MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

Monthly Archives: September 2017

The claims that are being made for the health benefits of Chinese herbal medicine are impressive. I am not sure that there is even a single human disease that is not alleged to be curable with the use of some Chinese herbal mixture. I find this worrying because some patients might actually believe such outrageous nonsense, particularly since Chinese researchers seem to bend over backwards to support them with science… or should I say pseudoscience?

This study was aimed at evaluating the association between mortality rate and early use of Chinese herbal products (CHPs) among patients with lung cancer. The researchers conducted a retrospective cohort study based on the National Health Insurance Research Database, Taiwan Cancer Registry, and Cause of Death Data. Patients with newly diagnosed lung cancer between 2002 and 2010 were classified as either the CHP (n = 422) or the non-CHP group (n = 2828) based on whether they used CHP within 3 months after first diagnosis of lung cancer. A Cox regression model was used to examine the hazard ratio (HR) of death for propensity score (PS) matching samples.

After PS matching, average survival time of the CHP group was significantly longer than that of the non-CHP group. The adjusted HR (0.82; 95% CI: 0.73-0.92) in the CHP group was lower than the non-CHP group. Stratified by clinical cancer stages, CHP group had longer survival time in the stage 3 subgroup. When the exposure period of CHP use was changed from 3 to 6 months, results remained similar.

The authors concluded that results indicated that patients with lung cancer who used CHP within 3 months after first diagnosis had a lower hazard of death than non-CHP users, especially for stage 3 lung cancer. Further experimental studies are needed to examine the causal relationship.

I would argue the direct opposite: further studies along these lines would be a waste of time!

I can name numerous reasons for this, for example:

  • Investigating CHP as though it is one entity is nonsense. There are thousands of different CHPs; some are placebos; some are toxic; and a few might even have some health effects.
  • The observed effect is almost certainly an artefact; the matching of the groups might have been sub-optimal; the CHP group differed systematically from the control group, for instance, by adhering to a healthier life-style; etc, etc.

All of this should be so obvious that it hardly deserves a mention. Why then do the authors not point it out prominently and clearly? Why did they ever embark on such a fatally flawed project? I cannot be sure, of course, … but perhaps one possible answer might be that the lead author is affiliated to a Department of Chinese Medicine?

 

I have often remarked on the fact that, in alternative medicine, more surveys get published than in any other medical field. Typically these surveys are not just useless but overtly counter-productive:

  • they tend to be of very poor quality;
  • their results are not generalizable and thus meaningless;
  • they show that a sizable proportion of the population uses alternative therapies, pay out of their own pocket for them, and are satisfied with them;
  • the authors then state that it must be unfair that only the affluent can benefit from alternative medicine;
  • eventually, the conclusion is reached that alternative medicine should be paid for by the healthcare system and be free for all at the point of usage.

Therefore, I find that it is a waste of time to even read surveys of alternative medicine usage. But every now and then, one does come along that is worth discussing – like this one, for instance.

The survey evaluated dietary supplements (DS) usage by US adults aged ≥60 y to characterize the use of DSs, determine the motivations for use, and examine the associations between the use of DSs and selected demographic, lifestyle, and health characteristics. Data from 3469 older adults aged ≥60 y from the 2011-2014 NHANES were analyzed. DSs used in the past 30 d were ascertained via an interviewer-administered questionnaire in participants’ homes. The prevalence of overall DS use and specific types of DSs were estimated. The number of DSs reported and the frequency, duration, and motivation(s) for use were assessed. Logistic regression models were constructed to examine the association between DS use and selected characteristics.

Seventy percent of older adults reported using ≥1 DS in the past 30 d; 54% of users took 1 or 2 products, and 29% reported taking ≥4 products. The most frequently reported products were multivitamin or mineral (MVM) (39%), vitamin D only (26%), and omega-3 fatty acids (22%). Women used DSs almost twice as often as men. Those not reporting prescription medications were less likely to take a DS than those reporting ≥3 prescription medications. The most frequently reported motivation for DS use was to improve overall health (41%).

The authors concluded that the use of DSs among older adults continues to be high in the United States, with 29% of users regularly taking ≥4 DSs, and there is a high concurrent usage of them with prescription medications.

I find these data impressive – but not in a positive sense, I hasten to add.

The level of DS use in the US is staggering. Considering that 90% (my estimate) of the supplements are completely useless, the amount of money that is being wasted is huge. Even more concerning is the frequency of drug interactions that are being provoked by DS-intake.

And what’s the solution?

Obviously, it is better information for consumers (which is easier said than done – but I am trying my best!).

The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who

  • strictly prescribe conventional medicines (GP-CM),
  • regularly prescribe homeopathy in a mixed practice (GP-Mx),
  • or are certified homeopathic GPs (GP-Ho).

The investigation was an epidemiological cohort study of general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.

Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group, but not for the GP-Mx group.

The authors concluded that patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians’ management and patients’ preferences as well as statistical regression to the mean.

Aren’t we glad they added the last sentence to their conclusion!!!

Without it, one might have thought that the observed differences were due to the homeopathic remedies. In fact, the finding amounts to a self-fulfilling prophecy: Homeopaths tend to be against prescribing conventional drugs. This means that patients consulting homeopaths are bound to use less drugs than patients who consult conventional doctors. In that sense, the study was like monitoring whether consumers who go to the butchers buy more meat than those shopping in a shop for vegetarians.

The only result that requires a more serious consideration is that homeopathically treated patients experienced more clinical improvement than those treated conventionally. But even this difference is not hard to explain: firstly, the difference was merely marginal; secondly, patients with ADD are bound to respond particularly well to the empathetic and long therapeutic encounter most homeopaths offer. In other words, the difference had nothing to do with the alleged effectiveness of the homeopathic remedies.

Mastitis is a common disease in dairies. Numerous non-antimicrobial drugs and treatment strategies have been recommended for this condition. Homeopaths in particular have long claimed that their highly diluted remedies are an effective option, and I have reported repeatedly about the evidence – see here, here, and here, for instance. Even though it is far from positive, evangelic homeopaths like our friend Dana Ullman or naïve quackery-fans like Prince Charles claim that it is “as effective as antibiotics, the mastitis treatment of choice”.

So, who is right?

I am biased, homeopaths insist.

Ullman is a joke, any rational thinker must admit.

Prince Charles? … no comment.

What we need is an independent body to look at the data.

A new systematic review did exactly that. Its authors are highly respected and come from institutions that are not likely to promote bogus claims:

  • Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
  • Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
  • Canadian Bovine Mastitis and Milk Quality Research Network, Canada
  • Canadian Bovine Mastitis and Milk Quality Research Network, Canada
  • Sherbrooke Research and Development Centre, Agriculture and Agri-Food Canada
  • Canadian Bovine Mastitis and Milk Quality Research Network, Canada
  • Département de Pathologie et Microbiologie, Faculté de Médecine Vétérinaire, Université de Montreal, Canada.

It was performed with studies written in English or French selected from CAB Abstracts, PubMed, and Web of Science. All treatments other than conventional antimicrobials for clinical mastitis during lactation were retained. Only studies comparing the treatment under investigation to a negative or positive control, or both, were included. Outcomes evaluated were clinical and bacteriological cure rates and milk production. Selection of the study, data extraction, and assessment of risk of bias was performed by 3 reviewers. Assessment of risk of bias was evaluated using the Cochrane Collaboration tool for systematic review of interventions.

A total of 2,451 manuscripts were first identified and 39 manuscripts corresponding to 41 studies were included. Among these, 22 were clinical trials, 18 were experimental studies, and one was an observational study. The treatments evaluated were conventional anti-inflammatory drugs (n = 14), oxytocin with or without frequent milk out (n = 5), biologics (n = 9), homeopathy (n = 5), botanicals (n = 4), probiotics (n = 2), and other alternative products (n = 2). All trials had at least one unclear or high risk of bias. Most trials (n = 13) did not observe significant differences in clinical or bacteriological cure rates in comparison with negative or positive controls. Few studies evaluated the effect of treatment on milk yield. In general, the power of the different studies was very low, thus precluding conclusions on non-inferiority or non-superiority of the treatments investigated. No evidence-based recommendations could be given for the use of an alternative or non-antimicrobial conventional treatment for clinical mastitis.

The authors concluded that homeopathic treatments are not efficient for management of clinical mastitis.

Will this finally stop homeopaths from claiming that their placebos work for mastitis?

I would not count on it!

The European Academies Science Advisory Council (EASAC) is an umbrella organization representing 29 national and international scientific academies in Europe, including the Royal Society (UK) and Royal Swedish Academy of Sciences. One of its aims is to influence policy and regulations across the European Union. Now, the EASAC has issued an important and long-awaited verdict on homeopathy:

The EASAC is publishing this Statement to build on recent work by its member academies to reinforce criticism of the health and scientific claims made for homeopathic products. The analysis and conclusions are based on the excellent science-based assessments already published by authoritative and impartial bodies. The fundamental importance of allowing and supporting consumer choice requires that consumers and patients are supplied with evidence-based, accurate and clear information. It is, therefore, essential to implement a standardised, knowledge-based regulatory framework to cover product efficacy, safety and quality, and accurate advertising practices, across the European Union (EU). Our Statement examines the following issues:

  • Scientific mechanisms of action—where we conclude that the claims for homeopathy are implausible and inconsistent with established scientific concepts.
  • Clinical efficacy—we acknowledge that a placebo effect may appear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect.

There are related concerns for patient-informed consent and for safety, the latter associated with poor quality control in preparing homeopathic remedies. Promotion of homeopathy—we note that this may pose significant harm to the patient if incurring delay in seeking evidence-based medical care and that there is a more general risk of undermining public confidence in the nature and value of scientific evidence. Veterinary practice—we conclude similarly that there is no rigorous evidence to
substantiate the use of homeopathy in veterinary medicine and it is particularly worrying when such products are used in preference to evidence-based medicinal products to treat livestock infections. We make the following recommendations.

1. There should be consistent regulatory requirements to demonstrate efficacy, safety and quality of all products for human and veterinary medicine, to be based on verifiable and objective evidence, commensurate with the nature of the claims being made. In the absence of this evidence, a product should be neither approvable nor registrable by national regulatory agencies for the designation medicinal product.

2. Evidence-based public health systems should not reimburse homeopathic products and practices unless they are demonstrated to be efficacious and safe by rigorous testing.

3. The composition of homeopathic remedies should be labelled in a similar way to other health products available: that is, there should be an accurate, clear and simple description of the ingredients and their amounts present in the formulation.

4. Advertising and marketing of homeopathic products and services must conform to established standards of accuracy and clarity. Promotional claims for efficacy, safety and quality should not be made without demonstrable and reproducible evidence.

END OF QUOTE

No comment needed!!!

It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?

As with any gift, one ought to ask what precisely it is for. If someone made a donation to research aimed at showing that climate change is a hoax, that white supremacy is justified, or that Brexit is going to give Brits their country back, I doubt that it would be a commendable thing. My point is that research must always be aimed at finding the truth and discovering facts. Research that is guided by creed, belief or misinformation is bound to be counter-productive, and a donation to such activities is likely to be detrimental.

Back to the Samuelis! The story goes that Susan once had a cold, took a homeopathic remedy, and subsequently the cold went away. Ever since, the two Samuelis have been supporters not just of homeopathy but all sorts of other alternative therapies. I have previously called this strikingly common phenomenon an ‘epiphany‘. And the Samuelis’ latest gift is clearly aimed at promoting alternative medicine in the US. We only need to look at what their other major donation in this area has achieved, and we can guess what is now going to happen at UCI. David Gorski has eloquently written about the UCI donation, and I will therefore not repeat the whole, sad story.

Instead I want to briefly comment on what, in my view, should happen, if a wealthy benefactor donates a large sum of money to medical research. How can one maximise the effects of such a donation? Which areas of research should one consider? I think the concept of prior probability can be put to good use in such a situation. If I were the donor, I would convene a panel of recognised experts and let them advise me where there are the greatest chances of generating important breakthroughs. If one followed this path, alternative medicine would not appear anywhere near the top preferences, I dare to predict.

But often, like in the case of the Samuelis, the donors have concrete ideas about the area of research they want to invest in. So, what could be done with a large sum in the field of alternative medicine? I believe that plenty of good could come it. All one needs to do is to make absolutely sure that a few safeguards are in place:

  • believers in alternative medicine must be kept out of any decisions processes;
  • people with a solid background in science and a track-record in critical thinking must be put in charge;
  • the influence of the donor on the direction of the research must be minimised as much as possible;
  • a research agenda must be defined that is meaningful and productive (this could include research into the risks of alternative therapies, the ethical standards in alternative medicine, the fallacious thinking of promoters of alternative medicine, the educational deficits of alternative practitioners, the wide-spread misinformation of the public about alternative medicine, etc., etc.)

Under all circumstances, one needs to avoid that the many pseudo-scientists who populate the field of alternative or integrative medicine get appointed. This, I fear, will not be an easy task. They will say that one needs experts who know all about the subtleties of acupuncture, homeopathy, energy-healing etc. But such notions are merely smoke-screens aimed at getting the believers into key positions. My advice is to vet all candidates using my concept of the ‘trustworthiness index’.

How can I be so sure? Because I have been there, and I have seen it all. I have researched this area for 25 years and published more about it than any of the untrustworthy believers. During this time I trained about 90 co-workers, and I have witnessed one thing over and over again: someone who starts out as a believer, will hardly ever become a decent scientist and therefore never produce any worthwhile research; but a good scientist will always be able to acquire the necessary knowledge in this or that alternative therapy to conduct rigorous and meaningful research.

So, how should the UCI spend the $ 200 million? Apparently the bulk of the money will be to appoint 15 faculty chairs across medicine, nursing, pharmacy and population health disciplines. They envisage that these posts will go to people with expertise in integrative medicine. This sounds extremely ominous to me. If this project is to be successful, these posts should go to scientists who are sceptical about alternative medicine and their main remit should be to rigorously test hypotheses. Remember: testing a hypothesis means trying everything to show that it is wrong. Only when all attempts to do so have failed can one assume that perhaps the hypothesis was correct.

My experience tells me that experts in integrative medicine are quite simply intellectually and emotionally incapable of making serious attempts showing that their beliefs are wrong. If the UCI does, in fact, appoint people with expertise in integrative medicine, it is, I fear, unavoidable that we will see:

  • research that fails to address relevant questions;
  • research that is of low quality;
  • promotion masquerading as research;
  • more and more misleading findings of the type we regularly discuss on this blog;
  • a further boost of the fallacious concept of integrative medicine;
  • a watering down of evidence-based medicine;
  • irreversible damage to the reputation of the UCI.

In a nutshell, instead of making progress, we will take decisive steps back towards the dark ages.

Researchers from Texas have recently shown that the administration of hdc Lactobacillus reuteri in the gut resulted in luminal hdc gene expression and histamine production in the intestines of Hdc mice.

Would you conclude from this result that human colon cancer can be reversed or prevented by consuming probiotics?

Probably not!

You would need to be a moron to do so, in my view.

But this did not stop my favourite source of misinformation, WDDTY, to publish an article about this very study entitled “Probiotics could reverse colon cancer”. Here it is:

Colon cancer could be reversed just with probiotics that change the gut’s bacteria—and the disease can be prevented in the first place by eating whole grains, such as brown rice and whole-wheat bread, every day, two new research studies have found. In a breakthrough study that could herald in a new drugs-free approach to treating colon cancer, researchers have discovered that sufferers lack certain enzymes known as metabolites, simple ‘building-block’ compounds, in their gut, and this can cause inflammation and cancer…

Amazed?

Shocked?

I am not! By now, I know what to expect from my favourite source of misinformation, WDDTY.

Insomnia is a ‘gold standard’ indication for alternative therapies of all types. In fact, it is difficult to find a single of these treatments that are not being touted for this indication. Consequently, it has become a nice little earner for alternative therapists (hence ‘gold standard’).

But how good is the evidence suggesting that any alternative therapy is effective for insomnia?

Whenever I have discussed this issue on my blog, the conclusion was that the evidence is less than convincing or even negative. Similarly, whenever I conducted proper systematic reviews in this area, the evidence turned out to be weak or negative. Here are four of the conclusions we drew at the time:

“But this ERNST fellow cannot be trusted, he is not objective!”, I hear some of my detractors shout.

But is he really?

Would an independent, high-level panel of experts arrive at more positive conclusions?

Let’s find out!

This European guideline for the diagnosis and treatment of insomnia recently provided recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations.

The findings and recommendations are as follows:

  • Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence).
  • A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence).
  • Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence).
  • Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation, very-low-quality evidence).

I think, I can rest my case.

The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.

This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.

The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.

The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.

The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.

The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base. 

The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:

  • the natural history of the conditions that were being treated;
  • the conventional therapies the soldiers received;
  • the regression to the mean;
  • social desirability;
  • placebo effects.

In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.

Yesterday, I received this email from my favourite source of misleading information.

Here it is

Dear Friend,

We wanted to tell you about an unprecedented event that you won’t want to miss: the world’s largest Peace Intention Experiment that’s ever been conducted, webcast FREE on GAIA TV from September 30-October 5. It’s being hosted by Lynne McTaggart. You may know Lynne as the editor of WDDTY as well as books like THE FIELD, THE INTENTION EXPERIMENT, and her new book, THE POWER OF EIGHT. But she’s also architect of The Intention Experiments, a series of web-based experiments inviting thousands of her worldwide readers to test the power of thoughts to heal the world. Lynne has run numerous Peace Intention Experiments around the world – all with positive effects – but this time, she’s targeting America, in hopes of lowering violence and helping to end the country’s polarized society. These webcasts will be broadcast around the world, and best of all, they’re FREE for anyone to participate in. You’ll be joining tens of thousands of like-minded souls from around the world taking part in a LIVE Intention Experiment, and a team of prestigious scientists will monitor the effects…

END OF QUOTE

I must admit that I have been worried about world peace in recent months. One lunatic with nuclear power is enough to scare any rational thinker – but it seems, we currently have two!

After reading about Lynne’s experiment, I am not less but more worried.

Why?

Because, as far as I can see, she always gets things badly wrong.

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