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

scientific misconduct

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About 85% of German children are treated with herbal remedies. Yet, little is known about the effects of such interventions. A new study might tell us more.

This analysis accessed 2063 datasets from the paediatric population in the PhytoVIS data base, screening for information on indication, gender, treatment, co-medication and tolerability. The results suggest that the majority of patients was treated with herbal medicine for the following conditions:

  • common cold,
  • fever,
  • digestive complaints,
  • skin diseases,
  • sleep disturbances
  • anxiety.

The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events.

The authors concluded that the results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.

If you are a fan of herbal medicine, you will be jubilant. If, on the other hand, you are a critical thinker or a responsible healthcare professional, you might wonder what this database is, why it was set up and how exactly these findings were produced. Here are some details:

The data were collected by means of a retrospective, anonymous, one-off survey consisting of 20 questions on the user’s experience with herbal remedies. The questions included complaints/ disease, information on drug use, concomitant factors/diseases as well as basic patient data. Trained interviewers performed the interviews in pharmacies and doctor’s offices. Data were collected in the Western Part of Germany between April 2014 and December 2016. The only inclusion criterion was the intake of herbal drugs in the last 8 weeks before the individual interview. The primary endpoint was the effect and tolerability of the products according to the user.

And who participated in this survey? If I understand it correctly, the survey is based on a convenience sample of parents using herbal remedies. This means that those parents who had a positive experience tended to volunteer, while those with a negative experience were absent or tended to refuse. (Thus the survey is not far from the scenario I often use where people in a hamburger restaurant are questioned whether they like hamburgers.)

So, there are two very obvious factors other than the effectiveness of herbal remedies determining the results:

  1. selection bias,
  2. lack of objective outcome measure.

This means that conclusions about the clinical effects of herbal remedies in paediatric patients are quite simply not possible on the basis of this survey. So, why do the authors nevertheless draw such conclusions (without a critical discussion of the limitations of their survey)?

Could it have something to do with the sponsor of the research?

The PhytoVIS study was funded by the Kooperation Phytopharmaka GbR Bonn, Germany.

Or could it have something to do with the affiliations of the paper’s authors:

1 Institute of Pharmacy, University of Leipzig, Brüderstr. 34, 04103, Leipzig, Germny. nieberkaren@gmx.de.

2 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 573, Bonn, Germany. nieberkaren@gmx.de.

3 Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

4 ClinNovis GmbH, Genter Str. 7, 50672, Cologne, Germany.

5 Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany.

6 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 53173, Bonn, Germany.

7 Institute of Pharmaceutical Biology, Goethe University Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt, Germany.

8 Chair of Naturopathy, University Medicine Rostock, Ernst-Heydemann Str. 6, 18057, Rostock, Germany.

WHAT DO YOU THINK?

An enthusiast of homeopathy recently posted an overview of systematic reviews of homeopathy concluding that the data we do have point towards homeopathy as having an effect greater than that of placebo:

In recent decades, homeopathy has been examined via a number of clinical trials, the number of which now allow meta-analysis. As we can see from the study findings, the type of homeopathy research (ie, individualized vs non-individualized, placebo-controlled vs non-placebo-controlled) can have a strong influence on the results, although trial quality also has a strong effect.

All meta-analyses performed in at least a somewhat open and rigorous manner have found statistically significant effects. This suggests that homeopathy has a greater-than-placebo effect, or at least a strong trend in that direction, when using data from the totality of homeopathy research, or from individualized, placebo-controlled trials. The meta-analyses with questionable methodology, one of which is undergoing government investigation for academic irregularities, have produced negative results, which have been demonstrated to be a direct result of their exclusion of vast swathes of the homeopathic clinical trial literature (based on arbitrary and unexplained criteria), as well as of their failure to differentiate – as Mathie has done – different types of homeopathic research.

The clinical data are flawed. Issues with methodology used in homeopathy RCTs, combined with a lack of research funding, have produced a lack of high-quality trials and data. However, the data we do have point towards homeopathy as having an effect greater than that of placebo.

There can be no argument with this conclusion, aside from possible new data emerging. Anyone who disputes this is going against the existing set of the highest-quality evidence on homeopathy.

His overview is based on the following publications:

Kleijnen, 19911 All types of homeopathy (eg, single remedy vs combination). Methodological quality assessed; 105 trials. Results: Positive trend, regardless of type of homeopathy; 81 trials were positive, 24 showed no effect.
Linde, 19972 All types of homeopathy. Out of 185 trials, 119 met inclusion criteria; 89 of these had extractable data. Results: OR = 2.45 (95% CI 2.05-2.93).
Ernst, 19983 Individualized homeopathy; 5 trials determined to be high-quality. Results: OR = 0.
Linde, 19985 Individualized homeopathy; 32 trials, 19 of which had extractable data. Results: OR = 1.62 for all trials (95% CI 1.17-2.23). Only high-quality trials produced no significant trend.
Cucherat, 20009 All types of homeopathy; 118 trials, 16 of which met inclusion criteria. Used unusual method of combining p values. Results: All trials = p< 0.000036. Less than 10% dropouts: p<0.084; less than 5% dropouts (higher standards than most trials considered reliable): p<0.08 (non-significant).
Shang, 200511 All types of homeopathy; only 8 trials selected from 21 high-quality trials of 110 selected with unusual criteria. Results: OR = 0.88 (0.65-1.19). Result strongly disputed by statisticians.
Mathie, 201413 Individualized homeopathy; of the analysis pooled data from 22 higher-quality, individualized, double-blind RCTs. Results: OR = 1.53 (1.22-1.91) for all trials pooled; OR = 1.93 (1.16-3.38) for the 3 reliable trials.
NHMRC, 201516 Out of 176 studies, 171 were excluded, leaving only 5 for the study. Investigators used unprecedented methods, did not combine data, and are currently under investigation for outcome shopping. Results: Negative results.
Mathie, 201720 Non-individualized homeopathy; very few higher-quality trials. Results: For 54 trials with extractable data, SMD = -0.33 (-0.44, -0.21). When these were adjusted for publication bias, SMD = -0.16 (-0.46,-0.09). The 3 high-quality trials had non-significant results: SMD = -0.18 (-0.46, +0.09).
Mathie, 201821 Individualized, other-than-placebo-controlled trials; 11 trials found, 8 with extractable data. Results: 4 heterogeneous comparative trials showed a non-significant difference. One trial in this group was positive. Three heterogeneous trials with additive homeopathy showed a statistically significant SMD. No definitive conclusion possible due to trial heterogeneity, poor quality, and low number of trials.
Mathie, 201922 Non-individualized, other-than-placebo-controlled trials; 17 RCTs found, 14 with high risk of bias. Results: Significant heterogeneity prevented much comparison; 3 comparable trials showed a non-significant SMD.

Apart from getting the wrong end of the stick when interpreting the results of these papers (see for instance here, and here), there are other rather embarrassing flaws in this overview:

  1. Many older systematic reviews were omitted (including about 10 of my own papers). This is relevant because the author of the above review went beck until 1991 to find the reviews he included.
  2. Several new papers were missing as well. This is relevant because the author evidently included reviews up to 2019. Here are the key passages from the conclusions of some of them:

homoeopathy as a whole may be considered as a placebo treatment.

We tested whether p-curve accurately rejects the evidential value of significant results obtained in placebo-controlled clinical trials of homeopathic ultramolecular dilutions. Our results suggest that p-curve can accurately detect when sets of statistically significant results lack evidential value.

We found no evidence to support the efficacy of homeopathic medicinal products

no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn.

Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive.

… the use of homeopathy currently cannot claim to have sufficient prognostic validity where efficacy is concerned.

I am, of course, not saying that this overview amounts to anything like a systematic review. It merely gives you a flavour how trustworthy proponents of homeopathy are when they pretend to provide us with an objective evaluation of the best available evidence.

A 2020 review entitled ‘Prevention, Treatment and Management of Tuberculosis through Combinational Approaches of Different Indian Systems of Medicine’ stated that recent research suggests that Homeopathic treatment along with the antibiotics synergise the effect of antibiotics while reaching to its site of action. This is a surprising finding, if there ever was one. Therefore, I looked a bit closer with a view of determining what the original data were that led to this conclusion.

Here is the unaltered section on homeopathy from the review:

Homeopathy is a special, organic, holistic medicine process which activates the healing responses of the body without any known contraindications or common side effects. In his book Organon of Medicine, aka Organon of Healing Art, the founder of Homeopathy, Samuel Hahnemann, developed these principles. Homoeopathy does not have holistic treatment and hence is incapable of curing TB because of homeopathic portions of water, which is not enough to treat TB, but recent research suggests the use of homeopathic treatment along with the antibiotics, which results in synergising the effect of antibiotics while reaching to its site of action. As standard MDR-TB medicines are second-generation antibiotics taken for 24–27 months, thus, apart from conventional treatment, homeopathy in MDR-TB tends to improve outcome. Hence, it increases the bioavailability of the isoniazid and rifampicin, which resulted in the reduction of tuberculosis therapy. This study has been proving by analysing following parameters as below:

There was no significant difference in smear conversion from positive to negative at 95 % CI between homeopathy (H) and individualised standard treatment regimen (SR) + placebo (P). However, the conversion culture conversion from positive to negative in SR + H was seen in 29 (48.3 %) patients and 23 (38.3 %) patients in SR + P group (p = 0.269) (ITT) and 27 (55.1 %); 21 (42.8 %), p = 0.225 (PP) implying that as compared to SR + P group, culture conversion in SR + H group was more by 10 %. So the difference, although favourable to the SR + H group is not statistically significant as shown in table 4.

All patients had far advanced lung disease as evident from the extensive infiltration, cavitation ns and fibrosis/collapse. Chest X-ray (CXR) were further assessed using RAT (Radiological Assessment Tool), examples of one case rated as + 5 and one case as _4. Significant improvements were seen statistically in CXR in the SR + H 37 (61.7 %); as compared to SR + P 20 (33.3 %), p = 0.002 at 95 % CI (ITT). Homeopathy system having all possibility to enhance the treatment and management of the TB [13].

To be clear: there is no further mention or discussion of homeopathy in this paper. The above-quoted section (its multiple falsehoods are so obvious that I probably don’t need to mention them here) is thus the only evidence provided for backing up the claim that Homeopathic treatment along with the antibiotics synergise the effect of antibiotics while reaching to its site of action. I fail to see how the information provided supports the claim. Moreover, I am not aware of any sound evidence that would support the claim that homeopathy acts synergistically to antibiotics.

In the reference list, I found one of my own articles cited as reference 13 (see above). It refers to this article: Ernst E. A systematic review of systematic reviews of homeopathy. Dr J Clin Pharmacol 2002; 54: 577–582. Here is its abstract:

Homeopathy remains one of the most controversial subjects in therapeutics. This article is an attempt to clarify its effectiveness based on recent systematic reviews. Electronic databases were searched for systematic reviews/meta-analysis on the subject. Seventeen articles fulfilled the inclusion/exclusion criteria. Six of them related to re-analyses of one landmark meta-analysis. Collectively they implied that the overall positive result of this meta-analysis is not supported by a critical analysis of the data. Eleven independent systematic reviews were located. Collectively they failed to provide strong evidence in favour of homeopathy. In particular, there was no condition which responds convincingly better to homeopathic treatment than to placebo or other control interventions. Similarly, there was no homeopathic remedy that was demonstrated to yield clinical effects that are convincingly different from placebo. It is concluded that the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice.

I fail to see how my paper backs up the very odd sentence: Homeopathy system having all possibility to enhance the treatment and management of the TB.

This is much more than sloppiness. In fact, it is one of the clearest cases of scientific misconduct I have ever come across. What is more, if its message would get adopted, it has the potential to do considerable harm. The authors of the paper in question, Priyanka Sharma , Ramesh K. Goyal,  and Mukesh Nandave, declared no conflicts of interest; their affiliation is provided as ‘Departments of Pharmacology and Toxicology, Delhi Pharmaceutical Sciences and Research University, New Delhi, India’. The journal that published their review is ‘Drug Research‘, a publication which I always had thought was reputable.

I am not sure what I should do next.

Any advice?

I have been sceptical about Craniosacral Therapy (CST) several times (see for instance here, here and here). Now, a new paper might change all this:

The systematic review assessed the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. Randomized clinical trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Pain intensity and functional disability were the primary outcomes. Risk of bias was assessed using the Cochrane tool.

Ten RCTs with a total of 681 patients suffering from neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included.

Compared to treatment as usual, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.32, 95%CI=[−0.61,-0.02])
  • disability (SMD=-0.58, 95%CI=[−0.92,-0.24]).

Compared to manual/non-manual sham, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.63, 95%CI=[−0.90,-0.37])
  • disability (SMD=-0.54, 95%CI=[−0.81,-0.28]) ;

Compared to active manual treatments, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.53, 95%CI=[−0.89,-0.16])
  • disability (SMD=-0.58, 95%CI=[−0.95,-0.21]) .

At six months, CST showed greater effects on pain intensity (SMD=-0.59, 95%CI=[−0.99,-0.19]) and disability (SMD=-0.53, 95%CI=[−0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.

The authors concluded that, in patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.

Robust effects! This looks almost convincing, particularly to an uncritical proponent of so-called alternative medicine (SCAM). However, a bit of critical thinking quickly discloses numerous problems, not with this (technically well-made) review, but with the interpretation of its results and the conclusions. Let me mention a few that spring into my mind:

  1. The literature searches were concluded in August 2018; why publish the paper only in 2020? Meanwhile, there might have been further studies which would render the review outdated even on the day it was published. (I know that there are many reasons for such a delay, but a responsible journal editor must insist on an update of the searches before publication.)
  2. Comparisons to ‘treatment as usual’ do not control for the potentially important placebo effects of CST and thus tell us nothing about the effectiveness of CST per se.
  3. The same applies to comparisons to ‘active’ manual treatments and ‘non-manual’ sham (the purpose of a sham is to blind patients; a non-manual sham defies this purpose).
  4. This leaves us with exactly two trials employing a sham that might have been sufficiently credible to be able to fool patients into believing that they were receiving the verum.
  5. One of these trials (ref 44) is far too flimsy to be taken seriously: it was tiny (n=23), did not adequately blind patients, and failed to mention adverse effects (thus violating research ethics [I cannot take such trials seriously]).
  6. The other trial (ref 41) is by the same research group as the review, and the authors award themselves a higher quality score than any other of the primary studies (perhaps even correctly, because the other trials are even worse). Yet, their study has considerable weaknesses which they fail to discuss: it was small (n=54), there was no check to see whether patient-blinding was successful, and – as with all the CST studies – the therapist was, of course, no blind. The latter point is crucial, I think, because patients can easily be influenced by the therapists via verbal or non-verbal communication to report the findings favoured by the therapist. This means that the small effects seen in such studies are likely to be due to this residual bias and thus have nothing to do with the intervention per se.
  7. Despite the fact that the review findings depend critically on their own primary study, the authors of the review declared that they have no conflict of interest.

Considering all this plus the rather important fact that CST completely lacks biological plausibility, I do not think that the conclusions of the review are warranted. I much prefer the ones from my own systematic review of 2012. It included 6 RCTs (all of which were burdened with a high risk of bias) and concluded that the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.

So, why do the review authors first go to the trouble of conducting a technically sound systematic review and meta-analysis and then fail utterly to interpret its findings critically? I might have an answer to this question. Back in 2016, I included the head of this research group, Gustav Dobos, into my ‘hall of fame’ because he is one of the many SCAM researchers who never seem to publish a negative result. This is what I then wrote about him:

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

Yesterday, we discussed a paper concluding (amongst other things) that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain. Today, we are looking at one that overtly contradicts this verdict.

This systematic review (published in JAMA Oncology) evaluated the existing randomized clinical trials (RCTs) for evidence of the association of acupuncture and acupressure with reduction in cancer pain. Randomized clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care for managing cancer pain were included. The primary outcome was pain intensity measured by the Brief Pain Inventory, Numerical Rating Scale, Visual Analog Scale, or Verbal Rating Scale.

A total of 17 RCTs (with 1111 patients) were included, and data from 14 RCTs (with 920 patients) were used in the meta-analysis. Seven sham-controlled RCTs (35%) were notable for their high quality, being judged to have a low risk of bias for all of their domains, and showed that real (compared with sham) acupuncture was associated with reduced pain intensity. A favourable association was also seen when acupuncture and acupressure were combined with analgesic therapy in 6 RCTs for reducing pain intensity and in 2 RCTs for reducing opioid dose. The evidence grade was moderate because of the substantial heterogeneity among studies.

The authors concluded that this systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of analgesics, although the evidence level was moderate. This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use.

So, which of the two conclusions should we trust?

Personally, I find the JAMA paper unimpressive to the point of being suspect. Here are some of my reasons:

  • About half of the primary studies are Chinese; and we have seen repeatedly that they are unreliable and report only positive results.
  • Many of the trials are published in Chinese and can thus not be checked by non-Chinese readers (nor, presumably, by the experts who acted as peer-reviewers for JAMA Oncology).
  • I have my doubts about the rigor of the peer-review of some of the journals that published the primary studies included in the review.
  • One paper included in the review is even a mere doctoral thesis which usually is not peer-reviewed in the usual sense.
  • The authors state that they included only clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care. However, this is evidently not true; many of the studies had the infamous A+B versus B design comparing acupuncture plus a conventional therapy against the conventional therapy. As we have discussed ad nauseam on this blog, such trials cannot produce a negative finding even if ‘A’ is a placebo.
  • Contrary to what the authors claim, the quality of most of the included studies was extremely poor, as far as I can see.
  • One included paper which I cannot access is entitled ‘Clinical observation on 30 cases of moderate and severe cancer pain of bone metastasis treated by auricular acupressure‘. Are the review authors seriously claiming that this is an RCT?

The more I study the details of the JAMA Oncology paper, the more I feel it might be worth a complaint to the editor with a view of initiating a thorough investigation and a possible retraction.

 

Many patients with chronic pain (CP) are prescribed opioids, a situation which has led to the much-discussed opioid crisis. Integrative medicine (IM), which combines pharmacological and so-called alternative medicine (SCAM), has been proposed as a solution. Yet, the role of SCAM therapies in reducing opioid use remains unclear.

This systematic review explored the effectiveness of the IM approach or any of the SCAM therapies to reduce or cease opioid use in CP patients. Electronic searches yielded 5,200 citations. Twenty-three studies were selected. Eight studies were randomized controlled trials, seven were retrospective studies, four studies were prospective observational, three were cross-sectional, and one was quasi-experimental. The majority of the studies showed that opioid use was reduced significantly after using IM/SCAM. Cannabinoids were among the most commonly investigated approaches in reducing opioid use, followed by multidisciplinary approaches, cognitive-behavioral therapy, and acupuncture. The majority of the studies had limitations related to sample size, duration, and study design.

The authors concluded that there is a small but defined body of literature demonstrating positive preliminary evidence that the IM approach including SCAM therapies can help in reducing opioid use. As the opioid crisis continues to grow, it is vital that clinicians and patients be adequately informed regarding the evidence and opportunities for IM/SCAM therapies for CP.

I am unimpressed by this review.

And here is why:

  1. Because of their design, most of the included studies do not allow any conclusions about cause and effect.
  2. The 8 RCTs that would allow such conclusions are mostly of poor quality.
  3. Some of the 8 RCTs are not even what the review authors claim to be. Here is just one example:

Background: Current levels and dangers of opioid use in the U.S. warrant the investigation of harm-reducing treatment alternatives.

Purpose: A preliminary, historical, cohort study was used to examine the association between enrollment in the New Mexico Medical Cannabis Program (MCP) and opioid prescription use.

Methods: Thirty-seven habitual opioid using, chronic pain patients (mean age = 54 years; 54% male; 86% chronic back pain) enrolled in the MCP between 4/1/2010 and 10/3/2015 were compared to 29 non-enrolled patients (mean age = 60 years; 69% male; 100% chronic back pain). We used Prescription Monitoring Program opioid records over a 21 month period (first three months prior to enrollment for the MCP patients) to measure cessation (defined as the absence of opioid prescriptions activity during the last three months of observation) and reduction (calculated in average daily intravenous [IV] morphine dosages). MCP patient-reported benefits and side effects of using cannabis one year after enrollment were also collected.

Results: By the end of the 21 month observation period, MCP enrollment was associated with 17.27 higher age- and gender-adjusted odds of ceasing opioid prescriptions (CI 1.89 to 157.36, p = 0.012), 5.12 higher odds of reducing daily prescription opioid dosages (CI 1.56 to 16.88, p = 0.007), and a 47 percentage point reduction in daily opioid dosages relative to a mean change of positive 10.4 percentage points in the comparison group (CI -90.68 to -3.59, p = 0.034). The monthly trend in opioid prescriptions over time was negative among MCP patients (-0.64mg IV morphine, CI -1.10 to -0.18, p = 0.008), but not statistically different from zero in the comparison group (0.18mg IV morphine, CI -0.02 to 0.39, p = 0.081). Survey responses indicated improvements in pain reduction, quality of life, social life, activity levels, and concentration, and few side effects from using cannabis one year after enrollment in the MCP (ps<0.001).

Conclusions: The clinically and statistically significant evidence of an association between MCP enrollment and opioid prescription cessation and reductions and improved quality of life warrants further investigations on cannabis as a potential alternative to prescription opioids for treating chronic pain.

This study is evidently NOT an RCT!

Most of the 8 RCTs investigate whether SCAM is useful for weaning opioid-dependent patients off their drug. To equate this with the question whether IM/SCAM can reduce or cease opioid use in CP patients is, I think, wrong. The way to reduce opioid use in CP patients is to prescribe less opioids. And for prescribing less opioids, we need no SCAM but we need to remember what we learned in medical school: opioids are not for routine treatment of CP!

So, why do the authors of this review try to mislead us?

Could it have something to do with some of their affiliations and the bias that goes with it?

  • Canadian College of Naturopathic Medicine, North York, Ontario, Canada.
  • Australian Research Centre in Complementary and Integrative Medicine, University of Technology Sydney, Ultimo, Australia.
  • Pacific College of Oriental Medicine, San Diego, California, USA.

What do you think?

The UK-based homeopathic pharmacy AINSWORTH has attracted my attention several times already. Amongst other things, Tony Pinkus, the director of the firm, once accused me of having faked my research and I suspected him of violating the basic principles of research ethics in his study of homeopathy for autism.

Today, THE DAILY MAIL reports about AINSWORTH’s scandalous promotion of the most dangerous quackery.

Tony Pinkus, director of AINSWORTH

Tony Pinkus, director of AINSWORTH

In a big article, the Mail informs the reader that:

  • AINSWORTH sell a guide (entitled ‘The Mother & And Child Remedy Prescriber’ and decorated with the codes of arms of both the Queen and Prince Charles) informing young mothers that homeopathy ‘will strengthen a child’s immune system more ably than any vaccine’.
  • The guide also claims that infections like mumps and measles can be treated homeopathically.
  • AINSWORTH sells homeopathic remedies used as vaccines against serious infections such as polio, measles, meningitis, etc.
  • AINSWORTH’s guide claim that homeopathy ‘offers the clearest answer as to how to deal with the prevention of disease’.
  • The guide claims furthermore that homeopathy is ‘a complete alternative to vaccination’.
  • It even lists 7 homeopathic remedies for measles.
  • AINSWORTH claim that homeopathy provides ‘natural immunity’.
  • AINSWORTH sell products called ‘polio nosode’, and ‘meningeoma nosode’.

The Mail quotes several experts – including myself – who do not mince their words in condemning AINSWORTH for jeopardising public health. The paper also calls for AINSWORTH’s two royal warrants to be removed.

AINSWORTH, Buckingham Palace, and Clarence House all declined to comment.

I just came across the most amazing cancer cure: it’s called VIDATOX 30C, and it is a true wonder.

Well, on second thought, I might take that this back.

Is it really true?

Or is it perhaps a most despicable health fraud?

The Vidatox website makes the following claims for VIDATOX:

  • it is based on 5 proteins from scorpion venom;
  • it is a 30C potency, which means that it is diluted by a factor of 1:1000000000000000000000000000000000000000000000000000000000000
  • it selectively acts on diseased cells without harming healthy ones;
  • it is angiogenic;
  • it stimulates the immune system;
  • it attacks growing tumours;
  • it is anti-metastatic;
  • it blocks tumour angiogenesis;
  • it has anti-inflammatory effects;
  • it has prolonged analgesic effects;
  • it enhances the effects of chemo- and radiation therapies;
  • it reduces the side-effects of chemo- and radiation therapies;
  • it is not addictive;
  • it is a therapeutic alternative for human cancers;
  • it is in general use in oncology;
  • it has a powerful detoxification effect;
  • it has no side-effects;
  • it improves the well-being of patients;
  • its efficiency in tumour treatment is proven;
  • the medication ‘passed all the clinical trials’;
  • it increases survival;
  • it is a ‘certified product’;
  • it should be kept away from electromagnetic fields.

With all these claims and all ths splendid science mentioned on the website, one would expect to find plenty of papers on Vidatox. A Medline search resulted in 1 (one!) paper on the subject. Here is the abstract:

Complementary and alternative medicine (CAM) is the term used to describe many kinds of products, practices, and systems that are not part of conventional medicine. Cancer patients usually do everything they can to combat the disease, manage its symptoms, and cope with the side effects of treatment. Unfortunately, patients who use CAM underestimate the risk of interaction with cancer therapy or worse they omit conventional therapy thus reducing the possibility of cancer remission. Herein we analyzed the effects of Vidatox 30 CH (venom extracted from the Junceus Rhopalurus scorpion) on hepatocellular carcinoma (HCC), the second leading cause of cancer-related deaths. We found out that Vidatox increases HCC proliferation and invasion whereas it does not seem to interact with sorafenib, the orally active multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma. Our results suggest that the concentration of Vidatox used in the present study has not anti-neoplastic effects and care must be taken in hiring Vidatox in patients with HCC.

The authors of this paper also make the following comment:

According to Gonzalez, Vidatox was tested on more than 10,000 cancer patients with “positive results” ranging from an “improved quality of life” to a “slowing of tumor growth” (http://vidatoxromania.ro/en/what-is-vidatox/) (http://www.bt.com.bn/science-technology/2010/10/29/cuba-release-new-cancer-drug). There are no data from controlled clinical studies neither for Escozul nor for Vidatox 30-CH in refereed journals. The available information derived from interviews with patients involved or provided within the sites of alternative therapies. Essentially, scientific evidences about the biological activity of Vidatox in cancer cells are missing.

So, is Vidatox homeopathy’s answer to cancer or is it simply a disgusting fraud?

What do you think?

Professor Anthony Pelosi just published an intriguing paper. Here is the abstract:

During the 1980s and 1990s, Hans J Eysenck conducted a programme of research into the causes, prevention and treatment of fatal diseases in collaboration with one of his protégés, Ronald Grossarth-Maticek. This led to what must be the most astonishing series of findings ever published in the peer-reviewed scientific literature with effect sizes that have never otherwise been encounterered in biomedical research. This article outlines just some of these reported findings and signposts readers to extremely serious scientific and ethical criticisms that were published almost three decades ago. Confidential internal documents that have become available as a result of litigation against tobacco companies provide additional insights into this work. It is suggested that this research programme has led to one of the worst scientific scandals of all time. A call is made for a long overdue formal inquiry.

The Guardian reported further details on this story sating that the work of one of the most famous and influential British psychologists of all time, Hans Eysenck, is under a cloud following an investigation by King’s College London, which has found 26 of his published papers “unsafe”.

In relation to so-called alternative medicine (SCAM), it is foremost this claim of Eysenck that is relevant:

It is argued that there is now suficient evidence to regard psychosocial variables, in
particular personality and stress, as important risk factors for cancer and coronary heart
disease (CHD), equal in importance to smoking, heredity, cholesterol level, blood pressure,
and other physical variables. Furthermore, it is now clear that both types of factors act
synergistically; that is, each by itself is relatively benign, but their effects multiply to produce
high levels of disease…

The claim (which Eysenck published many times over, for instance here) was picked up and promoted by many believers in SCAM. This might have been helped by Eysenck’s bizarre openness to all things paranormal. Today his belief of a link between personality/stress and cancer is deeply engrained in SCAM.

King’s College says the results and conclusions of the papers “were not considered scientifically rigorous” by its committee of inquiry. Prof Sir Robert Lechler, the provost at King’s, has contacted the editors of the 11 journals where the papers appeared, recommending they should be retracted.

Prof Anthony Pelosi, consultant psychiatrist at the Priory Hospital, Glasgow, whose own investigation prompted the inquiry by King’s, said their work “led to what must be the most astonishing series of findings ever published in the peer-reviewed scientific literature, with effect sizes that have never otherwise been encountered in biomedical research”.

Among more than 3,000 people in the studies, Eysenck and his colleague claimed people with a “cancer-prone” personality were 121 times more likely to die of the disease than those without. Cancer-prone personalities were described as generally passive in the face of stress from outside.

Eysenck and Grossarth-Maticek apparently even had a cure for cancer. In one study, they gave 600 “cancer-prone” individuals a leaflet on how to be more “autonomous” and take control of their destiny. It contained such advice as: “Your aim should always be to produce conditions which make it possible for you to lead a happy and contented life.” It appeared to deliver miracles. Over 13 years, the 600 people randomly assigned to bibliotherapy, as it was called, had all-cause mortality of 32%, compared with 82% of 600 people not fortunate enough to receive a leaflet.

“I honestly believe, having read it so carefully and tried to find alternative interpretations, that this is fraudulent work,” said Pelosi, who is concerned Eysenck’s ideas still have a following. “His acolytes always bragged he was the most cited psychologist of all time… In the social sciences citation index, he was number three. Number two was Freud. Number one was Karl Marx. He was hugely prolific, widely cited and very influential… Many fringe medical practitioners hold the same conviction.”

Traditional Chinese Medicine (TCM) is a term created by Mao lumping together various modalities in an attempt to pretend that healthcare in the People’s Republic of China (PRC) was being provided despite the most severe shortages of conventional doctors, drugs and facilities. Since then, TCM seems to have conquered the West, and, in the PRC, the supply of conventional medicine has hugely increased. Today therefore, TCM and conventional medicine peacefully co-exist side by side in the PRC on an equal footing.

At least this is what we are being told – but is it true?

I have visited the PRC twice. The first time, in 1980, I was the doctor of a university football team playing several games in the PRC, including one against their national team. The second time, in 1991, I co-chaired a scientific meeting in Shanghai. On both occasions, I was invited to visit TCM facilities and discuss with colleagues issues related to TCM in the PRC. All the official discussions were monitored by official ‘minders’, and therefore fee speech and an uninhibited exchange of ideas are not truly how I would describe them. Yet, on both visits, there were occasions when the ‘minders’ were absent and a more liberal discussion could ensue. Whenever this was the case, I did not at all get the impression that TCM and conventional medicine were peacefully co-existing. The impression that I did get was that their co-existence resembled more a ‘shot-gun marriage’.

During my time running the SCAM research unit at Exeter, I had the opportunity to welcome several visiting researchers from the PRC. This experience seemed to confirm my impression that TCM in the PRC was less than free. As an example, I might cite one acupuncture project I was once working on with a scientist from the PRC. When it was nearing its conclusion and I mentioned that we should now think about writing it up to publish the findings, my Chinese colleague said that being a co-author was unfortunately not an option. Knowing how important publications in Western journals are for researchers from the PRC, I was most surprised by this revelation. The reason, it turned out, was that our findings failed to be favourable for TCM. My friend explained that such a paper would not advance but hinder an academic career, once back in the PRC.

Suspecting that the notion of a peaceful co-existence of TCM and conventional medicine in the PRC was far from true, I have always been puzzled how the myth could survive for so many years. Now, finally, it seems to crumble. This is from a recent journalistic article entitled ‘Chinese Activists Protest the Use of Traditional Treatments – They Want Medical Science’ which states that thousands of science activists in the PRC protest that the state neglects its duty to treat its citizens with evidence-based medicine (here is the scientific article this is based on):

Over a number of years, Chinese researcher Qiaoyan Zhu, who has been affiliated with the University of Copenhagen’s Department of Communication, has collected data on the many thousand science activists in China through observations in Internet forums, on social media and during physical meetings. She has also interviewed hundreds of activists. Together with Professor Maja Horst, who has specialized in research communication, she has analyzed the many data on the activists and their protests in an article that has just been published in the journal Public Understanding of Science:

“The activists are better educated and wealthier than the average Chinese population, and a large majority of them keep up-to-date with scientific developments. The protests do not reflect a broad popular movement, but the activists make an impact with their communication at several different levels,” Maja Horst explained and added: “Many of them are protesting individually by writing directly to family, friends and colleagues who have been treated with – and in some cases taken ill from – Traditional Chinese Medicine. Some have also hung posters in hospitals and other official institutions to draw attention to the dangers of traditional treatments. But most of the activism takes place online, on social media and blogs.

Activists operating in a regime like the Chinese are obviously not given the same leeway as activists in an open democratic society — there are limits to what the authorities are willing to accept in the public sphere in particular. However, there is still ample opportunity to organize and plan actions online.

“In addition to smaller groups and individual activists that have profiles on social media, larger online groups are also being formed, in some cases gaining a high degree of visibility. The card game with 52 criticisms about Traditional Chinese Medicine that a group of activists produced in 37,000 copies and distributed to family, friends and local poker clubs is a good example. Poker is a highly popular pastime in rural China so the critical deck of cards is a creative way of reaching a large audience,” Maja Horst said.

Maja Horst and Qiaoyan Zhu have also found examples of more direct action methods, where local activist groups contact school authorities to complain that traditional Chinese medicine is part of the syllabus in schools. Or that activists help patients refuse treatment if they are offered treatment with Traditional Chinese Medicine.

________________________________________________________________

I am relieved to see that, even in a system like the PRC, sound science and compelling evidence cannot be suppressed forever. It has taken a mighty long time, and the process may only be in its infancy. But there is hope – perhaps even hope that the TCM enthusiasts outside the PRC might realise that much of what came out of China has led them up the garden path!?

 

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