MD, PhD, FMedSci, FSB, FRCP, FRCPEd

critical thinking

Guest post by Nick Ross

If you’re a fan of Edzard Ernst – and who with a rational mind would not be – then you will be a fan of HealthWatch.

Edzard is a distinguished supporter. Do join us. I can’t promise much in return except that you will be part of a small and noble organisation that campaigns for treatments that work – in other words for evidence based medicine. Oh, and you get a regular Newsletter, which is actually rather good.

HealthWatch was inspired 25 years ago by Professor Michael Baum, the breast cancer surgeon who was incandescent that so many women presented to his clinic late, doomed and with suppurating sores, because they had been persuaded to try ‘alternative treatment’ rather than the real thing.

But like Edzard (and indeed like Michael Baum), HealthWatch keeps an open mind. If there are reliable data to show that an apparently weirdo treatment works, hallelujah. If there is evidence that an orthodox one doesn’t then it deserves a raspberry. HealthWatch has worked to expose quacks and swindlers and to get the Advertising Standards Authority to do its job regulating against false claims and flimflam. It has fought the NHS to have women given fair and balanced advice about the perils of mass screening. It has campaigned with Sense About Science, English Pen and Index to protect whistleblowing scientists from vexatious libel laws, and it has joined the AllTrials battle for transparency in drug trials. It has an annual competition for medical and nursing students to encourage critical analysis of clinical research protocols, and it stages the annual HealthWatch Award and Lecture which has featured Edzard (in 2005) and a galaxy of other champions of scepticism and good evidence including Sir Iain Chalmers, Richard Smith, David Colquhoun, Tim Harford, John Diamond, Richard Doll, Peter Wilmshurst, Ray Tallis, Ben Goldacre, Fiona Godlee and, last year, Simon Singh. We are shortly to sponsor a national debate on Lord Saatchi’s controversial Medical innovation Bill.

But we need new blood. Do please check us out. Be careful, because since we first registered our name a host of brazen copycats have emerged, not least Her Majesty’s Government with ‘Healthwatch England’ which is part of the Care Quality Commission. We have had to put ‘uk’ at the end of our web address to retain our identity. So take the link to http://www.healthwatch-uk.org/, or better still take out a (very modestly priced) subscription.

As Edmund Burke might well have said, all it takes for quackery to flourish is that good men and women do nothing.

I would have never thought that someone would be able to identify the author of the text I quoted in the previous post:

It is known that not just novel therapies but also traditional ones, such as homeopathy, suffer opposition and rejection by some doctors without having ever been subjected to serious tests. The doctor is in charge of medical treatment; he is thus responsible foremost for making sure all knowledge and all methods are employed for the benefit of public health…I ask the medical profession to consider even previously excluded therapies with an open mind. It is necessary that an unbiased evaluation takes place, not just of the theories but also of the clinical effectiveness of alternative medicine.

More often than once has science, when it relied on theory alone, arrived at verdicts which later had to be overturned – frequently this occurred only after long periods of time, after progress had been hindered and most acclaimed pioneers had suffered serious injustice. I do not need to remind you of the doctor who, more than 100 years ago, in fighting puerperal fever, discovered sepsis and asepsis but was laughed at and ousted by his colleagues throughout his lifetime. Yet nobody would today deny that this knowledge is most relevant to medicine and that it belongs to the basis of medicine. Insightful doctors, some of whom famous, have, during the recent years, spoken openly about the crisis in medicine and the dead end that health care has maneuvered itself into. It seems obvious that the solution is going in directions which embrace nature. Hardly any other form of science is so tightly bound to nature as is the science occupied with healing living creatures. The demand for holism is getting stronger and stronger, a general demand which has already been fruitful on the political level. For medicine, the challenge is to treat more than previously by influencing the whole organism when we aim to heal a diseased organ.

It is from the opening speech by Rudolf Hess on the occasion of the WORLD CONFERENCE ON HOMEOPATHY 1937, in Berlin. Hess, at the time Hitler’s deputy, was not the only Nazi-leader. I knew of the opening speech because, a few years ago, DER SPIEGEL published a theme issue on homeopathy, and they published a photo of the opening ceremony of this meeting. It shows many men in SS-uniform and, in the first row of the auditorium, we see Hess (as well as Himmler) ready to spring into action.

Hess in particular was besotted with alternative medicine which the Nazis elected to call NEUE DEUTSCHE HEILKUNDE. Somewhat to the dismay of today’s alternative medicine enthusiasts, I have repeatedly published on this aspect of alternative medicine’s past, and it also is an important part of my new book A SCIENTIST IN WONDERLAND which the lucky winner (my congratulations!) of my little competition to identify the author has won. The abstract of an 2001 article explains this history succinctly:

The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930 this had led to a situation where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker’ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.

One fascinating aspect of this past is the fact that the NEUE DEUTSCHE HEILKUNDE was de facto the invention of what we today call ‘integrated medicine’. Then it was more like a ‘shot-gun marriage’, while today it seems to be driven more by political correctness and sloppy thinking. It did not work 70 years ago for the same reason that it will fail today: the integration of bogus (non-evidence based) treatments into conventional medicine must inevitably render health care not better but worse!

One does not need to be a rocket scientist to understand that, and Hess as well as other proponents of alternative medicine of his time had certainly got the idea. So they initiated the largest ever series of scientific tests of homeopathy. This research program was not just left to the homeopaths, who never had a reputation of being either rigorous or unbiased, but some of the best scientists of the era were recruited for it. The results vanished in the hands of the homeopaths during the turmoil of the war. But one eye-witness report of a homeopaths, Fritz Donner, makes it very clear: as it turned out, there was not a jot of evidence in favour of homeopathy.

And this, I think, is the other fascinating aspect of the story: homeopaths did not give up their plight to popularise homeopathy. On the contrary, they re-doubled their efforts to fool us all and to convince us with dodgy results (see recent posts on this blog) that homeopathy somehow does defy the laws of nature and is, in effect, very effective for all sorts of diseases.

My readers suggested all sorts of potential authors for the Hess speech; and they are right! It could have been written by any proponent of alternative medicine. This fact is amusing and depressing at the same time. Amusing because it discloses the lack of new ideas and arguments (even the same fallacies are being used). Depressing because it suggests that progress in alternative medicine is almost totally absent.

The very first article on a subject related to alternative medicine with a 2015 date that I came across is a case-report. I am afraid it will not delight our chiropractic friends who tend to deny that their main therapy can cause serious problems.

In this paper, US doctors tell the story of a young woman who developed headache, vomiting, diplopia, dizziness, and ataxia following a neck manipulation by her chiropractor. A computed tomography scan of the head was ordered and it revealed an infarct in the inferior half of the left cerebellar hemisphere and compression of the fourth ventricle causing moderately severe, acute obstructive hydrocephalus. Magnetic resonance angiography showed severe narrowing and low flow in the intracranial segment of the left distal vertebral artery. The patient was treated with mannitol and a ventriculostomy. Following these interventions, she made an excellent functional recovery.

The authors of the case-report draw the following conclusions: This report illustrates the potential hazards associated with neck trauma, including chiropractic manipulation. The vertebral arteries are at risk for aneurysm formation and/or dissection, which can cause acute stroke.

I can already hear the counter-arguments: this is not evidence, it’s an anecdote; the evidence from the Cassidy study shows there is no such risk!

Indeed the Cassidy study concluded that vertebral artery accident (VBA) stroke is a very rare event in the population. The increased risks of VBA stroke associated with chiropractic and primary care physician visits is likely due to patients with headache and neck pain from VBA dissection seeking care before their stroke. We found no evidence of excess risk of VBA stroke associated chiropractic care compared to primary care. That, of course, was what chiropractors longed to hear (and it is the main basis for their denial of risk) – so much so that Cassidy et al published the same results a second time (most experts feel that this is a violation of publication ethics).

But repeating arguments does not make them more true. What we should not forget is that the Cassidy study was but one of several case-control studies investigating this subject. And the totality of all such studies does not deny an association between neck manipulation and stroke.

Much more important is the fact that a re-analysis of the Cassidy data found that prior studies grossly misclassified cases of cervical dissection and mistakenly dismissed a causal association with manipulation. The authors of this new paper found a classification error of cases by Cassidy et al and they re-analysed the Cassidy data, which reported no association between spinal manipulation and cervical artery dissection (odds ratio [OR] 5 1.12, 95% CI .77-1.63). These re-calculated results reveal an odds ratio of 2.15 (95% CI.98-4.69). For patients less than 45 years of age, the OR was 6.91 (95% CI 2.59-13.74). The authors of the re-analysis conclude as follows: If our estimates of case misclassification are applicable outside the VA population, ORs for the association between SMT exposure and CAD are likely to be higher than those reported using the Rothwell/Cassidy strategy, particularly among younger populations. Future epidemiologic studies of this association should prioritize the accurate classification of cases and SMT exposure.
I think they are correct; but my conclusion of all this would be more pragmatic and much simpler: UNTIL WE HAVE CONVINCING EVIDENCE TO THE CONTRARY, WE HAVE TO ASSUME THAT CHIROPRACTIC NECK MANIPULATION CAN CAUSE A STROKE.

Moxibustion is an ancient variation of acupuncture using  moxa made from dried mugwort (Artemisia argyi). It has long played an important role in the traditional heath care systems of China and other Asian countries. More recently, it has become popular also in the West. Practitioners use moxa sticks indirectly to warm acupuncture needles, or burn it close to the patient’s skin. Essentially, moxibustion is a treatment where acupuncture points are stimulated mainly or exclusively by the heat of burning moxa.

Because of moxibustion’s long history of usage and the fact that it is employed in many countries for a very wide range of conditions, some might argue that it has stood the ‘test of time’ and should be considered to be a well-established therapy. More critical thinkers would, however, point out that this is not an argument but a classical fallacy.

My team at Exeter regularly had research fellows from Korea and other Asian countries, and we managed to develop a truly productive cooperation. It enabled us to conduct systematic reviews including the Asian literature – and this is how we got involved in an unusual amount of research into moxibustion which, after all, is a fairly exotic alternative therapy. In 2010, we began a series of systematic reviews of moxibustion.

One of the first such articles included 9 RCTs testing the effectiveness of this treatment for stroke rehabilitation. Three RCTs reported favorable effects of moxibustion plus standard care on motor function versus standard care alone Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion.

Also in 2010, our systematic review of RCTs of moxibustion as a treatment of ulcerative colitis (UC) concluded that current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.

Our (2010) systematic review od RCTs of moxibustion as a therapy in cancer care found that the evidence was limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies had a high risk of bias so effectively there was not enough evidence to draw any conclusion.

Our (2010) systematic review of RCTs of moxibustion for treating hypertension concluded that there was insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.

Our (2010) systematic review of RCTs of moxibustion for constipation concluded as follows: Given that the methodological quality of all RCTs was poor, the results from the present review are insufficient to suggest that moxibustion is an effective treatment for constipation. More rigorous studies are warranted.

Our (2010) systematic review found few RCTs were available that test the effectiveness of moxibustion in the management of pain, and most of the existing trials had a high risk of bias. Therefore, more rigorous studies are required before the effectiveness of moxibustion for the treatment of pain can be determined.

Our (2011) systematic review of 14 RCTs of moxibustion for rheumatic conditions failed to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions.

The, so far, last article in this series has only just been published. The purpose of this systematic review was to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included, if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias.

Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts.

Our conclusion: there is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.

Was all this research for nothing?

I know many people who would think so. However, I disagree. If nothing else, these articles demonstrated several facts quite clearly:

  • There is quite a bit of research even on the most exotic alternative therapy; sometimes one needs to look hard and include languages other than English.
  • Studies from China and other Asian counties very rarely report negative results; this fact casts a dark shadow on the credibility of such data.
  • The poor quality of trials in most areas of alternative medicine is lamentable and must be stimulus for researchers in this field to improve their act.
  • Authors of systematic reviews must resist the temptation to draw positive conclusions based on flawed primary data.
  • Moxibustion is a perfect example for demonstrating that the ‘test of time’ is no substitute for evidence.
  • As for moxibustion, it cannot currently be considered an evidence-based treatment for any condition.

As promised, I will try with this post to explain my reservations regarding the new meta-analysis suggesting that individualised homeopathic remedies are superior to placebos. Before I start, however, I want to thank all those who have commented on various issues; it is well worth reading the numerous and diverse comments.

To remind us of the actual meta-analysis, it might be useful to re-publish its abstract (the full article is also available online):

BACKGROUND:

A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos.

METHODS:

The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

RESULTS:

Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

CONCLUSIONS:

Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

Since my team had published an RCTs of individualised homeopathy, it seems only natural that my interest focussed on why the study (even though identified by Mathie et al) had not been included in the meta-analysis. Our study had provided no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.

I was convinced that this trial had been rigorous and thus puzzled why, despite receiving ‘full marks’ from the reviewers, they had not included it in their meta-analysis. I thus wrote to Mathie, the lead author of the meta-analysis, and he explained: For your trial (White et al. 2003), under domain V of assessment, we were unable to extract data for meta-analysis, and so it was attributed high risk of bias, as specified by the Cochrane judgmental criteria. Our designated main outcome was the CAQ, for which we needed to know (or could at least estimate) a mean and SD for both the baseline and the end-point of the study. Since your paper reported only the change from baseline in Table 3 or in the main text, it is not possible to derive the necessary end-point for analysis.

It took a while and several further emails until I understood: our study did report both the primary (Table 2 quality of life) and secondary outcome measure (Table 3 severity of symptoms). The primary outcome measure was reported in full detail such that a meta-analysis would have been possible. The secondary outcome measure was also reported but not in full detail, and the data provided by us would not lend themselves to meta-analyses. By electing not our primary but our secondary outcome measure for their meta-analysis, Mathie et al were able to claim that they were unable to use our study and reject it for their meta-analysis.

Why did they do that?

The answer is simple: in their methods section, they specify that they used outcome measures “based on a pre-specified hierarchical list in order of greatest to least importance, recommended by the WHO“. This, I would argue is deeply flawed: the most important outcome measure of a study is usually the one for which the study was designed, not the one that some guys at the WHO feel might be important (incidentally, the WHO list was never meant to be applied to meta-analyses in that way).

By following rigidly their published protocol, the authors of the meta-analysis managed to exclude our negative trial. Thus they did everything right – or did they?

Well, I think they committed several serious mistakes.

  • Firstly, they wrote the protocol, which forced them to exclude our study. Following a protocol is not a virtue in itself; if the protocol is nonsensical it even is the opposite. Had they proceeded as is normal in such cases and used our primary outcome measure in their meta-analyses, it is most likely that their overall results would not have been in favour of homeopathy.
  • Secondly, they awarded our study a malus point for the criterium ‘selective outcome reporting’. This is clearly a wrong decision: we did report the severity-outcome, albeit not in sufficient detail for their meta-analysis. Had they not committed this misjudgment, our RCT would have been the only one with an ‘A’ rating. This would have very clearly highlighted the nonsense of excluding the best-rated trial from meta-analysis.

There are several other oddities as well. For instance, Mathie et al judge our study to be NOT free of vested interest. I asked Mathie why they had done this and was told it is because we accepted free trial medication from a homeopathic pharmacy. I would argue that my team was far less plagued by vested interest than the authors of their three best (and of course positive) trials who, as I happen to know, are consultants for homeopathic manufacturers.

And all of this is just in relation to our own study. Norbert Aust has uncovered similar irregularities with other trials and I take the liberty of quoting his comments posted previously again here:

I have reason to believe that this review and metaanalysis in biased in favor of homeopathy. To check this, I compared two studies (1) Jacobs 1994 about the treatment of childhood diarrhea in Nicaragua, (2) Walach 1997 about homeopathic threatment of headaches. The Jacobs study is one of the three that provided ‘reliable evidence’, Walach’s study earned a poor C2.2 rating and was not included in the meta-analyses. Jacobs’ results were in favour of homeopathy, Walach’s not.

For the domains where the rating of Walach’s study was less than that of the Jacobs study, please find citations from the original studies or my short summaries for the point in question.

Domain I: Sequence generation:
Walach:
“The remedy selected was then mailed to a notary public who held a stock of placebos. The notary threw a dice and mailed either the homeopathic remedy or an appropriate placebo. The notary was provided with a blank randomisation list.”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“For each of these medications, there was a box of tubes in sequentially numbered order which had been previously randomized into treatment or control medication using a random numbers table in blocks of four”
Rating: YES (Low risk of bias)

Domain IIIb: Blinding of outcome assessor
Walach:
“The notary was provided with a blank randomization list which was an absolutely unique document. It was only handed out after the biometrician (WG) had deposited all coded original data as a printout at the notary’s office. (…) Data entry was performed blindly by personnel not involved in the study. ”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“All statistical analyses were done before breaking the randomisation code, using the program …”
Rating: YES (Low risk of bias)

Domain V: Selective outcome reporting

Walach:
Study protocol was published in 1991 prior to enrollment of participants, all primary outcome variables were reported with respect to all participants and the endpoints.
Rating: NO (high risk of bias)

Jacobs:
No prior publication of protocol, but a pilot study exists. However this was published in 1993 only after the trial was performed in 1991. Primary outcome defined (duration of diarrhea), reported but table and graph do not match, secondary outcome (number of unformed stools on day 3) seems defined post hoc, for this is the only one point in time, this outcome yielded a significant result.
Rating: YES (low risk of bias)

Domain VI: Other sources of bias:

Walach:
Rating: NO (high risk of bias), no details given

Jacobs:
Imbalance of group properties (size, weight and age of children), that might have some impact on course of disease, high impact of parallel therapy (rehydration) by far exceeding effect size of homeopathic treatment
Rating: YES (low risk of bias), no details given

In a nutshell: I fail to see the basis for the different ratings in the studies themselves. I assume bias of the authors of the review.

Conclusion

So, what about the question posed in the title of this article? The meta-analysis is clearly not a ‘proof of concept’. But is it proof for misconduct? I asked Mathie and he answered as follows: No, your statement does not reflect the situation at all. As for each and every paper, we selected the main outcome measure for your trial using the objective WHO classification approach (in which quality of life is clearly of lower rank than severity). This is all clearly described in our prospective protocol. Under no circumstances did we approach this matter retrospectively, in the way you are implying. 

Some nasty sceptics might have assumed that the handful of rigorous studies with negative results were well-known to most researchers of homeopathy. In this situation, it would have been hugely tempting to write the protocol such that these studies must be excluded. I am thrilled to be told that the authors of the current new meta-analysis (who declared all sorts of vested interests at the end of the article) resisted this temptation.

On this blog and elsewhere, I have repeatedly cast doubt on the efficacy of homeopathy – not because I have ‘an axe to grind’, as some seem to believe, but because

  1. the assumptions which underpin homeopathy fly in the face of science,
  2. the clinical evidence fails to show that it works beyond a placebo effect.

But was I correct?

A new systematic review and meta-analysis seems to indicate that I was mistaken. It tested the hypothesis that the outcome of an individualised homeopathic treatment (homeopaths would argue that this is the only true approach to homeopathy) is distinguishable from that with placebos.

The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

The authors arrived at the following conclusion: medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

One does not need to be a prophet to predict that the world of homeopathy will declare this article as the ultimate proof of homeopathy’s efficacy beyond placebo. Already the ‘British Homeopathic Association’ has issued the following press release:

Clinical evidence for homeopathy published

Research into the effectiveness of homeopathy as an individualised treatment has produced results that may surprise many from the worlds of science and medicine. The conclusions are reported cautiously, but the new publication is the first of its type to present evidence that medicines prescribed in individualised homeopathy may have specific effects.

The paper, published in the peer-reviewed journal Systematic Reviews,1 reports a rigorous systematic review and meta-analysis of 32 randomised controlled trials (RCTs) in which homeopathic medicines were prescribed on an individual basis to each participant, depending on their particular symptoms.

The overall quality of the RCT evidence was found to be low or unclear, preventing the researchers from reaching decisive conclusions. Three RCTs were identified as “reliable evidence”.

The study was led by Dr Robert Mathie, research development adviser for the British Homeopathic Association, in partnership with a number of collaborators, including colleagues at the Robertson Centre for Biostatistics, University of Glasgow, who independently verified the statistical methods and findings.

“What we found from the statistics,” says Dr Mathie, “is that the effect of individualised treatment using homeopathic medicines was significantly greater than placebos, and that this effect was retained when we included only the three trials with reliable evidence. This tentatively provides proof of concept that homeopathic medicines have clinical treatment effects.”

Surprised? I was stunned and thus studied the article in much detail (luckily the full text version is available online). Then I entered into an email exchange with the first author who I happen to know personally (to his credit, he responded regularly). In the end, this conversation helped me to better understand the review’s methodology; but it also resulted in me being very much underwhelmed by the reliability of the authors’ conclusion.

Normally I would now explain why. But, in this particular case, I thought it would be interesting and helpful to give others the opportunity to examine the article and come up with their own comments. Subsequently I will add my criticisms.

SO PLEASE TAKE SOME TIME TO STUDY THIS PAPER AND TELL US WHAT YOU THINK.

Each year, during the Christmas period, we are bombarded with religious ideology, soapy sentimentality and delusive festive cheer. In case you are beginning to feel slightly nauseous about all this, it might be time to counter-balance this abundance with my (not entirely serious) version of the ’10 commandments of quackery’?

  1. You must not use therapies other than those recommended by your healer – certainly nothing that is evidence-based!
  2. You must never doubt what your healer tells you; (s)he embraces the wisdom of millennia combined with the deep insights of post-modernism – and is therefore beyond doubt.
  3. You must happily purchase all the books, gadgets, supplements etc. your healer offers for sale. For more merchandise, you must frequent your local health food shops. Money is no object!
  4. You must never read scientific literature; it is the writing of evil. The truth can only be found by studying the texts recommended by your healer.
  5. You must never enter into discussions with sceptics or other critical thinkers; they are wicked and want to destroy your well-being.
  6. You must do everything in your power to fight the establishment, Big Pharma, their dangerous drugs and vicious vaccines.
  7. You must support Steiner Schools, Prince Charles and other enlightened visionaries so that the next generation is guided towards the eternal light.
  8. You must detox regularly to eliminate the ubiquitous, malignant poisons of Satan.
  9. You must blindly, unreservedly and religiously believe in vitalism, quantum medicine, vibrational energy and all other concepts your healer relies upon.
  10. You must denounce, vilify, aggress and attack anyone who disagrees with the gospel of your healer.

The regular consumption of fish-oil has a potentially favourable role in inflammation, carcinogenesis inhibition and cancer outcomes. An analysis of the literature aimed to review the evidence for the roles of dietary-fish and fish-oil intake in prostate-cancer (PC) risk, aggressiveness and mortality.

A systematic-review, following PRISMA guidelines was conducted. PubMed, MEDLINE and Embase were searched to explore PC-risk, aggressiveness and mortality associated with dietary-fish and fish-oil intake. 37 studies were selected.

A total of 37-studies with 495,321 participants were analysed. They revealed various relationships regarding PC-risk (n = 31), aggressiveness (n = 8) and mortality (n = 3). Overall, 10 studies considering PC-risk found significant inverse trends with fish and fish-oil intake. One found a dose–response relationship whereas greater intake of long-chain-polyunsaturated fatty acids increased risk of PC when considering crude odds-ratios [OR: 1.36 (95% CI: 0.99–1.86); p = 0.014]. Three studies addressing aggressiveness identified significant positive relationships with reduced risk of aggressive cancer when considering the greatest intake of total fish [OR 0.56 (95% CI 0.37–0.86)], dark fish and shellfish-meat (p < 0.0001), EPA (p = 0.03) and DHA (p = 0.04). Three studies investigating fish consumption and PC-mortality identified a significantly reduced risk. Multivariate-OR (95% CI) were 0.9 (0.6–1.7), 0.12 (0.05–0.32) and 0.52 (0.30–0.91) at highest fish intakes.

The authors concluded that fish and fish-oil do not show consistent roles in reducing PC incidence, aggressiveness and mortality. Results suggest that the specific fish type and the fish-oil ratio must be considered. Findings suggest the need for large intervention randomised placebo-controlled trials.

Several other recent reviews have also generated encouraging evidence, e.g.:

Available evidence is suggestive, but currently inadequate, to support the hypothesis that n-3 PUFAs protect against skin malignancy.

…omega-3 fatty acids may exert their anticancer actions by influencing multiple targets implicated in various stages of cancer development, including cell proliferation, cell survival, angiogenesis, inflammation, metastasis and epigenetic abnormalities that are crucial to the onset and progression of cancer.

If I was aiming for a career as a cancer quack, I would now use this evidence to promote my very own cancer prevention and treatment diet. As I have no such ambitions, I should tell you that regular fish oil consumption is no way to treat cancer. It also is no way to prevent cancer. If anything, it might turn out to be a way of slightly reducing the risk of certain cancers. To be sure, we need a lot more research, and once we have it, fish oil will be entirely mainstream. Raising false hopes regarding ‘alternative cancer cures’ based on fairly preliminary evidence is counter-productive, unethical and irresponsible.

Guest post by Pete Attkins

Commentator “jm” asked a profound and pertinent question: “What DOES it take for people to get real in this world, practice some common sense, and pay attention to what’s going on with themselves?” This question was asked in the context of asserting that personal experience always trumps the results of large-scale scientific experiments; and asserting that alt-med experts are better able to provide individulized healthcare than 21st Century orthodox medicine.

What does common sense and paying attention lead us to conclude about the following? We test a six-sided die for bias by rolling it 100 times. The number 1 occurs only once and the number 6 occurs many times, never on its own, but in several groups of consecutive sixes.

I think it is reasonable to say that common sense would, and should, lead everyone to conclude that the die is biased and not fit for its purpose as a source of random numbers.

In other words, we have a gut feeling that the die is untrustworthy. Gut instincts and common sense are geared towards maximizing our chances of survival in our complex and unpredictable world — these are innate and learnt behaviours that have enabled humans to survive despite the harshness of our ever changing habitat.

Only very recently in the long history of our species have we developed specialized tools that enable us to better understand our harsh and complex world: science and critical thinking. These tools are difficult to master because they still haven’t been incorporated into our primary and secondary formal education systems.

The vast majority of people do not have these skills therefore, when a scientific finding flies in the face of our gut instincts and/or common sense, it creates an overwhelming desire to reject the finding and classify the scientist(s) as being irrational and lacking basic common sense. It does not create an intense desire to accept the finding then painstakingly learn all of the science that went into producing the finding.

With that in mind, let’s rethink our common sense conclusion that the six-sided die is biased and untrustworthy. What we really mean is that the results have given all of us good reason to be highly suspicious of this die. We aren’t 100% certain that this die is biased, but our gut feeling and common sense are more than adequate to form a reasonable mistrust of it and to avoid using it for anything important to us. Reasons to keep this die rather than discard it might be to provide a source of mild entertainment or to use its bias for the purposes of cheating.

Some readers might be surprised to discover at this point that the results I presented from this apparently heavily-biased die are not only perfectly valid results obtained from a truly random unbiased die, they are to be fully expected. Even if the die had produced 100 sixes in that test, it would not confirm that the die is biased in any way whatsoever. Rolling a truly unbiased die once will produce one of six possible outcomes. Rolling the same die 100 times will produce one unique sequence out of the 6^100 (6.5 x 10^77) possible sequences: all of which are equally valid!

Gut feeling plus common sense rightfully informs us that the probability of a random die producing one hundred consecutive sixes is so incredibly remote that nobody will ever see it occur in reality. This conclusion is also mathematically sound: if there were 6.5 x 10^77 people on Earth, each performing the same test on truly random dice, there is no guarantee that anyone would observe a sequence of one hundred consecutive sixes.

When we observe a sequence such as 2 5 1 4 6 3 1 4 3 6 5 2… common sense informs us that the die is very likely random. If we calculate the arithmetic mean to be very close to 3.5 then common sense will lead us to conclude that the die is both random and unbiased enough to use it as a reliable source of random numbers.

Unfortunately, this is a perfect example of our gut feelings and common sense failing us abysmally. They totally failed to warn us that the 2 5 1 4 6 3 1 4 3 6 5 2… sequence we observed had exactly the same (im)probability of occurring as a sequence of one hundred 6s or any other sequence that one can think of that doesn’t look random to a human observer.

The 100-roll die test is nowhere near powerful enough to properly test a six-sided die, but this test is more than adequately powered to reveal some of our cognitive biases and some of the deficits in our personal mastery of science and critical thinking.

To properly test the die we need to provide solid evidence that it is both truly random and that its measured bias tends towards zero as the number of rolls tends towards infinity. We could use the services of one testing lab to conduct billions of test rolls, but this would not exclude errors caused by such things as miscalibrated equipment and experimenter bias. It is better to subdivide the testing across multiple labs then carefully analyse and appropriately aggregate the results: this dramatically reduces errors caused by equipment and humans.

In medicine, this testing process is performed via systematic reviews of multiple, independent, double-blind, placebo-controlled trials — every trial that is insufficiently powered to add meaningfully to the result is rightfully excluded from the aggregation.

Alt-med relies on a diametrically opposed testing process. It performs a plethora of only underpowered tests; presents those that just happen to show a positive result (just as a random die could’ve produced); and sweeps under the carpet the overwhelming number of tests that produced a negative result. It publishes only the ‘successes’, not its failures. By sweeping its failures under the carpet it feels justified in making the very bold claim: Our plethora of collected evidence shows clearly that it mostly ‘works’ and, when it doesn’t, it causes no harm.

One of the most acidic tests for a hypothesis and its supporting data (which is a mandatory test in a few branches of critical engineering) is to substitute the collected data for random data that has been carefully crafted to emulate the probability mass functions of the collected datasets. This test has to be run multiple times for reasons that I’ve attempted to explain in my random die example. If the proposer of the hypothesis is unable to explain the multiple failures resulting from this acid test then it is highly likely that the proposer either does not fully understand their hypothesis or that their hypothesis is indistinguishable from the null hypothesis.

Naturopathy can be defined as ‘an eclectic system of health care that uses elements of complementary and conventional medicine to support and enhance self-healing processes’. This basically means that naturopaths employ treatments based on those therapeutic options that are seen as natural, e. g. herbs, water, exercise, diet, fresh air, heat and cold – but occasionally also acupuncture, homeopathy and manual therapies. If you are tempted to see a naturopath, you might want to consider the following 7 points:

  1. In many countries, naturopathy is not a protected title; this means your naturopaths may have some training but this is not obligatory. Some medical doctors also practice naturopathy, and in some countries there are ‘doctors of naturopathy’ (these practitioners tend to see themselves as primary care physicians but they have not been to medical school).
  2. Naturopathy is steeped in the obsolete concept of vitalism which has been described as the belief that “living organisms are fundamentally different from non-living entities because they contain some non-physical element or are governed by different principles than are inanimate things.”
  3. While there is some evidence to suggest that some of the treatments used by naturopaths are effective for treating some conditions, this is by no means the case for all of the treatments in question.
  4. Naturopathy is implicitly based on the assumption that natural means safe. This notion is clearly wrong and misleading: not all the treatments used by naturopaths are strictly speaking natural, and very few are totally free of risks.
  5. Many naturopaths advise their patients against conventional treatments such as vaccines or antibiotics.
  6. Naturopaths tend to believe they can cure all or most diseases. Consequently many of the therapeutic claims for naturopathy found on the Internet and elsewhere are dangerously over-stated.
  7. The direct risks of naturopathy depend, of course, on the modality used; some of them can be considerable. The indirect risks of naturopathy can be even more serious and are mostly due to naturopathic treatments replacing more effective conventional therapies in cases of severe illness.

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