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

pseudo-science

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Doctor Jens Wurster is no stranger to this blog; previously I discussed his claim that he has treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases. So far, his claims were based not on evidence published in peer-reviewed journals (I cannot find a single Medline-listed paper by this man); but now Wurster has published an article in a German Journal (Wurster J. Zusatznutzen der Homöopathie … Deutsche Zeitschrift für Onkologie 2018; 50: 85–91; not Medline-listed, I am afraid). The paper is in German, but it has an English abstract; here it is:

____________________________________________________________________________

All over the world, oncology patients receive homeopathic treatment concomitant to conventional treatments, such as chemotherapy and radiation treatment, in order to reduce the side effects of these therapies. It has been shown that cancer patients, who are receiving homeopathic treatment in addition to conventional therapies, have a higher quality of life and a longer survival rate. Studies in cancer cell research have shown the direct effects of highly potentized homeopathic medicines on tumor cell lines. Tumor inhibiting properties of homeopathic medicines have been proven in vivo as well as in vitro. Research projects into complementary medicine (CAMbrella) and research into personalized immunotherapies as well as additive homeopathy open the door to the future of integrative oncology.

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In the article, Wurster states that he has 20 years of experience in treating cancer with homeopathy as an add-on to conventional care, and that he can confirm homeopathy’s effectiveness. He claims that ‘very many’ patients have thus benefitted by experiencing less side-effects of conventional treatments. And he offers two case-reports to illustrate this.

[Nach 20 Jahren klinischer Erfahrung in der Clinica St. Croce im Tessin mit der Behandlung onkologischer Patienten mithilfe der Homöopathie können wir deutlich den Zusatznutzen der Homöopathie in der Onkologie bestätigen [1]. So gelang es unserem Ärzteteam in den zurückliegenden Jahren bei sehr vielen Patienten, durch gezielten Einsatz homöopathischer Mittel die Nebenwirkungen von Chemotherapien oder Bestrahlungen erfolgreich zu reduzieren [1]. Wie dabei Schulmedizin und Homöopathie in der Praxis zusammenwirken, zeigt folgendes Beispiel. ([1] Wurster J. Die homöopathische Behandlung und Heilung von Krebs und metastasierten Tumoren. Norderstedt: Books on Demand; 2015)]

The two case-reports lack detail and are less than convincing, in my view. Both patients have had conventional therapies and Wurster claims that his homeopathic remedies reduced their side-effects. There is no way of verifying this claim, and the improvements might have occurred also without homeopathy.

In the discussion section of his paper, Wurster then elaborates that oncologists throughout Europe are now realising the potential of homeopathy. In support he mentions paediatric oncologists in Klagenfurt who managed to spare pain-killers by giving homeopathics. Similarly, at the Inselspital in Bern, they are offering homeopathic consultations to complement conventional treatments.

[Inzwischen haben auch einige Onkologen erkannt, wie eine gezielt eingesetzte homöopathische Behandlung die Nebenwirkungen von Chemotherapien oder Bestrahlungen reduzieren kann. Wir arbeiten inzwischen mit einigen Onkologen aus ganz Europa zusammen, die den Zusatznutzen der Homöopathie in der Onkologie erlebt haben. In der Kinderonkologie in Klagenfurt beispielsweise konnten mithilfe der Homöopathie Schmerzmittel bei den Kindern eingespart werden. Auch am Inselspital Bern werden zusätzliche homöopathische Konsile in der Kinderonkologie angeboten, um die konventionelle Behandlung begleiten zu können [8].]

At this point, Wurster inserts his reference number 8. As several of his references are either books or websites, this reference to an article in a top journal seems interesting. Here is its abstract:

___________________________________________________________________________________

BACKGROUND:

Though complementary and alternative medicine (CAM) are frequently used by children and adolescents with cancer, there is little information on how and why they use it. This study examined prevalence and methods of CAM, the therapists who applied it, reasons for and against using CAM and its perceived effectiveness. Parent-perceived communication was also evaluated. Parents were asked if medical staff provided information on CAM to patients, if parents reported use of CAM to physicians, and what attitude they thought physicians had toward CAM.

STUDY DESIGN:

All childhood cancer patients treated at the University Children‘s Hospital Bern between 2002-2011 were retrospectively surveyed about their use of CAM.

RESULTS:

Data was collected from 133 patients (response rate: 52%). Of those, 53% had used CAM (mostly classical homeopathy) and 25% of patients received information about CAM from medical staff. Those diagnosed more recently were more likely to be informed about CAM options. The most frequent reason for choosing CAM was that parents thought it would improve the patient’s general condition. The most frequent reason for not using CAM was lack of information. Of those who used CAM, 87% perceived positive effects.

CONCLUSIONS:

Since many pediatric oncology patients use CAM, patients’ needs should be addressed by open communication between families, treating oncologists and CAM therapists, which will allow parents to make informed and safe choices about using CAM.

_______________________________________________________________________________________

Any hope that this paper might back up the statements made by Wurster is thus disappointed.

Altogether, this Wurster-paper contains no reliable evidence. The only clinical trial it seems to rely on is the one by Prof Frass which we have discussed previously here and here. The Frass-study is odd in several ways and, before we can take its results seriously, we need to see an independent replication of its findings. In this context, it is noteworthy that my own 2006 systematic review concluded that there is insufficient evidence to support clinical efficacy of homeopathic therapy in cancer care. In view of all this, I feel that the new Wurster-paper provides no reliable evidence and no reason to change my now somewhat dated conclusion of 2006. Moreover, I would insist that those who claim otherwise are unethical and behave irresponsible.

And finally, I need to reiterate what I stated in my previous post: the Wurster-paper indicates that something is amiss with medical publishing. How can it be that, in 2018, the ‘Deutsche Zeitschrift für Onkologie’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? The editors of this journal (Univ.-Prof. Dr. med. Arndt Büssing, Witten/Herdecke; Dr. med. Peter Holzhauer, Bad Trissl und München) and its editorial board members (L. Auerbach, Wien; C. Bahne Bahnson, Kiel; J. Büntzel, Nordhausen; B. Freimüller-Kreutzer, Heidelberg; H.R. Maurer, Berlin; A. Mayr, Starnberg; R. Moss, New York; T. Ostermann, Witten/Herdecke; K. Prasad, Denver; G. Pulverer, Köln; H. Renner, Nürnberg; C.P. Siegers, Lübeck; W. Schmidt, Greifswald; G. Uhlenbruck, Köln; B. Wolf, München; K.S. Zänker, Witten/Herdecke) should ask themselves whether they are taking their moral obligations seriously enough, or whether their behaviour is not a violation of their most fundamental ethical duties.

In our book ‘MORE HARM THAN GOOD‘ we allude to such problems as follows: …Spurious results are frequently paraded by CAM advocates in support of implausible treatments… the more poorly conceived and executed a research project is, the more likely it is to produce false-positive results. These results then may lead to repetitive cycles of unproductive work to explain what was found—often to simply disprove the erroneous results. This is an unfortunate feature of various fields of scientific research, but it has particularly serious implications in medical research. Moreover, researchers who practice and behave as advocates of CAM may unintentionally or deliberately distort or exaggerate weak findings. Invalid CAM research claims tend not to be put to rest; instead they are repeatedly recycled…

And:

The CAM practitioner who promotes untruths has either failed to enlighten themselves as to the facts—this being a central requirement of professional ethics— or has chosen to deliberately deceive patients. Either of these reasons for promulgating falsehoods amounts to a serious breach in terms of virtue ethics. According to almost all forms of ethical theory, the truth-violating nature of CAM renders it immoral in both theory and practice.

The damage that can result from such violations of medical ethics is not merely a matter for the ‘ivory towers of academia’, it can virtually be a matter of life and death.

The two German authors start their article (it is in German but has an English abstract to which I refer here) by claiming that “homeopathy is steadily gaining in sympathy in the population.” This is a very odd statement, considering that the sales figures in Germany and elsewhere have, in fact, been declining. Any homeopathy-paper with such an opening is naturally of interest to me.

As I read on, I find further surprises: “the possible effectiveness and the modes of action are currently not scientifically elucidated.” These are two big assumptions which happen to be both untrue:

  1. The effectiveness of homeopathy has now been tested in about 500 clinical trials, and the totality of the reliable evidence from these studies fails to show that highly diluted homeopathic remedies are more than placebos.
  2. The mode of action of homeopathy isn’t “not scientifically elucidated“, but the relevant science tells us that there cannot be a mode of action that is in line with the laws of nature as we understand them today.

And the surprises keep on coming: “there is a whole series of positive evidence for the effects of homeopathic remedies for mental disorders, such as depression, anxiety disorders and addiction.” This statement is not in keeping with the results of a systematic review (which, by the way was authored by ardent homeopaths); here is the abstract:

_________________________________________________________________________________________

OBJECTIVE:

To systematically review placebo-controlled randomized trials of homeopathy for psychiatric conditions.

DATA SOURCES:

Eligible studies were identified using the following databases from database inception to April 2010: PubMed, CINAHL, PsycINFO, Hom-Inform, Cochrane CENTRAL, National Center for Complementary and Alternative Medicine grantee publications database, and ClinicalTrials.gov. Gray literature was also searched using Google, Google Scholar, the European Committee for Homeopathy, inquiries with homeopathic experts and manufacturers, and the bibliographic lists of included published studies and reviews. Search terms were as follows: (homeopath* or homoeopath*) and (placebo or sham) and (anxiety or panic or phobia or post-traumatic stress or PTSD or obsessive-compulsive disorder or fear or depress* or dysthym* or attention deficit hyperactivity or premenstrual syndrome or premenstrual disorder or premenstrual dysphoric disorder or traumatic brain injury or fibromyalgia or chronic fatigue syndrome or myalgic encephalitis or insomnia or sleep disturbance). Searches included only English-language literature that reported randomized controlled trials in humans.

STUDY SELECTION:

Trials were included if they met 7 criteria and were assessed for possible bias using the Scottish Intercollegiate Guidelines Network (SIGN) 50 guidelines. Overall assessments were made using the Grading of Recommendations Assessment, Development and Evaluation procedure. Identified studies were grouped into anxiety or stress, sleep or circadian rhythm complaints, premenstrual problems, attention-deficit/hyperactivity disorder, mild traumatic brain injury, and functional somatic syndromes.

RESULTS:

Twenty-five eligible studies were identified from an initial pool of 1,431. Study quality according to SIGN 50 criteria varied, with 6 assessed as good, 9 as fair, and 10 as poor. Outcome was unrelated to SIGN quality. Effect size could be calculated in 16 studies, and number needed to treat, in 10 studies. Efficacy was found for the functional somatic syndromes group (fibromyalgia and chronic fatigue syndrome), but not for anxiety or stress. For other disorders, homeopathy produced mixed effects. No placebo-controlled studies of depression were identified. Meaningful safety data were lacking in the reports, but the superficial findings suggested good tolerability of homeopathy. A funnel plot in 13 studies did not support publication bias (χ(2)(1) = 1.923, P = .166).

CONCLUSIONS:

The database on studies of homeopathy and placebo in psychiatry is very limited, but results do not preclude the possibility of some benefit.

___________________________________________________________________________________

And specifically for depression, another review (also by proponents of homeopathy) is available; here is its abstract:

OBJECTIVE:

To systematically review the research evidence on the effectiveness of homeopathy for the treatment of depression and depressive disorders.

METHODS:

A comprehensive search of major biomedical databases including MEDLINE, EMBASE, CINAHL, PsycINFO and the Cochrane Library was conducted. Specialist complementary and alternative medicine (CAM) databases including AMED, CISCOM and Hom-Inform were also searched. Additionally, efforts were made to identify unpublished and ongoing research using relevant sources and experts in the field. Relevant research was categorised by study type and appraised according to study design. Clinical commentaries were obtained for studies reporting clinical outcomes.

RESULTS:

Only two randomised controlled trials (RCTs) were identified. One of these, a feasibility study, demonstrated problems with recruitment of patients in primary care. Several uncontrolled and observational studies have reported positive results including high levels of patient satisfaction but because of the lack of a control group, it is difficult to assess the extent to which any response is due to specific effects of homeopathy. Single-case reports/studies were the most frequently encountered clinical study type. We also found surveys, but no relevant qualitative research studies were located.: Adverse effects reported appear limited to ‘remedy reactions’ (‘aggravations’) including temporary worsening of symptoms, symptom shifts and reappearance of old symptoms. These remedy reactions were generally transient but in one study, aggravation of symptoms caused withdrawal of the treatment in one patient.

CONCLUSIONS:

A comprehensive search for published and unpublished studies has demonstrated that the evidence for the effectiveness of homeopathy in depression is limited due to lack of clinical trials of high quality. Further research is required, and should include well-designed controlled studies with sufficient numbers of participants. Qualitative studies aimed at overcoming recruitment and other problems should precede further RCTs. Methodological options include the incorporation of preference arms or uncontrolled observational studies. The highly individualised nature of much homeopathic treatment and the specificity of response may require innovative methods of analysis of individual treatment response.

____________________________________________________________________________________

Back to the new article I started discussing above. Its authors make a vague attempt at being reasonable: “It is clear that homoeopathic remedies can only be used as an add-on and not alone.” I find this statement slightly puzzling. If (as the authors assume) homeopathy is effective for mental disorders, why not on its own? Can a therapy that must not be used as a sole treatment be called effective?

The authors continue with another caveat:  “These remedies belong in the hands of physicians experienced in homeopathic and psychiatric psychopharmacology.” That’s actually quite funny! As the average homeopath has no experience in psychiatric psychopharmacology, they must not use homeopathy for mental conditions. I would agree with the conclusion but not with the reason given for it.

And now to the ‘grand finale’, the conclusion: “It would be advisable to at least try out homeopathy for the well-being of the patient not only in the case of very mild disorders but also in severe chronic cases, since due to the generally good tolerability, no avoidable disadvantage should result.” That sort of conclusion makes me almost speechless. The evidence fails to show that it works, yet it is ADVISABLE to use it in severe chronic cases!

Such articles suggest to me that homeopathy is a cult where logic and reason are irrelevant and need to be supressed. They also indicate that something is amiss with medical publishing. How can it be that, in 2018, ‘Der Nervenarzt’ (or any other medical journal for that matter) can be so bar of critical thinking to publish such dangerously misleading nonsense? ‘Der Nervenarzt‘, by the way, claims to be an internationally recognized journal addressing neurologists and psychiatrists working in clinical or practical environments. Essential findings and current information from neurology, psychiatry as well as neuropathology, neurosurgery up to psychotherapy are presented.

An article entitled “Homeopathy in the Age of Antimicrobial Resistance: Is It a Viable Treatment for Upper Respiratory Tract Infections?” cannot possibly be ignored on this blog, particularly if published in the amazing journal ‘Homeopathy‘. The title does not bode well, in my view – but let’s see. Below, I copy the abstract of the paper without any changes; all I have done is include a few numbers in brackets; they refer to my comments that follow.

START OF ABSTRACT

Acute upper respiratory tract infections (URTIs) and their complications are the most frequent cause of antibiotic prescribing in primary care. With multi-resistant organisms proliferating, appropriate alternative treatments to these conditions are urgently required. Homeopathy presents one solution (1); however, there are many methods of homeopathic prescribing. This review of the literature considers firstly whether homeopathy offers a viable alternative therapeutic solution for acute URTIs (2) and their complications, and secondly how such homeopathic intervention might take place.

METHOD:

Critical review of post 1994 (3) clinical studies featuring homeopathic treatment of acute URTIs and their complications. Study design, treatment intervention, cohort group, measurement and outcome were considered. Discussion focused on the extent to which homeopathy is used to treat URTIs, rate of improvement and tolerability of the treatment, complications of URTIs, prophylactic and long-term effects, and the use of combination versus single homeopathic remedies.

RESULTS:

Multiple peer-reviewed (4) studies were found in which homeopathy had been used to treat URTIs and associated symptoms (cough, pharyngitis, tonsillitis, otitis media, acute sinusitis, etc.). Nine randomised controlled trials (RCTs) and 8 observational/cohort studies were analysed, 7 of which were paediatric studies. Seven RCTs used combination remedies with multiple constituents. Results for homeopathy treatment were positive overall (5), with faster resolution, reduced use of antibiotics and possible prophylactic and longer-term benefits.

CONCLUSIONS:

Variations in size, location, cohort and outcome measures make comparisons and generalisations concerning homeopathic clinical trials for URTIs problematic (6). Nevertheless, study findings suggest at least equivalence between homeopathy and conventional treatment for uncomplicated URTI cases (7), with fewer adverse events and potentially broader therapeutic outcomes. The use of non-individualised homeopathic compounds tailored for the paediatric population merits further investigation, including through cohort studies (8). In the light of antimicrobial resistance, homeopathy offers alternative strategies for minor infections and possible prevention of recurring URTIs (9).

END OF ABSTRACT

And here are my comments:

  1. This sounds as though the author already knew the conclusion of her review before she even started.
  2. Did she not just state that homeopathy is a solution?
  3. This is most unusual; why were pre-1994 articles not considered?
  4. This too is unusual; that a study is peer-reviewed is not really possible to affirm, one must take the journal’s word for it. Yet we know that peer-review is farcical in the realm of alternative medicine (see also below). Therefore, this is an odd inclusion criterion to mention in an abstract.
  5. An overall positive result obtained by including uncontrolled observational and cohort studies lacking a control group is meaningless. There is also no assessment of the quality of the RCTs; after a quick glance, I get the impression that the methodologically sound studies do not show homeopathy to be superior to placebo.
  6. Reviewers need to disentangle these complicating factors and arrive at a conclusion. This is almost invariably problematic, but it is the reviewer’s job.
  7. What might be the conventional treatment of uncomplicated URTI?
  8. Why on earth cohort studies? They tell us nothing about equivalence, efficacy etc.
  9. To reach that conclusion seems to have been the aim of this review (see my point number 1). If I am not mistaken, antibiotics are not indicated in the vast majority of cases of uncomplicated URTI. This means that the true alternative in the light of antimicrobial resistance is to not prescribe antibiotics and treat the patient symptomatically. No need at all for homeopathic placebos, and no need for wishful thinking reviews!

In the paper, the author explains her liking of uncontrolled studies: Non-RCTs and patient reported surveys are considered by some to be inferior forms of research evidence, but are important adjuncts to RCTs that can measure key markers such as patient satisfaction, quality of life and functional health. Observational studies such as clinical outcome studies and case reports, monitoring the effects of homeopathy in real-life clinical settings, are a helpful adjunct to RCTs and more closely reflect real-life experiences of patients and physicians than RCTs, and are therefore considered in this study. I would counter that this is not an issue of inferiority but one that depends on the research question; if the research question relates to efficacy/effectiveness, uncontrolled data are next to useless.

She also makes fairly categorical statements in the conclusion section of the paper about the effectiveness of homeopathy: [the] combined evidence from these and other studies suggests that homeopathic treatment can exert biological effects with fewer adverse events and broader therapeutic opportunities than conventional medicine in the treatment of URTIs. Given the cost implications of treating URTIs and their complications in children, and the relative absence of effective alternatives without potential side effects, the use of non-individualised homeopathic compounds tailored for the paediatric population merits further investigation, including through large-scale cohort studies…  the most important evidence still arises from practical clinical experience and from the successful treatment of millions of patients. I would counter that none of these conclusions are warranted by the data presented.

From reading the paper, I get the impression that the author (the paper provides no information about her conflicts of interest, nor funding source) is a novice to conducting reviews (even though the author is a senior lecturer, the paper reads more like a poorly organised essay than a scientific review). I am therefore hesitant to criticise her – but I do nevertheless find the fact deplorable that her article passed the peer-review process of ‘Homeopathy‘ and was published in a seemingly respectable journal. If anything, articles of this nature are counter-productive for everyone concerned; they certainly do not further effective patient care, and they give homeopathy-research a worse name than it already has.

Alternative practitioners practise highly diverse therapies. They seem to have nothing in common – except perhaps that ALL of them are allegedly stimulating our self-healing powers (and except that most proponents are latently or openly against vaccinations). And it is through these self-healing powers that the treatments in question cure anything and become a true panacea. When questioned what these incredible powers really are, most practitioners would (somewhat vaguely) name the immune system as the responsible mechanism. With this post, I intend to provide a short summary of the evidence on this issue:

Acupuncture: no good evidence to show stimulation of self-healing powers.

Aromatherapy: no good evidence to show stimulation of self-healing powers.

Bioresonance: no good evidence to show stimulation of self-healing powers.

Chiropractic: no good evidence to show stimulation of self-healing powers.

Detox: no good evidence to show stimulation of self-healing powers.

Energy healing: no good evidence to show stimulation of self-healing powers.

Feldenkrais: no good evidence to show stimulation of self-healing powers.

Gua sha: no good evidence to show stimulation of self-healing powers.

Herbal medicine: no good evidence to show stimulation of self-healing powers.

Homeopathy: no good evidence to show stimulation of self-healing powers.

Macrobiotics: no good evidence to show stimulation of self-healing powers.

Naturopathy: no good evidence to show stimulation of self-healing powers.

Osteopathy: no good evidence to show stimulation of self-healing powers.

Power bands: no good evidence to show stimulation of self-healing powers.

Reiki: no good evidence to show stimulation of self-healing powers.

Reflexology: no good evidence to show stimulation of self-healing powers.

Shiatsu: no good evidence to show stimulation of self-healing powers.

Tai chi: no good evidence to show stimulation of self-healing powers.

TCM: no good evidence to show stimulation of self-healing powers.

Vibrational therapy: no good evidence to show stimulation of self-healing powers.


Vaccinations: very good evidence to show stimulation of self-healing powers.


THE END

Several previous studies have suggested improvements in sperm quality after vitamin supplementation, and several reviews have drawn tentatively positive conclusions:

Most of the primary trials lacked scientific rigour, however. Now a new study has emerged that overcomes many of the flaws of the previous research.

Professor Anne Steiner from the University of North Carolina at Chapel Hill, USA, presented her study yesterday at the 34th Annual Meeting of ESHRE in Barcelona. This clinical trial of 174 couples has found that an antioxidant formulation taken daily by the male partner for a minimum of three months made no difference to sperm concentration, motility or morphology, nor to the rate of DNA fragmentation. The study was performed in eight American fertility centres.

All men in the study had been diagnosed with male factor infertility, reflected in subnormal levels of sperm concentration, motility, or morphology, or higher than normal rates of DNA fragmentation. These parameters were measured at the start of the trial and at three months. In between, the men allocated to the antioxidant intervention were given a daily supplement containing vitamins C, D3 and E, folic acid, zinc, selenium and L-carnitine; the control group received a placebo.

At three months, results showed only a “slight” overall difference in sperm concentration between the two groups, and no significant differences in morphology, motility, or DNA fragmentation measurements. Sub-group analysis (according to different types of sperm abnormality) found no significant differences in sperm concentration (in oligospermic men), motility (in asthenospermic men), and morphology (in teratospermic men).(1) There was also no change seen after three months in men with high rates of DNA fragmentation (28.9% in the antioxidant group and 28.8 in the placebo group).

Natural conception during the initial three month study period did also not differ between the two groups of the entire cohort – a pregnancy rate of 10.5% in the antioxidant group and 9.1% in the placebo. These rates were also comparable at six months (after continued antioxidant or placebo for the male partner and three cycles of clomiphene and intrauterine insemination for the female partner).

The authors concluded that “the results do not support the empiric use of antioxidant therapy for male factor infertility in couples trying to conceive naturally”.

The story about supplements and health claims seems to be strangely repetitive:

  • the claim that supplements help for condition xy is heavily promoted, e. g. via the Internet;
  • a few flimsy trials seem to support the claim;
  • these results are relentlessly hyped;
  • the profit of the manufacturers grows;
  • eventually a rigorous, independently-funded trial emerges with a negative finding;
  • the card house seems to collapse;
  • the manufacturers claim that the trial’s methodology was faulty (e. g. wrong does, wrong mixture of ingredients);
  • thus another profitable card house is built elsewhere.

In the end, the only supplement-related effects are that 1) the consumers produce expensive urine and 2) the manufacturers have plenty of funds to start a new campaign based on yet another bogus heath claim.

One of the biggest danger of SCAM, in my view, is the fact that SCAM-practitioners all too often advise their patients to forego effective conventional medicine. This probably applies to most medicines, but is best-researched for immunisations. A recent article puts it clearly:

… negative attitudes towards vaccines reflect a broader and deeper set of beliefs about health and wellbeing… this alternative worldview is influenced by ontological confusions (e.g. regarding purity, natural energy), and knowledge based on personal lived experience and trusted peers, rather than the positivist epistemological framework. [This] view is supported by recent social-psychological research, including strong correlations of vaccine scepticism with adherence to complementary and alternative medicine, magical health beliefs, and conspiracy ideation. For certain well-educated and well-resourced individuals, opposition to vaccines represents an expression of personal intuition and agency, in achieving a positive and life-affirming approach to health and wellbeing. These core beliefs are not amenable to change – and especially resistant to communications from orthodox, authoritative sources.

The authors concluded suggesting that a better long-term strategy is to combine with other disciplines in order to address the root causes of vaccine scepticism. Vaccine scepticism is unlikely to thrive in a cultural context that trusts and values the scientific consensus.

If I understand them correctly, the authors believe it is necessary to change the societal attitude to science.

I am sure they are correct.

We live in a time when anyone’s opinion is deemed as valuable as the next person’s. Pseudo-experts who have their knowledge from a couple of google searches are being considered as trustworthy as the true experts who have the background, knowledge and experience to issue responsible advice. Science is viewed by many as just another way of knowing, or even as the new cult or religion that must be viewed with suspicion.

It is clear that these are deplorable developments. But how to stop them?

This is where it gets complex.

One is tempted to lay the blame at the door of our politicians. Why do we tolerate the fact that so many of them have not the slightest inkling about science?

But hold on, WE elected them!

Why?

Because large sections of the public are ignorant too.

So, one must start much earlier. We need better science education, and that has to begin in the first year of schooling! We need evening classes in critical thinking. We need adult science courses for politicians.

But this is not going to happen, because our politicians fail to see the importance of such measures (and, of course, they might feel that an uneducated public is easier to govern than an educated one).

How to break this vicious circle?

It is clear from these simple (and simplistic) reflections that a multifactorial approach is required. And it is clear that it ought to be a strategy that prevents standards in the most general terms from slipping ever lower. But how?

I wish I knew!!!

The only time we discussed gua sha, it led to one of the most prolonged discussions we ever had on this blog (536 comments so far). It seems to be a topic that excites many. But what precisely is it?

Gua sha, sometimes referred to as “scraping”, “spooning” or “coining”, is a traditional Chinese treatment that has spread to several other Asian countries. It has long been popular in Vietnam and is now also becoming well-known in the West. The treatment consists of scraping the skin with a smooth edge placed against the pre-oiled skin surface, pressed down firmly, and then moved downwards along muscles or meridians. According to its proponents, gua sha stimulates the flow of the vital energy ‘chi’ and releases unhealthy bodily matter from blood stasis within sore, tired, stiff or injured muscle areas.

The technique is practised by TCM practitioners, acupuncturists, massage therapists, physical therapists, physicians and nurses. Practitioners claim that it stimulates blood flow to the treated areas, thus promoting cell metabolism, regeneration and healing. They also assume that it has anti-inflammatory effects and stimulates the immune system.

These effects are said to last for days or weeks after a single treatment. The treatment causes microvascular injuries which are visible as subcutaneous bleeding and redness. Gua sha practitioners make far-reaching therapeutic claims, including that the therapy alleviates pain, prevents infections, treats asthma, detoxifies the body, cures liver problems, reduces stress, and contributes to overall health.

Gua sha is mildly painful, almost invariably leads to unsightly blemishes on the skin which occasionally can become infected and might even be mistaken for physical abuse.

There is little research of gua sha, and the few trials that exist tend to be published in Chinese. But recently, a new paper has emerged that is written in English. The goal of this systematic review was to evaluate the available evidence from randomized controlled trials (RCTs) of gua sha for the treatment of patients with perimenopausal syndrome.

A total of 6 RCTs met the inclusion criteria. Most were of low methodological quality. When compared with Western medicine therapy alone, meta-analysis of 5 RCTs indicated favorable statistically significant effects of gua sha plus Western medicine. Moreover, study participants who received Gua Sha therapy plus Western medicine therapy showed significantly greater improvements in serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH) compared to participants in the Western medicine therapy group.

The authors concluded that preliminary evidence supported the hypothesis that Gua Sha therapy effectively improved the treatment efficacy in patients with perimenopausal syndrome. Additional studies will be required to elucidate optimal frequency and dosage of Gua Sha.

This sounds as though gua sha is a reasonable therapy.

Yet, I think this notion is worth being critically analysed. Here are some caveats that spring into my mind:

  • Gua sha lacks biological plausibility.
  • The reviewed trials are too flawed to allow any firm conclusions.
  • As most are published in Chinese, non-Chinese speakers have no possibility to evaluate them.
  • The studies originate from China where close to 100% of TCM trials report positive results.
  • In my view, this means they are less than trustworthy.
  • The authors of the above-cited review are all from China and might not be willing, able or allowed to publish a critical paper on this subject.
  • The review was published in , a journal not known for its high scientific standards or critical stance towards TCM.

So, is gua sha a reasonable therapy?

I let you make this judgement.

Is homeopathy effective for specific conditions? The FACULTY OF HOMEOPATHY (FoH, the professional organisation of UK doctor homeopaths) say YES. In support of this bold statement, they cite a total of 35 systematic reviews of homeopathy with a focus on specific clinical areas. “Nine of these 35 reviews presented conclusions that were positive for homeopathy”, they claim. Here they are:

Allergies and upper respiratory tract infections 8,9
Childhood diarrhoea 10
Post-operative ileus 11
Rheumatic diseases 12
Seasonal allergic rhinitis (hay fever) 13–15
Vertigo 16

And here are the references (I took the liberty of adding my comments in blod):

8. Bornhöft G, Wolf U, Ammon K, et al. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – summarized health technology assessment. Forschende Komplementärmedizin, 2006; 13 Suppl 2: 19–29.

This is the infamous ‘Swiss report‘ which, nowadays, only homeopaths take seriously.

9. Bellavite P, Ortolani R, Pontarollo F, et al. Immunology and homeopathy. 4. Clinical studies – Part 1. Evidence-based Complementary and Alternative Medicine: eCAM, 2006; 3: 293–301.

This is not a systematic review as it lacks any critical assessment of the primary data and includes observational studies and even case series.

10. Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediatric Infectious Disease Journal, 2003; 22: 229–234.

This is a meta-analysis by Jennifer Jacobs (who recently featured on this blog) of 3 studies by Jennifer Jacobs; hardly convincing I’d say.

11. Barnes J, Resch K-L, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. Journal of Clinical Gastroenterology, 1997; 25: 628–633.

This is my own paper! It concluded that “several caveats preclude a definitive judgment.”

12. Jonas WB, Linde K, Ramirez G. Homeopathy and rheumatic disease. Rheumatic Disease Clinics of North America, 2000; 26: 117–123.

This is not a systematic review; here is the (unabridged) abstract:

Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide.

Proper systematic reviews fail to show that homeopathy is an effective treatment for rheumatic conditions (see for instance here and here).

13. Wiesenauer M, Lüdtke R. A meta-analysis of the homeopathic treatment of pollinosis with Galphimia glauca. Forschende Komplementärmedizin und Klassische Naturheilkunde, 1996; 3: 230–236.

This is a meta-analysis by Wiesenauer of trials conducted by Wiesenauer.

My own, more recent analysis of these data arrived at a considerably less favourable conclusion: “… three of the four currently available placebo-controlled RCTs of homeopathic Galphimia glauca (GG) suggest this therapy is an effective symptomatic treatment for hay fever. There are, however, important caveats. Most essentially, independent replication would be required before GG can be considered for the routine treatment of hay fever. (Focus on Alternative and Complementary Therapies September 2011 16(3))

14. Taylor MA, Reilly D, Llewellyn-Jones RH, et al. Randomised controlled trials of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. British Medical Journal, 2000; 321: 471–476.

This is a meta-analysis by David Reilly of 4 RCTs which were all conducted by David Reilly. This attracted heavy criticism; see here and here, for instance.

15. Bellavite P, Ortolani R, Pontarollo F, et al. Immunology and homeopathy. 4. Clinical studies – Part 2. Evidence-based Complementary and Alternative Medicine: eCAM, 2006; 3: 397–409.

This is not a systematic review as it lacks any critical assessment of the primary data and includes observational studies and even case series.

16. Schneider B, Klein P, Weiser M. Treatment of vertigo with a homeopathic complex remedy compared with usual treatments: a meta-analysis of clinical trials. Arzneimittelforschung, 2005; 55: 23–29.

This is a meta-analysis of 2 (!) RCTs and 2 observational studies of ‘Vertigoheel’, a preparation which is not a homeopathic but a homotoxicologic remedy (it does not follow the ‘like cures like’ assumption of homeopathy) . Moreover, this product contains pharmacologically active substances (and nobody doubts that active substances can have effects).

________________________________________________________________________________

So, positive evidence from 9 systematic reviews in 6 specific clinical areas?

I let you answer this question.

Shiatsu is an alternative therapy that is popular, but has so far attracted almost no research. Therefore, I was excited when I saw a new paper on the subject. Sadly, my excitement waned quickly when I stared reading the abstract.

This single-blind randomized controlled study was aimed to evaluate shiatsu on mood, cognition, and functional independence in patients undergoing physical activity. Alzheimer disease (AD) patients with depression were randomly assigned to the “active group” (Shiatsu + physical activity) or the “control group” (physical activity alone).

Shiatsu was performed by the same therapist once a week for ten months. Global cognitive functioning (Mini Mental State Examination – MMSE), depressive symptoms (Geriatric Depression Scale – GDS), and functional status (Activity of Daily Living – ADL, Instrumental ADL – IADL) were assessed before and after the intervention.

The researchers found a within-group improvement of MMSE, ADL, and GDS in the Shiatsu group. However, the analysis of differences before and after the interventions showed a statistically significant decrease of GDS score only in the Shiatsu group.

The authors concluded that the combination of Shiatsu and physical activity improved depression in AD patients compared to physical activity alone. The pathomechanism might involve neuroendocrine-mediated effects of Shiatsu on neural circuits implicated in mood and affect regulation.

The Journal Complementary Therapies in Medicine also published three ‘Highlights’ of this study:

  • We first evaluated the effect of Shiatsu in depressed patients with Alzheimer’s disease (AD).
  • Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients.
  • Neuroendocrine-mediated effect of Shiatsu may modulate mood and affect neural circuits.

Where to begin?

1 The study is called a ‘pilot’. As such it should not draw conclusions about the effectiveness of Shiatsu.

2 The design of the study was such that there was no accounting for the placebo effect (the often-discussed ‘A+B vs B’ design); therefore, it is impossible to attribute the observed outcome to Shiatsu. The ‘highlight’ – Shiatsu significantly reduced depression in a sample of mild-to-moderate AD patients – therefore turns out to be a low-light.

3 As this was a study with a control group, within-group changes are irrelevant and do not even deserve a mention.

4 The last point about the mode of action is pure speculation, and not borne out of the data presented.

5 Accumulating so much nonsense in one research paper is, in my view, unethical.

Research into alternative medicine does not have a good reputation – studies like this one are not inclined to improve it.

The HRI is an innovative international charity created to address the need for high quality scientific research in homeopathy… HRI is dedicated to promoting cutting research in homeopathy, using the most rigorous methods available, and communicating the results of such work beyond the usual academic circles… HRI aims to bring academically reliable information to a wide international audience, in an easy to understand form. This audience includes the general public, scientists, healthcare providers, healthcare policy makers, government and the media.

This sounds absolutely brilliant!

I should be a member of the HRI!

For years, I have pursued similar aims!

Hold on, perhaps not?

This article makes me wonder:

START OF QUOTE

… By the end of 2014, 189 randomised controlled trials of homeopathy on 100 different medical conditions had been published in peer-reviewed journals. Of these, 104 papers were placebo-controlled and were eligible for detailed review:
41% were positive (43 trials) – finding that homeopathy was effective
5% were negative (5 trials) – finding that homeopathy was ineffective
54% were inconclusive (56 trials)

How does this compare with evidence for conventional medicine?

An analysis of 1016 systematic reviews of RCTs of conventional medicine had strikingly similar findings2:
44% were positive – the treatments were likely to be beneficial
7% were negative – the treatments were likely to be harmful
49% were inconclusive – the evidence did not support either benefit or harm.

END OF QUOTE

The implication here is that the evidence base for homeopathy is strikingly similar to that of real medicine.

Nice try! But sadly it has nothing to do with ‘reliable information’!!!

In fact, it is grossly (and I suspect deliberately) misleading.

Regular readers of this blog will have spotted the reason, because we discussed (part of) it before. Let me remind you:

_______________________________________________________________________________

A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null-hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.

For enthusiasts of alternative medicine, this can create a dilemma, particularly if there are lots of published studies with negative results. In this case, the totality of the available trial evidence is negative which means the treatment in question cannot be characterised as effective. It goes without saying that such an overall conclusion rubs the proponents of that therapy the wrong way. Consequently, they might look for ways to avoid this scenario.

One fairly obvious way of achieving this aim is to simply re-categorise the results. What, if we invented a new category? What, if we called some of the negative studies by a different name? What about INCONCLUSIVE?

That would be brilliant, wouldn’t it. We might end up with a simple statistic where the majority of the evidence is, after all, positive. And this, of course, would give the impression that the ineffective treatment in question is effective!

How exactly do we do this? We continue to call positive studies POSITIVE; we then call studies where the experimental treatment generated worst results than the control treatment (usually a placebo) NEGATIVE; and finally we call those studies where the experimental treatment created outcomes which were not different from placebo INCONCLUSIVE.

In the realm of alternative medicine, this ‘non-conclusive result’ method has recently become incredibly popular . Take homeopathy, for instance. The Faculty of Homeopathy proudly claim the following about clinical trials of homeopathy: Up to the end of 2011, there have been 164 peer-reviewed papers reporting randomised controlled trials (RCTs) in homeopathy. This represents research in 89 different medical conditions. Of those 164 RCT papers, 71 (43%) were positive, 9 (6%) negative and 80 (49%) non-conclusive.

This misleading nonsense was, of course, warmly received by homeopaths. The British Homeopathic Association, like many other organisations and individuals with an axe to grind lapped up the message and promptly repeated it: The body of evidence that exists shows that much more investigation is required – 43% of all the randomised controlled trials carried out have been positive, 6% negative and 49% inconclusive.

Let’s be clear what has happened here: the true percentage figures seem to show that 43% of studies (mostly of poor quality) suggest a positive result for homeopathy, while 57% of them (on average the ones of better quality) were negative. In other words, the majority of this evidence is negative. If we conducted a proper systematic review of this body of evidence, we would, of course, have to account for the quality of each study, and in this case we would have to conclude that homeopathy is not supported by sound evidence of effectiveness.

The little trick of applying the ‘INCONCLUSIVE’ method has thus turned this overall result upside down: black has become white! No wonder that it is so popular with proponents of all sorts of bogus treatments.

__________________________________________________________________________________

But one trick is not enough for the HRI! For thoroughly misinforming the public they have a second one up their sleeve.

And that is ‘comparing apples with pears’  – RCTs with systematic reviews, in their case.

In contrast to RCTs, systematic reviews can be (and often are) INCONCLUSIVE. As they evaluate the totality of all RCTs on a given subject, it is possible that some RCTs are positive, while others are negative. When, for example, the number of high-quality, positive studies included in a systematic review is similar to the number of high-quality, negative trials, the overall result of that review would be INCONCLUSIVE. And this is one of the reasons why the findings of systematic reviews cannot be compared in this way to those of RCTs.

I suspect that the people at the HRI know all this. They are not daft! In fact, they are quite clever. But unfortunately, they seem to employ their cleverness not for informing but for misleading their ‘wide international audience’.

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