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

scientific misconduct

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The objective of this review (entitled ‘Systematic Review on the Use of Homeopathy in Dentistry:
Critical Analysis of Clinical Trials‘) was to map the literature on homeopathy in dentistry and to evaluate the effectiveness of using homeopathy in dental practice through the critical analysis of clinical studies.

The search for scientific articles in any language, year, and place of publication was made in the databases of Public Medline (PUBMED), Web of Science, Cochrane, and Virtual Health Library; the articles selected were later classified according to the type of study. Gray literature was accessed through Google Scholar. Clinical trials were analyzed for methodological quality. Two trained reviewers accomplished the entire process independently.

Of the 281 studies retrieved by means of the search, 44 met the eligibility criteria. The included papers were:

  • literature reviews (56.8%),
  • clinical trials (34.1%),
  • cross-sectional studies (6.8%),
  • laboratory research (6.8%),
  • longitudinal observational studies (4.5%).

The clinical trials were published from 1965 to 2019, using homeopathy in several dental specialties:

  • Endodontics,
  • Periodontics,
  • Orofacial Pain,
  • Surgery,
  • Pediatric Dentistry,
  • Stomatology,
  • dental anxiety.

Qualitative failures, in all criteria investigated, and positive influences of the individual prescriptions on the results of treatments reported were observed.

The authors concluded that there is still a scarcity of studies about homeopathy and dentistry. The clinical trials selected showed positive effects on oral health; however, when they were critically evaluated, it was possible to recognize qualitative failures, mainly relative to double-blinding. It is necessary to encourage research on the subject, using standardized methodological procedures, to obtain better evaluation of the clinical applicability.

According to the authors, their review adhered to the PRISMA guideline of systematic reviews. This is, however, not the case. The authors correctly point out that the primary studies had many flaws: methodological failures were observed in the clinical trials, mainly related to double-blinding (66.7%). Significant failures were also observed in similarity (61.1%), randomization (27.8%), description of losses and exclusions (27.8%), and exclusion criteria (27.8%). They do not seem to realize that flaws of this nature and frequency should prevent positive conclusions.

So, what does this paper actually demonstrate? In my view, it shows that:

  • the peer-review process at the JACM continues to be a joke;
  • poor quality trials run by enthusiasts tend to produce false-positive results;
  • in so-called alternative medicine (SCAM), people get away with publishing even the most obvious falsehoods.

Tuina is a massage therapy that originates from Traditional Chinese Medicine. Many of the techniques used in tuina resemble those of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing, and shaking. Tuina involves a range of manipulations usually performed by the therapist’s finger, hand, elbow, knee, or foot. They are applied to muscle or soft tissue at specific locations of the body.

The aim of Tuina is to enhance the flow of the ‘vital energy’ or ‘chi’, that is alleged to control our health. Proponents of the therapy recommend Tuina for a range of conditions, including paediatric ones. Paediatric Tuina has been widely used in children with acute diarrhea in China. However, due to a lack of high-quality clinical evidence, the benefit of Tuina is not clear.

This study aimed to assess the effect of paediatric Tuina compared with sham Tuina as add-on therapy in addition to usual care for 0-6-year-old children with acute diarrhea.

Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed.

Tuina treatment in the intervention group was performed on the surface of the children’s body using moderate pressure (Fig. 1a). Tuina treatment in the control group was different: the therapist used one hand to hold the child’s hand or put one hand on the child’s body, while the other hand performed manipulations on the therapist’s own hand instead of the child’s hand or body (Fig. ​(Fig.11b).

Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT and per-protocol analyses. However, the results were not significant when adjusted for social-demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal.

The authors concluded that in children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy.

This study was well-reported and has interesting features, such as the attempt to use a placebo control and blinding (whether blinding was successful is a different matter and was not tested in the trial). It is, therefore, all the more surprising that the essentially negative result is turned into a positive one. After adjustment, the differences disappear (a fact which the authors hardly mention in the paper), which means they are not due to the treatment but to group differences and confounding. This, in turn, means that the study shows not the effectiveness but the ineffectiveness of Tuina.

As though the UK does not have plenty of organisations promoting so-called alternative medicine (SCAM)! Obviously not – because a new one is about to emerge.

In mid-January, THE COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMIH) will launch the Integrated Medicine Alliance bringing together the leaders of many complementary health organisations to provide patients, clinicians and policy makers with information on the various complementary modalities, which will be needed in a post COVID-19 world, where:

  1. patient choice is better respected,
  2. requirements for evidence of efficacy are more proportionate to the seriousness of the disease and the safety of the intervention,
  3. and where benefit versus risk are better balanced.

We already saw this in 2020 with the College advocating from the very beginning of the year that people should think about taking Vitamin D, while the National Institute for Clinical Excellence continued to say the evidence was insufficient, but the Secretary of State has now supported it being given to the vulnerable on the basis of the balance between cost, benefit and safety.

Elsewhere we learn more about the Integrated Medicine Alliance (IMA):

The IMA is a group of organisations and individuals that have been brought together for the purpose of encouraging and optimising the best use of complementary therapies alongside conventional healthcare for the benefit of all.

The idea for this group was conceived by Dr Michael Dixon in discussion with colleagues associated with the College of Medicine, and the initial meeting to convene the group was held in February 2019.

The group transitioned through a number of titles before settling on the ‘Integrated Medicine Alliance’ and began work on developing a patient leaflet and a series of information sheets on the key complementary therapies.

It was agreed that in the first instance the IMA should exist under the wing of the College of Medicine, but that in the future it may develop into a formal organisation in its own right, but inevitably maintaining a close relationship with the College of Medicine.

The IMA also offers ‘INFORMATION SHEETS’ on the following modalities:

I find those leaflets revealing. They tell us, for example that the Reiki practitioner channels universal energy through their hands to help rebalance each of the body’s energy centres, known as chakras. About homeopathy, we learn that a large corpus of evidence has accumulated which stands the most robust tests of modern science. And about naturopathy, we learn that it includes ozone therapy but is perfectly safe.

Just for the fun of it – and free of charge – let me try to place a few corrections here:

  • Reiki healers use their hands to perform what is little more than a party trick.
  • The universal energy they claim to direct does not exist.
  • The body does not have energy centres.
  • Chakras are a figment of imagination.
  • The corpus of evidence on homeopathy is by no means large.
  • The evidence is flimsy.
  • The most robust tests of modern science fail to show that homeopathy is effective beyond placebo.
  • Naturopathy is a hotchpotch of treatments most of which are neither natural nor perfectly safe.

One does wonder who writes such drivel for the COMIH, and one shudders to think what else the IMA might be up to.

This is an analysis that I have long hesitated to conduct. The reason for my hesitation is simple: some people might think it is vindictive, revengeful or ad hominem. After reflecting about it for years, I have now decided to go ahead with it (sorry, it’s a bit lengthy). This case study is not meant to be vindictive, but offers an important insight into the power of conflicts of interest in SCAM that are not financial but ideological. I think it is crucial that people are aware of and consider such conflicts carefully, and I can’t see how else I might demonstrate my point so plainly.

Dr Adrian White was a co-worker of mine for about 10 years. He became a trusted colleague, my ‘right hand’ man and even my deputy at my Exeter department. When I discovered that my trust had been misplaced, I did not prolong his contract (I will not dwell on this episode, those who are interested find it in my memoir). Adrian then got a senior research fellowship with Prof John Campbell (not my favourite colleague at Exeter) at the department of general practice where he continued his research on acupuncture for about 10 more years largely unsupervised.

Adrian had been an acupuncturist body and soul (in fact, I had never before met anyone so utterly convinced of the value of this therapy). When he joined my team, he was scientifically naive, and we spent many month trying to teach him how to think like a scientist. Initially, he found it very difficult to think critically about acupuncture. Later, I thought the problem was under control. Yet, most of his research in my department was guided by me and tightly supervised (i.e. I made sure that out studies were testing rather than promoting SCAM, and that our reviews were critical assessments of the existing evidence).

Thus there exist two separate and well-documented periods of a pro-acupuncture researcher:

  • 10 years guided by me and members of my team;
  • 10 years largely unsupervised.

What could be more tempting than to compare Adrian’s output during these two periods?

To do this, I looked up all of Adrian’s 120 publications on acupuncture and selected those 52 articles that generated factual new data (mostly clinical trials or systematic reviews). As it happens, they are numerically distributed almost equally within the two periods. The endpoints for my analysis were the directions of the conclusions of his papers. I therefore extracted, dated, and rated the 52 articles as follows:

  • P = positive from the point of view of an acupuncture advocate,
  • N = negative from the point of view of an acupuncture advocate.
  • P/N = not clearly pointing in either direction.

To render this exercise transparent (occasionally, I was not entirely sure about my ratings), I copied all the 52 conclusions and provided links to the original papers so that anyone inferested is able to check easily.

Here are my findings. Articles 1 – 27 were published AFTER Adrian had left my department; articles 28 – 52 are his papers from the time while he worked with me.

  1. A definitive three-arm trial is feasible. Further follow-up reminders, minimum data collection and incentives should be considered to improve participant retention in the follow-up processes in the standardised advice and exercise booklet arm. (2016) P/N
  2. The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking. (2016) P
  3. The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials – particularly comparing acupuncture with other treatment options – are needed. (2016) P
  4. Acupuncture during pregnancy appears to be associated with few AEs when correctly applied. (2014) P
  5. Although pooled estimates suggest possible short-term effects there is no consistent, bias-free evidence that acupuncture, acupressure, or laser therapy have a sustained benefit on smoking cessation for six months or more. However, lack of evidence and methodological problems mean that no firm conclusions can be drawn. Electrostimulation is not effective for smoking cessation. Well-designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions. (2014) P
  6. The current evidence suggests that acupuncture may have some effects on drug dependence that have been missed because of choice of outcome in many previous studies, and future studies should use outcomes suggested by clinical experience. Body points and electroacupuncture, used in the original clinical observation, justify further research. (2013) P
  7. Acceptability is very high and may be maximised by taking a number of factors into account: full information should be provided before treatment begins; flexibility should be maintained in the appointment system and different levels of contact between fellow patients should be fostered; sufficient space and staffing should be provided and single-sex groups used wherever possible. (2012) P
  8. This is the first evaluation of nurse-led group (multibed) acupuncture clinics for patients with knee osteoarthritis to include a 2 year follow-up. It shows the practicability of offering a low-cost acupuncture service as an alternative to knee surgery and the service’s success in providing long-term symptom relief in about a third of patients. Using realistic assumptions, the cost consequences for the local commissioning group are an estimated saving of £100 000 a year. Sensitivity analyses are presented using different assumptions. (2012) P
  9. There is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but lack of evidence and methodological problems mean that no firm conclusions can be drawn. Further, well designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions. (2011) P/N
  10. Eight (8) of 10 international acupuncture experts were able to reach consensus on the syndromes, symptoms, and treatment of postmenopausal women with hot flashes. The syndromes were similar to those used by practitioners in the ACUFLASH clinical trial, but there were considerable differences between the acupuncture points. This difference is likely to be the result of differences in approach of training schools, and whether it is relevant for clinical outcomes is not well understood. (2011) P
  11. 70% of those patients eligible to participate volunteered to do so; all participants had clinically identified MTrPs; a 100% completion rate was achieved for recorded self-assessment data; no serious adverse events were reported as a result of either intervention; and the end of treatment attrition rate was 17%. A phase III study is both feasible and clinically relevant. This study is currently being planned. (2010) P
  12. In conclusion, the results from all studies are in agreement with the hypothesis that acupuncture needling relieves hot flushes. There are few data however supporting the hypothesis that the effect of acupuncture is point specific. Future research should investigate whether there is a biological effect of needling on hot flushes or not, whether tailored treatment is superior to standardised treatment, and ways of delivering treatment that causes least discomfort and least cost. (2010) P
  13. Acupuncture can contribute to a more rapid reduction in vasomotor symptoms and increase in health-related quality of life in postmenopausal women but probably has no long-term effects. (2010) P
  14. within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population. (2009) N/P
  15. factors other than the TCM syndrome diagnoses and the point selection may be of importance regarding the outcome of the treatment. (2009) N/P
  16. Acupuncture plus self-care can contribute to a clinically relevant reduction in hot flashes and increased health-related quality of life in postmenopausal women. (2009) P
  17. the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches. (2009) P
  18. there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of ‘true’ acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment. (2009) P
  19. We have conducted the first survey of the effects of provision of acupuncture in UK general practice, using data provided by the NHS, and uncovered a wide variation in the availability of the service in different areas. We have been unable to demonstrate any consistent differences in the prescribing or referral rates that could be due to the use of acupuncture in these practices. The wide variation in the data means that if such a trend exists, a very large survey would be needed to identify it. However, we discovered inaccuracies and variations in presentation of data by the PCTs which have made the numerical input, and hence our results, unreliable. Thus the practicalities of access to data and the problems with data accuracy would preclude a nationwide survey. (2008) P
  20. In conclusion, there is limited evidence deriving from one study that deep needling directly into myofascial trigger points has an overall treatment effect when compared with standardised care. Whilst the result of the meta-analysis of needling compared with placebo controls does not attain statistically significant, the overall direction could be compatible with a treatment effect of dry needling on myofascial trigger point pain. However, the limited sample size and poor quality of these studies highlights and supports the need for large scale, good quality placebo controlled trials in this area. (2009) P
  21. We conclude that limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy. (2008) P
  22. Acupuncture appears to offer symptomatic improvement to some patients with fibromyalgia in a tertiary clinic who have failed to respond to other treatments. In view of its safety, further acupuncture research is justified in this population. (2007) P
  23. It is speculated that optimal results from acupuncture treatment for osteoarthritis of the knee may involve: climatic factors, particularly high temperature; high expectations of patients; minimum of four needles; electroacupuncture rather than manual acupuncture, and particularly, strong electrical stimulation to needles placed in muscle; and a course of at least 10 treatments. These factors offer some support to criteria for adequate acupuncture used in the recent review. In addition, ethnic and cultural factors may influence patients’ reporting of their symptoms, and different versions of an outcome measure are likely to differ in their sensitivity – both factors which may lead to apparent rather than real differences between studies. The many variables in a study are likely to be more tightly controlled in a single centre study than in multicentre studies.  (2007) P
  24. Any effects of acupressure on smoking withdrawal, as an adjunct to the use of NRT and behavioural intervention, are unlikely to be detectable by the methods used here and further preliminary studies are required before the hypothesis can be tested. (2007) P
  25. Auricular acupuncture appears to be effective for smoking cessation, but the effect may not depend on point location. This calls into question the somatotopic model underlying auricular acupuncture and suggests a need to re-evaluate sham controlled studies which have used ‘incorrect’ points. Further experiments are necessary to confirm or refute these observational conclusions. (2006) P
  26. Acupuncture that meets criteria for adequate treatment is significantly superior to sham acupuncture and to no additional intervention in improving pain and function in patients with chronic knee pain. Due to the heterogeneity in the results, however, further research is required to confirm these findings and provide more information on long-term effects. (2007) P
  27. There is no consistent evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but methodological problems mean that no firm conclusions can be drawn. Further research using frequent or continuous stimulation is justified. (2006) N/P
  28. Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients.  (2005) N
  29. The evidence from controlled trials is insufficient to conclude whether acupuncture is an effective treatment for depression, but justifies further trials of electroacupuncture. (2005) N
  30. Acupuncture effectively relieves chronic low back pain. No evidence suggests that acupuncture is more effective than other active therapies. (2005) N/P
  31. In view of the small number of studies and their variable quality, doubt remains about the effectiveness of acupuncture for gynaecological conditions. Acupuncture and acupressure appear promising for dysmenorrhoea, and acupuncture for infertility, and further studies are justified. (2003) N
  32.  In conclusion, the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects, and is inactive, where the specific needle sensation (de qi) is taken as a surrogate measure of activity. It is therefore a valid control for acupuncture trials. The findings also lend support to the existence of de qi, a major concept underlying traditional Chinese acupuncture. (2002) N/P
  33. There is no clear evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation. (2002) N
  34. Collectively, these data imply that acupuncture is superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo. (2002) N/P
  35. In conclusion, the incidence of adverse events following acupuncture performed by doctors and physiotherapists can be classified as minimal; some avoidable events do occur. Acupuncture seems, in skilled hands, one of the safer forms of medical intervention. (2001) N/P
  36. Based on the evidence of rigorous randomised controlled trials, there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation. Further, better-designed studies are warranted. (2001) N
  37. Although it has already been demonstrated that severe adverse events seem to be uncommon in standard practice, many serious cases of negligence have been found in the present review, suggesting that training system for acupuncturists (including medical doctors) should be improved and that unsupervised self-treatment should be discouraged. (2001) N
  38. Direct needling of myofascial trigger points appears to be an effective treatment, but the hypothesis that needling therapies have efficacy beyond placebo is neither supported nor refuted by the evidence from clinical trials. Any effect of these therapies is likely because of the needle or placebo rather than the injection of either saline or active drug. Controlled trials are needed to investigate whether needling has an effect beyond placebo on myofascial trigger point pain. (2001) N/P
  39. Although the incidence of minor adverse events associated with acupuncture may be considerable, serious adverse events are rare. Those responsible for establishing competence in acupuncture should consider how to reduce these risks. (2001) N
  40. In conclusion, this study does not provide evidence that this form of acupuncture is effective in the prevention of episodic tension-type headache. (2000) N
  41. The present study provides no strong evidence to support the hypothesis that the acupuncture point SP6 is more tender in women and in men. Recommendations for further investigations are discussed.  (2000) N
  42. Acupuncture has not been demonstrated to be efficacious as a treatment for tinnitus on the evidence of rigorous randomized controlled trials. (2000) N
  43. We conclude that acupuncture continues to be associated with occasional, serious adverse events and fatalities. These events have no geographical limits. Most of these events are due to negligence. Everyone concerned with setting standards, delivering training, and maintaining competence in acupuncture should familiarise themselves with the lessons to be learnt from these untoward events. (2000) N
  44. Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions. (1999) N/P
  45. While the frequency of adverse effects of acupuncture is unknown and they may be rare, knowledge of normal anatomy and anatomical variations is essential for safe practice and should be reviewed by regulatory bodies and those responsible for training courses. (1999) N
  46.  In conclusion, the hypothesis that acupuncture is efficacious in the treatment of neck pain is not based on the available evidence from sound clinical trials. Further studies are justified. (1999) N
  47. Even though all studies are in accordance with the notion that acupuncture is effective for temporomandibular joint dysfunction, this hypothesis requires confirmation through more rigorous investigations. (1999) N
  48. Acupuncture is not free of risks. All adverse events reported in 1997 would have been avoidable. The absolute number of cases is small, but the degree of underreporting remains unknown. (1999) N
  49. This form of electroacupuncture is no more effective than placebo in reducing nicotine withdrawal symptoms. (1998) N
  50. Acupuncture was shown to be superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo. (1998) N/P
  51. Considerable variation was observed in the scores awarded by the acupuncture experts. (1998) N
  52. It is therefore concluded that, according to the data published to date, the evidence that acupuncture is a useful adjunct for stroke rehabilitation is encouraging but not compelling. More and better trials are required to clarify this highly relevant issue. (1996) N

The results are remarkable (particularly considering that one would not expect unbiased studies or reviews of acupuncture to generate plenty of positive conclusions):

0 times N, 5 times N/P, 22 times P – after Adrian had left my department,

17 times N, 7 times N/P, 0 times P – while Adrian worked in my department.

From these figures, it is tempting to calculate the ratios for both periods of negative : positive conclusions:

zero versus infinite

If that is not impressive, I don’t know what is!

Looking just at the positive and the negative papers over the years:

One could discuss these papers in more detail, but I think this is hardly necessary. Just a few highlights perhaps: look at articles No 5, 20 and 27 for examples of turning an essentially negative finding into a positive conclusion. Notice that Adrian conducted a clinical trial of acupuncture for smoking cessation (No 49) while working with me and later published uncritical positive reviews on the subject. Does this not indicate that he distrusted his own study because it had not generated the result he had hoped for?

Of course, my analysis is merely a case study and therefore my findings are not generalisable. However, in my personal experience, the described phenomenon is by no means an exception in SCAM research. I have observed similar phenomena over and over again. Just look at the ALTERNATIVE MEDICINE HALL OF FAME that I created for this blog:

But Adrian’s case might be unique because it allows us to make a longitudinal observation over two decades. And it suggests to me that an ideological bias can (and often is) so strong and indistructable that is re-emerges as soon as it is no longer kept under strict control.

I have long suspected that ideological conflicts of interest have a much more powerful influence in SCAM research than financial ones. Such an overpowering influence might even be characteristic to much of SCAM research. And because it can be so dominant, it seems important to know about. People reading research need to be aware that it originates from a biased source, and funders who finance research would be wise to think twice about supporting researchers who are likely to generate findings that are biased and therefore false-positive. In the final analysis, such research is worse than no research at all.

We are all prone to fall victim to the ‘post hoc ergo propter hoc’ fallacy. It describes the erroneous assumption that something that happened after an event was cased by that event. The fallacy is essentially due to confusing correlation with causation:

  • the sun does not rise because the rooster has crowed;
  • yellow colouring of the 2nd and 3rd finger of a smoker is not the cause of lung cancer;
  • some children developing autism after vaccinations does not mean that autism is caused by vaccination.

As I said, we are all prone to this sort of thing, even though we know better. Scientists, journal editors and reviewers of medical papers, however, should not allow themselves to be fooled by overt cases of the ‘post hoc ergo propter hoc’ fallacy. And if they do, they have lost all credibility – just like the individuals involved in a recent paper on animal homeopathy.

Pododermatitis in penguins usually occurs after changes in normal activity that result from being held captive. It is also called ‘bumlefoot’ (which fails to reflect the seriousness of the condition) and amounts to one of most frequent and important clinical complications in penguins kept in captivity or in rehabilitation centres.

This veterinary case study reports the use of oral homeopathic treatment on acute and chronic pododermatitis in five Magellanic penguins in a zoological park setting. During treatment, the patients remained in the penguins’ living area, and the effect of the treatment on the progression of their lesions was assessed visually once weekly. The treatment consisted of a combination of Arnica montana and Calcarea carbonica.

After treatment, the appearance of the lesions had noticeably improved: in the majority of penguins there was no longer evidence of infection or edema in the feet. The rate of recovery depended on the initial severity of the lesion. Those penguins that still showed signs of infection nevertheless exhibited a clear diminution of the size and thickness of the lesions. Homeopathic treatment did not cause any side effects.

The authors concluded that homeopathy offers a useful treatment option for pododermatitis in captive penguins, with easy administration and without side effects.

So, the homeopathic treatment happened before the recovery and, according to the ‘post hoc ergo propter hoc’ fallacy, the recovery must have been caused by the therapy!

I know, this is a tempting conclusion for a lay person, but it is also an unjustified one, and the people responsible for this paper are not lay people. Pododermitis does often disappear by itself, particularly if the hygenic conditions under which the penguins had been kept are improved. In any case, it is a potentially life-threatening condition (a bit like an infected bed sore in an immobilised human patient) that can be treated, and one should certainly not let a homeopath deal with it.

I think that the researchers who wrote the article, the journal editor who accepted it for publication, and the referees who reviewed the paper should all bow their heads in shame and go on a basic science course (perhaps a course in medical ethics as well) before they are let anywhere near research again.

Numerous so-called alternative medicines (SCAMs) have been touted as the solution for COVID-19. In fact, it is hard to find a SCAM that is not claimed to be useful for corona patients. Crucially, such claims are being made in the complete absence of evidence. A recent paper offers a bibliometric analysis of global research trends at the intersection of SCAM and COVID-19.

SCOPUS, MEDLINE, EMBASE, AMED and PSYCINFO databases were searched on July 5, 2020. All publication types were included, however, articles were only deemed eligible, if they made mention of one or more SCAMs for the potential prevention, treatment, and/or management of COVID-19 or a health issue indirectly resulting from the COVID-19 pandemic. The following eligible article characteristics were extracted: title; author names, affiliations, and countries; DOI; publication language; publication type; publication year; journal (and whether it is TICAM-focused); 2019 impact factor, and TICAMs mentioned.

A total of 296 eligible articles were published by 1373 unique authors at 977 affiliations across 56 countries. The most common countries associated with author affiliation included:

  • China,
  • the United States,
  • India,
  • Italy.

Four journals had published more that 10 papers each on the subject:

  • Chinese Traditional and Herbal Drugs,
  • Journal of Biomolecular Structure & Dynamics,
  • Zhongguo Zhongyao Zazhi (China Journal of Chinese Materia Medica),
  • Pharmacological Research

The vast majority of articles were published in English, followed by Chinese. Eligible articles were published across 157 journals, of which 33 were SCAM-focused; a total of 120 journals had a 2019 impact factor, which ranged from 0.17 to 60.392. A total of 327 different SCAMs were mentioned across eligible articles, with the most common ones including:

  • traditional Chinese medicine (n = 94),
  • vitamin D (n = 67),
  • melatonin (n = 16),
  • phytochemicals (n = 12),
  • general herbal medicine (n = 11).

The Canadian author concluded that this study provides researchers and clinicians with a greater knowledge of the characteristics of articles that been published globally at the intersection of COVID-19 and SCAM to date. At a time where safe and effective vaccines and medicines for the prevention and treatment of COVID-19 have yet to be discovered, this study provides a current snapshot of the quantity and characteristics of articles written at the intersection of SCAM therapies and COVID-19.

If anyone repeated the research today, I fear that the number of different SCAMs would have at least doubled. There is simply no form of SCAM that would not have joined the bandwagon of snake-oil salesmen trying to make a quick buck or satisfying their dangerous delusion of a panacea. Today (11/12/2020) my very quick Medline search on just a few SCAMs resulted in the following:

  • Herbal medicine: 253
  • Dietary supplement: 139
  • Acupuncture: 68
  • Homeopathy (not mentioned at all above): 20
  • Chiropractic: 13
  • Naturopathy: 6

One of the most chilling reads during my ‘rough and ready’ trawl through the literature was an article co-authored by a Viennese professor who has featured repeatedly on this blog. Here is its abstract:

Successful homeopathic prescriptions are based on careful individualization of symptoms, either for an individual patient or collectively in the case of epidemic outbreaks. The ongoing COVID-19 pandemic was initially represented as a severe acute respiratory illness, with eventual dramatic complications. However, over time it revealed to be a complex systemic disease with manifestations derived from viral-induced inflammation and hypercoagulability, thus liable to affect any body organ or system. As a result, clinical presentation is variable, in addition to variations associated with several individual and collective risk factors. Given the extreme variability of pathology and clinical manifestations, a single, or a few, universal homeopathic preventive Do not split medicine(s) do not seem feasible. Yet homeopathy may have a relevant role to play, inasmuch as the vast majority of patients only exhibit the mild form of disease and are indicated to self-care at home, without standard monitoring, follow-up, or treatment. For future pandemics, homeopathy agencies should prepare by establishing rapid-response teams and efficacious lines of communication.

The Canadian author of the above paper did not analyse how many of the papers he included would make therapeutic claims. I suspect that the majority did. In this context, one of the clearest indications of how deluded SCAM practitioners tend to be during these difficult times was provided by this paper:

Coronavirus disease 2019 (COVID-19), caused by a new coronavirus, first appeared in late 2019. What initially seemed to be a mild influenza quickly revealed itself as a serious and highly contagious disease, and the planet was soon faced with a significant morbidity and mortality associated with this pathogen. For homeopathy, shunned during its 200 years of existence by conventional medicine, this outbreak is a key opportunity to show potentially the contribution it can make in treating COVID-19 patients. This should be done through performance of impeccably controlled, prospective, randomized clinical trials, with publication of their findings in well-ranked conventional medicine journals. If the homeopathy community fails to take advantage of this rare opportunity, it might wait another century for the next major pandemic.

I must admit, I felt vaguely sick while reading it.

I was alerted to an interview published in an anthroposophical journal with Prof. Dr. med. Harald Matthes. He is the clinical director of the ‘Gemeinschaftskrankenhauses Havelhöhe‘, a hospital of anthroposophic medicine in Berlin where apparently some COVID-19 patients are presently being treated. Anthroposophic medicine is a medical cult created by the mystic, Rudolf Steiner, about 100 years ago that lacks a basis in science, facts or common sense. Here is the two passages from that interview that I find most interesting (my translation/explanation is below):

Es gibt bisher kein spezifisches Covid-19 Medikament aus der konventionellen Medizin. Remdesivir führt in Studien zu keinem signifikant verbesserten Überleben, sondern lediglich zu einer milden Symptomreduktion. Die anfänglich große Studie vor allem an Universitätskliniken mit Hydrochloroquin und Azithromycin erbrachte sogar eine Steigerung der Todesrate. Daher haben anthroposophische Therapiekonzepte mit Steigerung der Selbstheilungskräfte eine große Bedeutung erfahren. Wichtige anthroposophische Arzneimittel waren dabei das Eisen als Meteoreisen oder als Ferrum metallicum praep., der Phosphor, das Stibium sowie das Cardiodoron® und Pneumodoron®, aber auch Bryonia (Zaunrübe) und Tartarus stibiatus (Brechweinstein). Die Erfolge waren sehr gut, da in Havelhöhe bisher kein Covid-19 Patient verstorben ist, bei einer sonstigen Sterblichkeit von ca. 30% aller Covid-19-Intensivpatienten…

100 Jahre Bazillentheorie und die Dominanz eines pathogenetischen Medizinkonzeptes haben zu der von Rudolf Steiner bereits 1909 vorausgesagten Tyrannei im Sozialen geführt. Der Mensch hat ein Mikrobiom und Virom, das unverzichtbar für seine Immunität ist und von der Quantität mächtiger als der Mensch selbst (Mikrobiom 1014 Bakterien mit ca. 1200 Spezies z.B. im Darm bei nur 1012 Körperzellen).

Matthes explains that, so far, no medication has been demonstrated to be effective against COVID-19 infections. Then he continues: “This is the reason why anthroposophic therapies which increase the self-healing powers have gained great importance”, and names the treatments used in his hospital:

  • Meteoric Iron (a highly diluted anthroposophic remedy based on iron from meteors),
  • Ferrum metallicum praep. (a homeopathic/anthroposophic remedy based on iron),
  • Phosphor (a homeopathic remedy based on phosphor),
  • Stibium (a homeopathic remedy based on antimony),
  • Cardiodoron (a herbal mixture used in anthroposophical medicine),
  • Pneumodoron (a herbal mixture used in anthroposophical medicine containing).

Matthes also affirms (my translation):

“The success has so far been very good, since no COVID-19-patient has died in Havelhöhe – with a normal mortality of about 30% of COID_19 patients in intensive care…

100 years of germ theory and the dominance of a pathogenetic concept of medicine have led to the tyranny in the social sphere predicted by Rudolf Steiner as early as 1909. Humans have a microbiome and virom that is indispensable for their immunity and more powerful in quantity than humans themselves (microbiome 1014 bacteria with about 1200 species e.g. in the intestine with only 1012 somatic cells)…”

_________________

The first 4 remedies listed above are highly diluted and contain no active molecules. The last two are less diluted and might therefore contain a few active molecules but in sub-therapeutic doses. Crucially, none of the remedies have been shown to be effective for any condition.

The germ theory of disease which Matthes mentions is, of course, a bit more than a ‘theory’; it is the accepted scientific explanation for many diseases, including COVID-19.

I have cold sweats when I think of anthroposophical doctors who seem to take it less than seriously, while treating desperately ill COVID-19 patients. If I were allowed to ask just three questions to Matthes, I think, it would be these:

  1. How did you obtain fully informed consent from your patients, including the fact that your remedies are unproven and implausible?
  2. If you think your results are so good, are you monitoring them closely to publish them urgently, so that other centres might learn from them?
  3. Do you feel it is ethical to promote unprovn treatments during a health crisis via a publicly available interview before your results have been formally assessed and published?

Acupuncture-moxibustion therapy (AMT) is a so-called alternative medicine (SCAM) that has been used for centuries in treatment of numerous diseases. Some enthusiasts even seem to advocate it for chemotherapy-induced leukopenia (CIL)  The purpose of this review was to evaluate the efficacy and safety of acupuncture-moxibustion therapy in treating CIL.

Relevant studies were searched in 9 databases up to September 19, 2020. Two reviewers independently screened the studies for eligibility, extracted data, and assessed the methodological quality of selected studies. Meta-analysis of the pooled mean difference (MD) and risk ratio (RR) with their respective 95% confidence intervals (CI) were calculated.

Seventeen studies (1206 patients) were included, and the overall quality of the included studies was moderate. In comparison with medical therapy, AMT has a better clinical efficacy for CIL (RR, 1.24; 95% CI, 1.17-1.32; P < 0.00001) and presents advantages in increasing leukocyte count (MD, 1.10; 95% CI, 0.67-1.53; P < 0.00001). Also, the statistical results show that AMT performs better in improving the CIL patients’ Karnofsky performance score (MD, 5.92; 95% CI, 3.03-8.81; P < 0.00001).

The authors concluded that this systematic review and meta-analysis provides updated evidence that AMT is a safe and effective alternative for the patients who suffered from CIL.

A CIL is a serious complication. If I ever were afflicted by it, I would swiftly send any acupuncturist approaching my sickbed packing.

But this is not an evidence-based attitude!!!, I hear some TCM-fans mutter. What more do you want that a systematic review showing it works?

I beg to differ. Why? Because the ‘evidence’ is hardly what critical thinkers can accept as evidence. Have a look at the list of the primary studies included in this review:

  1. Lin Z. T., Wang Q., Yu Y. N., Lu J. S. Clinical observation of post-chemotherapy-leukopenia treated with ShenMai injectionon ST36. World Journal of Integrated Traditional and Western Medicine2010;5(10):873–876. []
  2. Wang H. Clinical Observation of Acupoint Moxibustion on Leukopenia Caused by Chemotherapy. Beijing, China: Beijing University of Chinese Medicine; 2011. []
  3. Fan J. Y. Coupling of Yin and Yang between Ginger Moxibustion Improve the Clinical Effect of the Treatment of Chemotherapy Adverse Reaction. Henan, China: Henan University of Chinese Medicine; 2013. []
  4. Lu D. R., Lu D. X., Wei M., et al. Acupoint injection with addie injection for patients of nausea and vomiting with cisplatin induced by chemotherapy. Journal of Clinical Acupuncture and Moxibustion2013;29(10):33–38. []
  5. Yang J. E. The Clinical Observation on Treatment of Leukopenia after Chemotherapy with Needle Warming Moxibustion. Hubei, China: Hubei University of Chinese Medicine; 2013. []
  6. Fu Y. H., Chi C. Y., Zhang C. Y. Clinical effect of acupuncture and moxibustion on leukopenia after chemotherapy of malignant tumor. Guide of China Medicine2014;12(12) []
  7. Wang J. N., Zhang W. X., Gu Q. H., Jiao J. P., Liu L., Wei P. K. Protection of herb-partitioned moxibustion on bone marrow suppression of gastric cancer patients in chemotherapy period. Chinese Archives of Traditional Chinese Medicine2014;32(12):110–113. []
  8. Zhang J. The Clinical Research on Myelosuppression and Quality of Life after Chemotherapy Treated by Grain-Sized Moxibustion. Nanjing, China: Nanjing University of Chinese Medicine; 2014. []
  9. Tian H., Lin H., Zhang L., Fan Z. N., Zhang Z. L. Effective research on treating leukopenia following chemotherapy by moxibustion. Clinical Journal of Chinese Medicine2015;7(10):35–38. []
  10. Hu G. W., Wang J. D., Zhao C. Y. Effect of acupuncture on the first WBC reduction after chemotherapy for breast cancer. Beijing Journal of Traditional Chinese Medicine2016;35(8):777–779. []
  11. Zhu D. L., Lu H. Y., Lu Y. Y., Wu L. J. Clinical observation of Qi-blood-supplementing needling for leukopenia after chemotherapy for breast cancer. Shanghai Journal of Acupuncture and Moxibustion2016;35(8):964–966. []
  12. Chen L, Xu G. Y. Observation on the prevention and treatment of chemotherapy-induced leukopenia by moxibustion therapy. Zhejiang Journal of Traditional Chinese Medicine2016;51(8):p. 600. []
  13. Mo T., Tian H., Yue S. B., Fan Z. N., Zhang Z. L. Clinical observation of acupoint moxibustion on leukocytopenia caused by tumor chemotherapy. World Chinese Medicine2016;11(10):2120–2122. []
  14. Nie C. M. Nursing observation of acupoint moxibustion in the treatment of leucopenia after chemotherapy. Today Nurse2017;4:93–95. []
  15. Wang D. Y. Clinical Research on Post-chemotherapy-leukopenia with Spleen-Kidney Yang Deficiency in Colorectal Cancer Treated with Point-Injection. Yunnan, China: Yunnan University of Chinese Medicine; 2017. []
  16. Gong Y. Q, Zhang M. Q, Zhang B. C. Prevention and treatment of leucocytopenia after chemotherapy in patients with malignant tumor with ginger partitioned moxibustion. Chinese Medicine Modern Distance Education of China2018;16(21):135–137. []
  17. Li Z. C., Lian M. J., Miao F. G. Clinical observation of fuzheng moxibustion combined with wenyang shengbai decoction in the treatment of 80 cases of leukopenia after chemotherapy. Hunan Journal of Traditional Chinese Medicine2019;35(3):64–66. []

Notice anything peculiar?

  • The studies are all from China where data fabrication was reported to be rife.
  • They are mostly unavailable for checking (why the published adds links that go nowhere is beyond me).
  • Many do not look at all like randomised clinical trials (which, according to the authors, was an inclusion criterion).
  • Many do not look as though their primary endpoint was the leukocyte count (which, according to the authors, was another inclusion criterion).

Intriguingly, the authors conclude that AMT is not just effective but also ‘safe’. How do they know? According to their own data extraction table, most studies failed to mention adverse effects. And how exactly is acupuncture supposed to increase my leukocyte count? Here is what the authors offer as a mode of action:

Based on the theory of traditional Chinese medicine (TCM), CIL belongs to the category of consumptive disease, owing to the exhaustion of genuine qi in the zang-fu viscera and the insufficiency of kidney essence and qi-blood. Researchers believe that there is an intimate association between the occurrence of malignant tumors and the deficiency of genuine qi. During attacking the cancer cells, chemotherapeutics also damaged the function of zang-fu viscera and qi-blood, leading to CIL. According to the theory of TCM and meridian, acupuncture-moxibustion is an ancient therapeutic modality that may be traced back more than 3500 years in China. Through meridian conduction, acupuncture-moxibustion therapy stimulates acupoints to strengthen the condition of zang-fu viscera and immune function, supporting genuine qi to improve symptoms of consumption.

I think it is high time that we stop tolerating that the medical literature gets polluted with such nonsense (helped, of course, by journals that are beyond the pale) – someone might actually believe it, in which case it would surely hasten the death of vulnerable patients.

Or perhaps not?
Here is the announcement:

Research by a reputable independent research company done for Securivita a German insurance company shows that those receiving homeopathic care were much better off. Over 15,700 patients were involved in the study which also used a comparison group.

The study showed that in a wide range of patients with various pathological problems that if they had homeopathic care they faired dramatically better than those just getting conventional medicine.

Children having homeopathy treatment from birth, were particularly healthier and with less problems. Over the three year study period, the number of children needing antibiotics decreased by 16.7 per cent in the homeopathy group, whereby it increased by 73.9 per cent in the conventional medical comparison group!

The number of hospitalizations in the comparison group increased by 32.6 per cent whereby in the homeopathy treatment group it decreased by 9.8 per cent!

Adults and children treated homoeopathically had dramatic improvements in allergies, dermatitis, asthma, just to name a few.

These are just a few examples of the remarkable benefits of homeopathic treatment outlined in the study by by the Leipzig Health Forum , an independent analytical institute specializing in health services conducted for Securvita Krankenkasse Insurer.

“We don’t need fewer, but more homeopathic doctors who will continue on this successful path,” says Götz Hachtmann , director of the health insurance company Securvita.

The study is in German and can be found here.

____________________________

Blessed are those who don’t read German (at least in this instance)!

As I am not amongst the blessed, I ought to tell you a bit about the ‘massive’ study. The OHR, the ‘OFFICIAL HOMEOPATHIC RESOURCE’ (btw what makes the OHR ‘official’?) claims that the study can be found here. The OHR is evidently not well enough resourced for translating the German text into English; if they were, they would know that the link goes not to a ‘study’ but to some kind of a glossy marketing brochure about the ‘study’ (there is no actual published scientific paper on the ‘study’). It provides hardly any relevant information; all we learn is that 15 700 individuals who regularly consulted homeopathic physicians were compared over a three year period to an equally sized control group who did not consult homeopathic doctors… And that’s essentially it! No further relevant details are offered.

By contrast, quite a bit of information is offered about the findings, for instance:

  • In the homeopathy group, the hospitalisation rate of depressive patients dropped by 10%, while it increased in controls by 33%.
  • The days off work dropped by 17% vs an increase in controls of 17%.
  • The use of antibiotics decreased by 17% vs an increase of 74%.

And how do they explain these differences?

Yes, you guessed it:

they are due to homeopathy!

One does not need to have a perfumer’s nose to smell a few badly decomposing rats here, for example:

  1. We do not learn how many variables were tested in this ‘study’. Therefore, it is likely that the ‘results’ provided are the positive ones, while the not so positive potential effects of homeopathy remained unmentioned. Perhaps the death rate was higher in the homeopathy group? Perhaps they suffered more heart attacks? Perhaps they had a lower quality of life? Perhaps they caused more costs? Perhaps they committed more suicides? etc. etc.
  2. Even more obvious is the stench of selection bias. The individuals in the homeopathy group were clearly different from the controls to start with. They might have been more health conscious. They clearly were more cautious about antibiotics. They might have been of better general health. They might have been younger. They could have contained more women. They might have been more afraid of going into a hospital. They might have been keener to attend work. In fact, the only variable in which the two groups were comparable is sample size.

Even if we eventually we see this ‘study’ published in a peer-reviewed journal with full methodological details etc., it will not allow even the smartest spin-doctor to establish cause and effect. Its findings would not be more conclusive than those of previously discussed attempts to produce positive evidence for homeopathy. The ‘positive’ findings could have been the result of hundreds of causes, none of which are related to homeopathy.

In a nutshell: this new German ‘study’ is a textbook example for arguing in favour of conducting proper research rather that rampant pseudo-research.

But I must not always be so negative!!!

So, let me try to point out the positive sides of this ‘study’:

The ‘massive independent study’ is a true masterpiece of advertising and marketing for both Securivita and homeopathy.

Well done guys!

I am proud of you!

  • That’s exactly the stuff needed for successfully misleading the public.
  • That’s precisely the info required to increase your cash flow.
  • That’s helpful ‘research’ for convincing politicians.
  • That’s definitely the type of baloney to impresses the Ullmanns of this world.
  • That’s even the sort of ‘science’ which the ‘OFFICIAL HOMEOPATHIC RESOURCE’ cannot recognise for what it truly is:

invalid junk.

This Cochrane review assessed the efficacy and safety of aromatherapy for people with dementia. The researchers  included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.

The investigators included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were:

  • lavender (eight studies);
  • lemon balm (four studies);
  • lavender and lemon balm,
  • lavender and orange,
  • cedar extracts (one study each).

For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66). The primary outcomes were:

  • agitation,
  • overall behavioural,
  • psychological symptoms,
  • adverse effects.

Ten trials assessed agitation using various scales. Among the 5 trials for which the confidence in the results was moderate or low, 4 trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other 5 trials either reported no useable data or the confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and there was moderate or low confidence in the results of 5 of them. Of these, 4 reported significant benefit from aromatherapy and one reported no significant effect.

Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. There was no evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. The confidence in the results of these studies was low.

The authors reached the following conclusions: We have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.

This is a thorough review. It makes many of the points that I so often make regarding SCAM research:

  • too many of the primary studies are badly designed;
  • too many of the primary studies are too small;
  • too many of the primary studies are poorly reported;
  • too many of the primary studies fail to mention adverse effects thus violating research ethics;
  • too many of the primary studies are done by pseudo-scientists who use research for promotion rather than testing hypotheses.

It is time that SCAM researchers, ethic review boards, funders, editors and journal reviewers take these points into serious consideration – if only to avoid clinical research getting a bad reputation and losing the support of patients without which it cannot exist.

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