MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bogus claims

1 2 3 48

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!!!

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.

A sizeable proportion of the general population is convinced that certain moon phases and moon signs may impact their health as well as the onset and clinical course of diseases. Those who believe in alternative medicine tend, I guess, to belong to this group. Here is a quote from one of the many websites making such claims: Understanding moon cycles and how they affect the body can be a key to better health. To understand how the moon influences your health the first step is to realize that your human body is made up of over 60% water, and the moon affects all water on the Earth.  The moon controls the ebb and flow of the oceanic tides and it controls your human body in the same way.

There is, of course, no plausible reason for such claims and convictions, but this rarely stops the gullible. And anyway, it could be true – or couldn’t it?

This study investigated the perioperative and long-term outcome of living donor kidney transplantation (LDKT) dependent on moon phases and zodiac signs. Patient data were prospectively collected in a continuously updated kidney transplant database. Two hundred and seventy-eight consecutive patients who underwent LDKT between 1994 and December 2009 were selected for the study and retrospectively assigned to the four moon phases (new-moon, waxing-moon, full-moon, and waning-moon) and the corresponding zodiac sign (moon sign Libra), based on the date of transplantation. Pre-existing comorbidities, perioperative mortality, surgical outcome, and long-term survival data were analysed.

Of all LDKT procedures, 11.9; 39.9; 11.5; and 36.5% were performed during the new, waxing, full, and waning moon, respectively, and 6.2% during the moon sign Libra, which is believed to interfere with renal surgery. Survival rates at 1, 5, and 10 years after transplantation were 98.9, 92, and 88.7% (patient survival) and 97.4, 91.6, and 80.6% (graft survival) without any differences between all groups of lunar phases and moon signs. Overall perioperative complications and early graft loss occurred in 21.2 and 1.4%, without statistical difference (p > 0.05) between groups.

The authors concluded that moon phases and the moon sign Libra had no impact on early and long-term outcome measures following LDKT in our study. Thus, concerns of patients awaiting LDKT regarding the ideal time of surgery can be allayed, and surgery may be scheduled independently of the lunar phases.

The authors also concede that their study has some limitations. First, it is a retrospective analysis of a single transplant centre and the number of patients is not huge. In addition, due to the retrospective design of the study, no randomization of the patients was possible. However, a randomization of the patients would systematically ignore the patients preferences. Realization of such a randomized trial would therefore be challenging. As a consequence, we do not know in how many cases the transplant was scheduled according to the lunar phases on the explicit request of the patient. It would be interesting to know whether a strong desire of the patient and a corresponding fulfilment has any influence on the short- and long-term success of the surgery.

Nonsense, I hear the loonies shout: there are numerous studies confirming that the moon has a definite effect on our health!

How do you explain that?

I think there are at least two possible explanations:

  1. these studies were methodologically flawed and lack independent replications;
  2. it cannot be excluded that patients’ fear of the wrong moon-phase might exert a negative influence on their health, irrespective of any influence of the moon. In this case, the moon-phase itself would be irrelevant, but the fear would mimic a real phenomenon.

Politics, politicians and medicine has always been an intriguing mix, particularly when it comes to homeopathy (see for instance here and here).

A recent article in the ‘Navhind Times’ is an excellent reminder of this fact.

Here are a few excerpts:

… Town and Country Planning Minister Vijai Sardesai,  on Saturday, appealed to the homeopaths  participating in the All-India  Homoeopathic Scientific Seminar: “If the historic seminar is able to find a conclusive solution to our most endemic issue (kidney  disease), then we  think it would do a  big thing to the  state government and the people of Goa as a whole. Given the failure of the conventional medicines, we now have the alternative homoepathic medicines… Sometimes conventional  methods  don’t  give you solutions. It requires alternative methods just like in politics. So in the medicine, when  conventional  methods  fail and the clueless about issues affecting  certain section of the population of the progressive state, homoeopathy is the answer,’’ he added. Sardesai further opined that homoeopathy  “understands the healing  mechanism of the body and Goa has  slowly accepted it. Today,  Goa has AYUSH Minister in Sripad Naik.  I am hopeful that the people of Goa will switch to  homoeopathic  from allopathic. We pledge fullest support to it,’’ he declared gaining applause from the doctors across the country.

The  national  president of the  Homoeopathic Medical Association of India (HMAI) Dr Bhaskar  Bhatt said that the homoeopaths has a bright  future if they stick to their science of homoeopathy and work hard. Dr Bhatt said that the negative publicity for the  homoeopathy is also getting translated into positive awareness for it.

END OF QUOTES

And there we have been doubting that homeopathy has any value at all!

How could we?

If politicians say that homeopaths understand the healing mechanism of the body, who are we scientists to disagree?

If politicians advise us to abandon allopathy and switch to homeopathy, who would not follow blindly their superior wisdom?

Shinrin-yoku means “taking in the forest atmosphere” or “forest bathing.” It was developed in Japan during the 1980s and has, according to its proponents, become a cornerstone of preventive health care and healing in Japanese medicine. Researchers primarily in Japan and South Korea have established a robust body of scientific literature on the health benefits of spending time under the canopy of a living forest… there have been many scientific studies that are demonstrating the mechanisms behind the healing effects of simply being in wild and natural areas. (some of this research is available here). For example, many trees give off organic compounds that support our “NK” (natural killer) cells that are part of our immune system’s way of fighting cancer.

The claimed benefits of Shinrin-yoku are remarkable:

  • Boosted immune system functioning, with an increase in the count of the body’s Natural Killer (NK) cells.
  • Reduced blood pressure
  • Reduced stress
  • Improved mood
  • Increased ability to focus, even in children with ADHD
  • Accelerated recovery from surgery or illness
  • Increased energy level
  • Improved sleep
  • Deeper and clearer intuition
  • Increased flow of energy
  • Increased capacity to communicate with the land and its species
  • Increased flow of eros/life force
  • Deepening of friendships
  • Overall increase in sense of happiness

But is any of this really true?

The aim of this state-of-the-art review was to summarise empirical research conducted on the physiological and psychological effects of Shinrin-Yoku. Research published from 2007 to 2017 was considered. A total of 64 studies met the inclusion criteria. According to the authors, they show that health benefits associated with the immersion in nature continue to be currently researched. Longitudinal research, conducted worldwide, is needed to produce new evidence of the relationships associated with Shinrin-Yoku and clinical therapeutic effects. Nature therapy as a health-promotion method and potential universal health model is implicated for the reduction of reported modern-day “stress-state” and “technostress.”

Odd?

Yes!

A look at the primary studies reveals that they are usually small and of poor quality.

Perhaps a brand new  review aimed more specifically at evaluating preventive or therapeutic effects of Shinrin-Yoku on blood pressure can tell us more. The authors considered all published, randomized, controlled trials, cohort studies, and comparative studies that evaluated the effects of the forest environment on changes in systolic blood pressure. Twenty trials involving 732 participants were reviewed. Systolic and diastolic blood pressure of patients submitted to the forest environment was significantly lower than that of controls. The authors concluded that this systematic review shows a significant effect of Shinrin-yoku on reduction of blood pressure.

I find this paper odd as well:

  • it lacks important methodological detail;
  • the authors included not just controlled clinical trials but all sorts of ‘studies’;
  • there is no assessment of the methodological rigor of the primary trials (from what I could see, they were mostly too poor to draw any conclusions from them).

What does all of this mean?

I have no problems in assuming that relaxation in a forest is beneficial in many ways and a nice experience.

But why call this a therapy?

It is relaxation!

Why make so many unsubstantiated claims?

And why study it in such obviously flawed ways?

All this does, I fear, is giving science a bad name.

I recently came across this article; essentially it claims that, in 1918, chiropractic proved itself to be the method of choice for treating the flu!

Unbelievable?

Here is a short quote from it:

Chiropractors got fantastic results from influenza patients while those under medical care died like flies all around. Statistics reflect a most amazing, almost miraculous state of affairs. The medical profession was practically helpless with the flu victims but chiropractors seemed able to do no wrong.”

“In Davenport, Iowa, 50 medical doctors treated 4,953 cases, with 274 deaths. In the same city, 150 chiropractors including students and faculty of the Palmer School of Chiropractic, treated 1,635 cases with only one death.”

“In the state of Iowa, medical doctors treated 93,590 patients, with 6,116 deaths – a loss of one patient out of every 15. In the same state, excluding Davenport, 4,735 patients were treated by chiropractors with a loss of only 6 cases – a loss of one patient out of every 789.

“National figures show that 1,142 chiropractors treated 46,394 patients for influenza during 1918, with a loss of 54 patients – one out of every 886.”

“Reports show that in New York City, during the influenza epidemic of 1918, out of every 10,000 cases medically treated, 950 died; and in every 10,000 pneumonia cases medically treated 6,400 died. These figures are exact, for in that city these are reportable diseases.”

“In the same epidemic, under drugless methods, only 25 patients died of influenza out of every 10,000 cases; and only 100 patients died of pneumonia out of every 10,000 cases…”

“In the same epidemic reports show that chiropractors in Oklahoma treated 3,490 cases of influenza with only 7 deaths. But the best part of this is, in Oklahoma there is a clear record showing that chiropractors were called in 233 cases where medical doctors had cared for the patients, and finally gave them up as lost. The chiropractors saved all these lost cases but 25.”

END OF QUOTE

So what does that sort of ‘evidence’ really show?

Does it prove that chiropractic is effective against influenza?

No!

Does it even suggest that chiropractic is effective against influenza?

No!

What then?

I think it shows that some chiropractors (like many homeopaths) are deluded to a point where they are unable to differentiate pseudoscience from science, anecdote from evidence, cause from effect, etc.

In the case you need more explanations, let me re-phrase this section from a previous post:

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated by chiropractors, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that chiropractic works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless.

The TIMES HIGHER EDUCATION (THE) reported yesterday that the British School of Osteopathy (BSO) has won university college title, meaning that it could be on the road towards full university status. University college title, awarded by the Privy Council on the advice of the Department for Education (DfE) and the Higher Education Funding Council for England, is usually seen as a step towards full university status. The London-based BSO already secured degree-awarding powers and access to Hefce public teaching and research funding in 2015. The BSO will be known, from September, as the University College of Osteopathy.

The THE quoted me saying “Osteopathy is based on implausible assumptions, and there is no good evidence for its effectiveness. Yet osteopaths regularly make all sorts of therapeutic claims. These facts make the BSO not a candidate for becoming a university; on the contrary, such a move would significantly downgrade the credibility of UK universities and make a mockery of academia and evidence-based healthcare.”

Charles Hunt, the BSO principal, responded: “We recognise that for some of the things that some osteopaths are doing, there is very limited evidence [to demonstrate their effectiveness], and we need to gain more for that. But within medicine, there’s a lot of things that also do not have evidence for them, but some medical practitioners are doing [them anyway].”

What???

The BSO principal should offer a course on logical fallacies and enlist as the first student in it, I thought when reading his response.

Anyway, having stated that “osteopaths regularly make all sorts of therapeutic claims”, I better provide some evidence. Perhaps another occasion for a slide-show?

Here are a few images I found on Twitter that are relevant in this context.

[please click to see them full size]
1 2 3 48

Gravityscan Badge

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories