

… At this point, we have gone full circle and we can re-start this conversation from its beginning.

 

 

A recent article in LE PARISIEN entitled “L’homéopathie vétérinaire, c’est sans effet… mais pas sans risque” – Veterinary homeopathy is without effect … but not without risk, tells it like it is. Here are a few excerpts that I translated for you.

More than 77% of French people have tried homeopathy in their lifetime. But have you ever given it to your pet? Harmless in most cases, its use can be dangerous when it replaces a treatment whose effectiveness is scientifically proven … from a safety point of view, the tiny granules are indeed irreproachable: their use does not induce any drug interaction or undesirable side effects, nor does it run the risk of overdosing or addiction … homeopathic preparations owe their harmlessness to their lack of proper effects. “Neither in human medicine nor in veterinary medicine, at the current stage, clinical studies of all levels do not provide sufficient scientific evidence to support the therapeutic efficacy of homeopathic preparations”, stated the French Veterinary Academy in May 2021. These conclusions are in line with those of the French Academies of Medicine and Pharmacy, the British Royal College of Veterinary Surgeons, and all the international scientific bodies that have given their opinion on the subject.

Therefore, when homeopathy delays diagnosis or is used in place of proven effective treatments, its use represents a “loss of opportunity” for your pet. The greatest danger of homeopathy is not that the remedies are ineffective, but that some homeopaths believe that their therapies can be used as a substitute for genuine medical treatment,” summarizes a petition to the UK veterinary regulatory body signed by more than 1,000 British veterinarians. At best, this claim is misleading and, at worst, it can lead to unnecessary suffering and death.”

But how can we explain the number of testimonies from pet owners who say that “it works”? “I am very satisfied with the Kalium Bichromicum granules for my cat with an eye ulcer, which is healing very well”… These improvements, real or supposed, can be explained by “contextual effects”, among which the famous placebo effect (which is not specific to humans), your subjective interpretation of his symptoms, or the natural history of the disease.

When these contextual effects are ignored or misunderstood, the spontaneous resolution or reduction of the disease can be wrongly attributed to homeopathy, and thus maintain the illusion of its effectiveness. This confusion is all the more likely because homeopathy owes much of its popularity to its use to treat “everyday ailments”: nausea, allergies, fatigue, bruises, nervousness, etc., which tend to get better on their own with time, or which have a fluctuating expression…

In April 2019, the association published an open letter addressed to the National Council of the Order of Veterinarians, calling on it to take a position on the compatibility of homeopathy with the “ethical and scientific requirements” of the profession. The organization, whose official function is to guarantee the quality of the service rendered to the public by the 20,000 veterinarians practicing in France, issued its conclusions last October. It invited veterinary training centers to remove homeopathy from their curricula, under penalty of having their accreditation withdrawn, and thus their ability to deliver training credits.

In my view, this is a remarkably good and informative text. How often do homeopathy fans claim IT WORKS FOR ANIMALS AND THUS CANNOT BE A PLACEBO! The truth is that, as we have so often discussed on this blog, homeopathy does not work beyond placebo for animals. This renders veterinary homeopathy:

  • a waste of money,
  • potentially dangerous,
  • in the worst cases a form of animal abuse.

My advice is that, as soon as a vet recommends homeopathy, you look for the exit.

During the last two years, I have written more often than I care to remember about the numerous links between so-called alternative medicine (SCAM) and COVID-19 vaccination hesitancy. For instance:

Whenever I publish a post on these subjects, some enthusiasts of SCAM argue that, despite all this evidence, they are not really against COVID vaccinations. But who is correct? What proportions of SCAM practitioners are pro or contra? One way to find out is to check how they themselves behave. Do they get vaccinated or not?

Here are some recent data from Canada that seem to provide an answer.

A breakdown of vaccination rates among Canadian healthcare professions has been released, based on data gathered from 17 of B.C.’s 18 regulated colleges. The findings are most revealing:

  • dieticians, physicians, and surgeons lead the way, with vaccination rates of 98%,
  • occupational therapists were at 97%,
  • Chinese medicine practitioners and acupuncturists were at 79%,
  • chiropractors at 78%
  • naturopaths at 69%.

The provincial health officer Dr. Bonnie Henry said the province is still working with the colleges on how to notify patients about their practitioner’s vaccination status. “We are working with each college on how to build it into professional standards. The overriding principle is patient status,” she told a news conference. “It may be things like when you call to book, you are asked whether you would prefer to see a vaccinated or unvaccinated professional. We are trying to protect privacy and provide agency to make the decision.”

______________________

As far as I am aware, these are unique data. It would be interesting to see additional evidence. If anyone knows about vaccination rates in other countries of acupuncturists, herbalists, homeopaths, osteopaths, Heilpraktiker, etc. I would love to learn more.

Harad Matthes, the boss of the anthroposophical Krankenhaus Havelhoehe and professor for Integrative and Anthroposophical Medicine at the Charite in Berlin, has featured on my blog before (see here and here). Now he is making headlines again.

Die Zeit‘ reported that Matthes went on German TV to claim that the rate of severe adverse effects of COVID-19 vaccinations is about 40 times higher than the official figures indicate. In the MDR broadcast ‘Umschau’ Matthes said that his unpublished data show a rate of 0,8% of severe adverse effects. In an interview, he later confirmed this notion. Yet, the official figures in Germany indicate that the rate is 0,02%.

How can this be?

Die ZEIT ONLINE did some research and found that Matthes’ data are based on extremely shoddy science and mistakes. The Carite also distanced themselves from Matthes’ evaluation: “The investigation is an open survey and not really a scientific study. The data are not suitable for drawing definitive conclusions regarding incidence figures in the population that can be generalized” The problems with Matthes’ ‘study’ seem to be sevenfold:

  1. The data are not published and can thus not be scrutinized.
  2. Matthes’ definition of a severe adverse effect is not in keeping with the generally accepted definition.
  3. Matthes did not verify the adverse effects but relied on the information volunteered by people over the Internet.
  4. Matthes’ survey is based on an online questionnaire accessible to anyone. Thus it is wide open to selection bias.
  5. The sample size of the survey is around 10 000 which is far too small for generalizable conclusions.
  6. There is no control group which makes it impossible to differentiate a meaningful signal from mere background noise.
  7. The data contradict those from numerous other studies that were considerably more rigorous.

Despite these obvious flaws Matthes insisted in a conversation with ZEIT ONLINE that the German official incidence figures are incorrect. As Germany already has its fair share of anti-vaxxers, Matthes’ unfounded and irresponsible claims contribute significantly to the public sentiments against COVID vaccinations. They thus endangering public health.

In my view, such behavior amounts to serious professional misconduct. I, therefore, feel that his professional body, the Aerztekammer, should look into it and prevent further harm.

I just stumbled over a paper we published way back in 1997. It reports a questionnaire survey of all primary care physicians working in the health service in Devon and Cornwall. Here is an excerpt:

Replies were received from 461 GPs, a response rate of 47%. A total of 314 GPs (68%, range 32-85%) had been involved in complementary medicine in some way during the previous week. One or other form of complementary medicine was practised by 74 of the respondents (16%), the two most common being homoeopathy (5.9%) and acupuncture (4.3%). In addition, 115 of the respondents (25%) had referred at least one patient to a complementary therapist in the previous week, and 253 (55%) had endorsed or recommended treatment with complementary medicine. Chiropractic, acupuncture and osteopathy were rated as the three most effective therapies, and the majority of respondents believed that these three therapies should be funded by the health service. A total of 176 (38%) respondents reported adverse effects, most commonly after manipulation.

What I found particularly interesting (and had totally forgotten about) were the details of these adverse effects: Serious adverse effects of spinal manipulation included the following:

  • paraplegia,
  • spinal cord transection,
  • fractured vertebra,
  • unspecified bone fractures,
  • fractured neck of femur,
  • severe pain for years after manipulation.

Adverse effects not related to manipulation included:

  • death after a coffee enema,
  • liver toxicity,
  • anaphylaxis,
  • 17 cases of delay of adequate medical attention,
  • 11 cases of adverse psychological effects,
  • 14 cases of feeling to have wasted money.

If I remember correctly, none of the adverse effects had been reported anywhere which would make the incidence of underreporting 100% (exactly the same as in a survey we published in 2001 of adverse effects after spinal manipulations).

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