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

pseudo-science

It is time, I think, to express my gratitude to Dr Jens Behnke, a German homeopath employed by the pro-homeopathy lobby group the ‘Carstens Stiftung’, who diligently tweets trials of homeopathy which he obviously believes prove the value of his convictions.

The primary objective of this new study was to evaluate the efficacy of homoeopathy for women suffering from polycystic ovary syndrome. This condition is characterised by:

  • irregular periods which means your ovaries don’t regularly release eggs,
  • abnormally high levels of male hormones in the body, which may cause physical signs such as excess facial or body hair,
  • polycystic ovaries – ovaries become enlarged and contain many fluid-filled sacs (follicles) which surround the eggs.

There’s no cure for PCOS, but the symptoms can usually be treated. As so often in such situations, homeopaths are happy to step into the fray.

This single-blind, randomised, placebo-controlled pilot study was conducted at two research centres in India. The cases fulfilling the eligibility criteria were enrolled (n = 60) and randomised to either the homoeopathic intervention (HI) (n = 30) or placebo (P) (n = 30) with uniform lifestyle modification (LSM) for 6 months.

The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18) in HI + LSM group and none (n = 0) in control group. Statistically significant difference was observed in the reduction of intermenstrual duration in HI + LSM in comparison to placebo + LSM group. Significant improvements were also observed in HI+LSM group in domains of weight, fertility, emotions and menstrual problems. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated homeopathic remedy.

The authors concluded that HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

This trial might convince believers (mostly because they do not even need convincing), but it cannot convince anybody capable of critical thinking. Here is why:

  • According to its authors, this trial was a pilot study; this means it should not report any results and merely focus on the feasibility of a definitive trial.
  • Researchers were not blinded, meaning that they might have influenced the outcome in more than one way.
  • The primary endpoint was subjective and could have been influenced by the non-blinded researchers.
  • 0% success rate in achieving the primary endpoint in the placebo group is not plausible.
  • Compliance to LSM was not checked; as the homeopathy group lost more weight, these patients seemed to have complied better (probably due to being better motivated by the non-blinded researchers).

So?

My conclusion is not very original but all the more true: POORLY DESIGNED STUDIES USUALLY GENERATE UNRELIABLE RESULTS. 

For some researchers, the question whether homeopathy works beyond a placebo effect is not as relevant as the question whether it works as well as an established treatment. To answer it, they must conduct RCTs comparing homeopathy with a therapy that has been shown beyond reasonable doubt to be effective, i.e better than placebo. Such a drug is, for instance, Ibuprofen.

The purpose of this study was to compare the efficacy of Ibuprofen and homeopathic Belladonna for orthodontic pain. 51 females and 21 males, were included in this study. Cases with non-extraction treatment plan having proper contacts’ mesial and distal to permanent first molar and currently not taking any analgesics or antibiotics were included in the study. They were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group took Belladonna 6C (that’s a dilution of 1: 1000000000000). Patients were given two doses of medication of their respective remedies one hour before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) and one dose 6 h after the placement. Pain scores were recorded on a visual analogue scale (VAS) 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning.

The comparisons showed that there were no differences between the two groups at any time point.

(Mean visual analogue scale pain score at different time intervals after separator placement in Ibuprofen and Belladonna group)

The authors concluded that Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.

FINALLY, THE PROOF HOMEOPATHS HAVE BEEN WAITING FOR: HOMEOPATHY DOES WORK AFTER ALL!

Not so fast – before we draw any conclusions, let’s have a closer look at this study. Here are a few of its limitations (apart from the fact that it was published in a journal that does not exactly belong to the ‘crème de la crème’ of medical publications):

  • Patients obviously knew which group they were assigned to; thus their expectations would have influenced the outcome.
  • The same applies to the researchers (the study could have been ‘blind’ using a ‘double dummy’ method, but the researchers did not use it).
  • The study was an equivalence trial (it did not test whether homeopathy is superior to placebo, but whether its effects are equivalent to Ibuprofen); such studies need sample sizes that are about one dimension larger than was the case here.

Therefore, all this trial does demonstrate that the sample was too small for an existing group difference in favour of Ibuprofen to show.

So sorry, my homeopathic friends!

Ginkgo biloba is a well-researched herbal medicine which has shown promise for a number of indications. But does this include coronary heart disease?

The aim of this systematic review was to provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection (GD) as one adjuvant therapy for treating angina pectoris (AP) and to evaluate the relevant randomized controlled trials (RCTs) with meta-analysis. (Ginkgo Leaf Extract and Dipyridamole Injection is a Chinese compound preparation, which consists of ginkgo flavone glycosides (24%), terpene lactones (ginkgolide about 13%, ginkgolide about 2.9%) and dipyridamole.)

RCTs concerning AP treated by GD were searched and the Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine (WM) against AP was associated with a higher total effective rate [risk ratio (RR)=1.25, 95% confidence interval (CI): 1.21–1.29, P<0.01], total effective rate of electrocardiogram (RR=1.29, 95% CI: 1.21–1.36, P<0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference (MD)=–0.56, 95% CI:–0,81 to–0.30, P<0.01], fibrinogen [MD=–1.02, 95% CI:–1.50 to–0.54, P<0.01], whole blood low shear viscosity [MD=–2.27, 95% CI:–3.04 to–1.49, P<0.01], and whole blood high shear viscosity (MD=–0.90, 95% CI: 1.37 to–0.44, P<0.01).

The authors concluded that comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.

If one reads this conclusion, one might be tempted to use GD to cure AP. I would, however, strongly warn everyone from doing so. There are many reasons for my caution:

  • All the 41 RCTs originate from China, and we have repeatedly discussed that Chinese TCM trials are highly unreliable.
  • The methodological quality of the primary RCTs was, according to the review authors ‘moderate’. This is not true; it was, in fact, lousy.
  • Dipyridamole is not indicated in angina pectoris.
  • To the best of my knowledge, there is no good evidence from outside China to suggest that Ginkgo biloba is effective for angina pectoris.
  • Angina pectoris is caused by coronary artery disease (a narrowing of one or more coronary arteries due to atherosclerosis), and it seems implausible that this condition can be ‘cured’ with any medication.

So, what we have here is yet another nonsensical paper, published in a dubious journal, employing evidently irresponsible reviewers, run by evidently irresponsible editors, hosted by a seemingly reputable publisher (Springer). This is reminiscent of my previous post (and many posts before). Alarmingly, it is also what I encounter on a daily basis when scanning the new publications in my field.

The effects of this incessant stream of nonsense can only have one of two effects:

  1. People take this ‘evidence’ seriously. In this case, many patients might pay with their lives for this collective incompetence.
  2. People conclude that alt med research cannot be taken seriously. In this case, we are unlikely to ever see anything useful emerging from it.

Either way, the result will be profoundly negative!

It is high time to stop this idiocy; but how?

I wish, I knew the answer.

Shiatsu has been mentioned here before (see for instance here, here and here). It is one of those alternative therapies for which a plethora of therapeutic claims are being made in the almost total absence of reliable evidence. This is why I am delighted each time a new study emerges.

This proof of concept study explored the feasibility of ‘hand self-shiatsu’ as an intervention to promote sleep onset and continuity for young adults with SRC. It employed a prospective case-series design, where participants, athletes who have suffered from concussion, act as their own controls. Baseline and follow-up data included standardized self-reported assessment tools and sleep actigraphy. Seven athletes, aged between 18 and 25 years, participated. Although statistically significant improvement in actigraphy sleep scores between baseline and follow-up was not achieved, metrics for sleep quality and daytime fatigue showed significant improvement.

The authors concluded from these data that these findings support the hypothesis that ‘hand self-shiatsu has the potential to improve sleep and reduce daytime fatigue in young postconcussion athletes. This pilot study provides guidance to refine research protocols and lays a foundation for further, large-sample, controlled studies.

How very disappointing! If this was truly meant to be a pilot study, it should not mention findings of clinical improvement at all. I suspect that the authors labelled it ‘a pilot study’ only when they realised that it was wholly inadequate. I also suspect that the study did not yield the result they had hoped for (a significant improvement in actigraphy sleep scores), and thus they included the metrics for sleep quality and daytime fatigue in the abstract.

In any case, even a pilot study of just 7 patients is hardly worth writing home about. And the remark that participants acted as their own controls is a new level of obfuscation: there were no controls, and the results are based on before/after comparisons. Thus none of the outcomes can be attributed to shiatsu; more likely, they are due to the natural history of the condition, placebo effects, concomitant treatments, social desirability etc.

What sort of journal publishes such drivel that can only have the effect of giving a bad name to clinical research? The Journal of Integrative Medicine (JIM) is a peer-reviewed journal sponsored by Shanghai Association of Integrative Medicine and Shanghai Changhai Hospital, China. It is a continuation of the Journal of Chinese Integrative Medicine (JCIM), which was established in 2003 and published in Chinese language. Since 2013, JIM has been published in English language. They state that the editorial board is committed to publishing high-quality papers on integrative medicine... I consider this as a bad joke! More likely, this journal is little more than an organ for popularising TCM propaganda in the West.

And which publisher hosts such a journal?

Elsevier

What a disgrace!

 

I have just been in Sao Paulo to give a lecture at the opening of a new university institute, ‘Question of Science‘. Under the leadership of Natalia Pasternak, the institute will promote scepticism in Brazil, particularly in the area of alternative medicine. Brazil currently has no less than 29 types of alternative medicine paid for with public money, and even homeopathy is officially being recognised and taught at all Brazilian medical schools.

But the most peculiar case of Brazilian quackery must surely be phosphoethanolamine. Gilberto Chierice, a Chemistry Professor at the University of São Paulo, used resources from a campus laboratory to unofficially manufacture, distribute, and promote the chemical to cancer patients claiming that it was a cheap cure for all cancers without side-effects. Remarkably, this was in the total absence of through clinical testing. In September 2015, university administrators therefore began preventing him from continuing with this practice. However, in October 2015, several courts in Brazil ruled in favour of plaintiffs who wanted the compound to remain available. In an unusual move of defence of common sense, a state court overturned the lower courts’ decision a month later, and the secretary for Brazil’s science and technology ministry promised to fund further research on the compound. In 2016, a law was passed in Brazil allowing the sale of synthetic phosphorylethanolamine for cancer treatment. Due to opposition from the Brazilian Medical Association, the Brazilian Society of Clinical Oncology, and the regulatory agency ANVISA, the country’s Supreme Court then suspended the law. I was told that a stepwise plan of clinical testing had been implemented. As the drug even failed to pass the most preliminary tests, the program had to be aborted.

This story seems like a re-play of many similar tales of bogus cancer cures of the past. They all seem to follow a similar pattern:

  1. Someone dreams up a ‘cure’ for all cancers that is cheap and free of side-effects.
  2. This appeals to many desperate cancer patients who are fighting for their lives.
  3. It also attracts several entrepreneurs who are hoping to make a fast buck.
  4. The story is picked up by the press and consequently a sizable grass-roots movement of support emerges.
  5. Populist politicians jump on the vote-winning band-waggon.
  6. The experts caution that the bogus cancer ‘cure’ is devoid of evidence and might put patients’ lives at risk.
  7. The legislators get involved.
  8. Law suits start left, right and centre.
  9. Eventually, the cancer ‘cure’ is scientifically tested and confirmed to be bogus.
  10. Eventually, the law rules against the bogus ‘cure’.
  11. A conspiracy theory emerges stating that the cancer ‘cure’ was unjustly suppressed to protect the interests of Big Pharma.
  12. A few years later, the subject re-surfaces and the whole cycle starts from the beginning.

Such stories remind us that fighting bogus claims is hugely important, even if it does not always succeed or turns out to be merely an exercise of damage limitation. Every life saved by the struggle against quackery makes it worthwhile.

I wish the new Institute ‘Question of Science‘ all the luck it richly deserves and desperately needs.

Professor Frass is well known to most people interested in homeopathy. He has also featured several times on this blog (see here, here and here). Frass has achieved what few homeopaths have: he has integrated homeopathy into a major medical school, the Medical School of the University of Vienna (my former faculty). In 2002, he started teaching homeopathy to medical students, and in 2004, he opened an out-patient clinic ‘Homeopathy for malignant diseases’ at the medical school.

This achievement was widely used for boosting the reputation of homeopathy; the often heard argument was that ‘homeopathy must be good and evidence-based, because a major medical school has adopted it’. This argument is now obsolete: Frass’ lectures have recently been axed!

How come?

Apparently, several students*** filed complaints with their dean about Frass’ lectures. This prompted the dean, Prof Mueller, to look into the matter and take drastic action. He is quoted stating that “the medical faculty rejects unscientific methods and quackery”.

Frass had repeatedly been seen on television claiming that homeopathy could be an effective adjuvant therapy for cancer, and that he had studies to prove it. Such statements had irritated Mueller who then instructed Frass in writing to abstain from such claims and to close his homeopathic out-patient clinic at the University. The matter was also brought to the attention of the University’s ethics committee which decided that Frass’ studies were not suited to provide a scientific proof.

Frass commented saying that he is not surprised about criticism because homeopathy is difficult to understand. He will retire next year from the University and will probably continue his homeopathic practice in a private setting.

(If you can read German, this article in the Austrian paper DER STANDARD has more details)

***as they had invited me to give a lecture on homeopathy some time ago, I like to think that I might have something to do with all this.

This systematic review was aimed at evaluating the effects of acupuncture on the quality of life of migraineurs.  Only randomized controlled trials that were published in Chinese and English were included. In total, 62 trials were included for the final analysis; 50 trials were from China, 3 from Brazil, 3 from Germany, 2 from Italy and the rest came from Iran, Israel, Australia and Sweden.

Acupuncture resulted in lower Visual Analog Scale scores than medication at 1 month after treatment and 1-3 months after treatment. Compared with sham acupuncture, acupuncture resulted in lower Visual Analog Scale scores at 1 month after treatment.

The authors concluded that acupuncture exhibits certain efficacy both in the treatment and prevention of migraines, which is superior to no treatment, sham acupuncture and medication. Further, acupuncture enhanced the quality of life more than did medication.

The authors comment in the discussion section that the overall quality of the evidence for most outcomes was of low to moderate quality. Reasons for diminished quality consist of the following: no mentioned or inadequate allocation concealment, great probability of reporting bias, study heterogeneity, sub-standard sample size, and dropout without analysis.

Further worrisome deficits are that only 14 of the 62 studies reported adverse effects (this means that 48 RCTs violated research ethics!) and that there was a high level of publication bias indicating that negative studies had remained unpublished. However, the most serious concern is the fact that 50 of the 62 trials originated from China, in my view. As I have often pointed out, such studies have to be categorised as highly unreliable.

In view of this multitude of serious problems, I feel that the conclusions of this review must be re-formulated:

Despite the fact that many RCTs have been published, the effect of acupuncture on the quality of life of migraineurs remains unproven.

 

I only recently came across this review; it was published a few years ago but is still highly relevant. It summarizes the evidence of controlled clinical studies of TCM for cancer.

The authors searched all the controlled clinical studies of TCM therapies for all kinds of cancers published in Chinese in four main Chinese electronic databases from their inception to November 2011. They found a total of 2964 reports (involving 253,434 cancer patients) including 2385 randomized controlled trials and 579 non-randomized controlled studies.

The top seven cancer types treated were lung cancer, liver cancer, stomach cancer, breast cancer, esophagus cancer, colorectal cancer and nasopharyngeal cancer by both study numbers and case numbers. The majority of studies (72%) applied TCM therapy combined with conventional treatment, whilst fewer (28%) applied only TCM therapy in the experimental groups. Herbal medicine was the most frequently applied TCM therapy (2677 studies, 90.32%). The most frequently reported outcome was clinical symptom improvement (1667 studies, 56.24%) followed by biomarker indices (1270 studies, 42.85%), quality of life (1129 studies, 38.09%), chemo/radiotherapy induced side effects (1094 studies, 36.91%), tumour size (869 studies, 29.32%) and safety (547 studies, 18.45%).

The authors concluded that data from controlled clinical studies of TCM therapies in cancer treatment is substantial, and different therapies are applied either as monotherapy or in combination with conventional medicine. Reporting of controlled clinical studies should be improved based on the CONSORT and TREND Statements in future. Further studies should address the most frequently used TCM therapy for common cancers and outcome measures should address survival, relapse/metastasis and quality of life.

This paper is important, in my view, predominantly because it exemplifies the problem with TCM research from China and with uncritical reviews on this subject. If a cancer patient, who does not know the background, reads this paper, (s)he might think that TCM is worth trying. This conclusion could easily shorten his/her life.

The often-shown fact is that TCM studies from China are not reliable. They are almost invariably positive, their methodological quality is low, and they are frequently based on fabricated data. In my view, it is irresponsible to publish a review that omits discussing these facts in detail and issuing a stark warning.

TCM FOR CANCER IS A VERY BAD CHOICE!

In the latest issue of ‘Simile’ (the Faculty of Homeopathy‘s newsletter), the following short article with the above title has been published. I took the liberty of copying it for you:

Members of the Faculty of Homeopathy practising in the UK have the opportunity to take part in a trial of a new homeopathic remedy for treating infant colic. An American manufacturer of homeopathic remedies has made a registration application for the new remedy to the MHRA (Medicines and Healthcare products Regulatory Agency) under the UK “National Rules” scheme. As part of its application the manufacturer is seeking at least two homeopathic doctors who would be willing to trial the product for about a year, then write a short report about using the remedy and its clinical results. If you would like to take part in the trial, further details can be obtained from …

END OF QUOTE

A homeopathic remedy for infant colic?

Yes, indeed!

The British Homeopathic Association and many similar ‘professional’ organisations recommend homeopathy for infant colic: Infantile colic is a common problem in babies, especially up to around sixteen weeks of age. It is characterised by incessant crying, often inconsolable, usually in the evenings and often through the night. Having excluded underlying pathology, the standard advice given by GPs and health visitors is winding technique, Infacol or Gripe Water. These measures are often ineffective but for­tunately there are a number of homeo­pathic medicines that may be effective. In my experience Colocynth is the most successful; alternatives are Carbo Veg, Chamomilla and Nux vomica.

SO, IT MUST BE GOOD!

But hold on, I cannot find a single clinical trial to suggest that homeopathy is effective for infant colic.

Ahhhhhhhhhhhhhhhhhhh, I see, that’s why they now want to conduct a trial!

They want to do the right thing and do some science to see whether their claims are supported by evidence.

How very laudable!

After all, the members of the Faculty of Homeopathy are doctors; they have certain ethical standards!

After all, the Faculty of Homeopathy aims to provide a high level of service to members and members of the public at all times.

Judging from the short text about the ‘homeopathy for infant colic trial’, it will involve a few (at least two) homeopaths prescribing the homeopathic remedy to patients and then writing a report. These reports will unanimously state that, after the remedy had been administered, the symptoms improved considerably. (I know this because they always do improve – with or without treatment.)

These reports will then be put together – perhaps we should call this a meta-analysis? – and the overall finding will be nice, positive and helpful for the American company.

And now, we all understand what homeopaths, more precisely the Faculty of Homeopathy, consider to be evidence.

 

 

A survey was commissioned in 2015 to obtain general population figures for practitioner-led CAM use in England, and to discover people’s views and experiences regarding access.

Of 4862 adults surveyed, 766 (16%) had seen a CAM practitioner. People most commonly visited CAM practitioners for manual therapies (massage, osteopathy, chiropractic) and acupuncture, as well as yoga, pilates, reflexology, and mindfulness or meditation. Women, people with higher socioeconomic status (SES) and those in south England were more likely to access CAM. Musculoskeletal conditions (mainly back pain) accounted for 68% of use, and mental health 12%. Most was through self-referral (70%) and self-financing. GPs (17%) or NHS professionals (4%) referred and/or recommended CAM to users. These CAM users were more often unemployed, with lower income and social grade, and receiving NHS-funded CAM. Responders were willing to pay varying amounts for CAM; 22% would not pay anything. Almost two in five responders felt NHS funding and GP referral and/or endorsement would increase their CAM use.

The authors concluded that CAM use in England is common for musculoskeletal and mental health problems, but varies by sex, geography, and SES. It is mainly self-referred and self-financed; some is GP-endorsed and/or referred, especially for individuals of lower SES. Researchers, patients, and commissioners should collaborate to research the effectiveness and cost-effectiveness of CAM and consider its availability on the NHS.

The table below shows the percentage figures for specific CAMs (right column).

Type of CAM practitioner n %
Massage practitioner 143 19
Osteopath 91 12
Acupuncturist 88 11
Chiropractor 87 11
Yoga teacher 52 7
Physiotherapist-delivered CAM 41 5
Pilates teacher 28 4
Reflexologist 22 3
Meditation and/or mindfulness teacher 20 3
Homeopath 20 3
Reiki practitioner 17 2
Hypnotherapist 15 2
Herbalist 14 2
Chinese herbal medical practitioner 12 2
Other 74 10

Our own survey suggested that, in 2005, the 1-year prevalence of CAM-use in England was 26.3 % and the practitioner-led CAM-use was 12.1 %. The two surveys are, however, not comparable because they did use different methodologies; for instance, they included different types of CAM. I therefore think that any conclusion of an increase in practitioner-led CAM-use between 2005 and 2015 is not warranted. It also follows that the graphic below is misleading.

In the discussion, the authors of the new survey make the following point: Ability to pay may be a factor in accessing CAM (indicated by the association of CAM use with higher SES; lower SES responders being more likely to be GP-referred to CAM; and responders stating that they may use more CAM if the NHS provided services, and GPs endorsed and/or referred them). Integration of CAM into the NHS through primary care could promote continuity of care, safety, and balance of power. An integrative medicine approach includes many of the values recently included in UK health policy documents; for example, Five Year Forward View. It is patient-centred, as discussed in 2010, focuses on prevention, and emphasises patient self-management and person- and community-centred approaches to health and wellbeing. Many of these values underpin social prescribing, which is an increasingly popular model of health care. There seems to be significant patient demand for CAM and more holistic approaches, and a view that CAM may improve patient satisfaction.

I have in a previous post commented on prevalence surveys: the argument that is all too often spun around such survey data goes roughly as follows: a large percentage of the population uses alternative medicine; people pay out of their own pocket for these treatments; they are satisfied with them (if not, they would not pay for them). BUT THIS IS GROSSLY UNFAIR! Why should only those individuals who are rich enough to afford alternative medicine benefit from it? ALTERNATIVE MEDICINE SHOULD BE MADE AVAILABLE FOR ALL.

To me, it is obvious that this line of argument is dangerously wrong. It lends itself to the promotion of unproven therapies to the detriment of good healthcare and progress. Sadly, I fear that the new survey is going to be misused in this way.

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