MD, PhD, FMedSci, FSB, FRCP, FRCPEd

alternative medicine

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The Royal Australian College of General  Practitioners (RACGP) just issued an important statement on homeopathy which, in several ways, goes beyond previous announcements on this subject. I take the liberty of reproducing it here in full:

The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making. In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions, the position of the RACGP is:

1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.

2. Pharmacists should not sell, recommend, or support the use of homeopathic products.

3. Homeopathic alternatives should not be used in place of conventional immunisation.

4. Private health insurers should not supply rebates for or otherwise support homeopathic services or products.

Background

The contention that homeopathy is an effective treatment is not supported by evidence from systematic literature reviews. The National Health and Medical Research Council (NHMRC) analysed the scientific evidence for the effectiveness of homeopathy in treating a range of clinical conditions and released a position statement [1] in March 2015. The NHMRC’s review concluded homeopathy does not produce health benefits over and above that of placebo, or equivalent to that of another treatment.[2] Crucially, the report states that there are “no health conditions for which there is reliable evidence that homeopathy is effective” as a treatment.

While not covered in the NHMRC’s review, it is also the case that homeopathic alternatives to conventional vaccination do not prevent communicable diseases or increase protective antibodies to disease. The National Centre for Immunisation Research and Surveillance has advised that there are no studies of sufficient quality to demonstrate the safety or effectiveness of ‘homeopathic vaccines’ for protection against disease.[3] Indeed, there is no plausible biological mechanism of action by which these products could prevent infection.[4]

Harms associated with homeopathy

Homeopathic products are sometimes considered harmless as they are generally administered at a high dilution. Some may not even contain a single molecule of the original source material. However, there are a number of risks associated with the use of homeopathy.

Delaying or avoiding conventional medical care

When the use of homeopathy causes a person to delay or avoid consultation with a registered medical practitioner or reject conventional medical approaches, serious and sometimes fatal consequences can occur. As evidenced by recent Australian court findings, spurious claims made by homeopathic practitioners[5] and retailers[6] can mislead individuals about the effectiveness of conventional medicine. When homeopathic vaccines are used as an alternative to conventional immunisation, both the individual and the community are left exposed to preventable diseases.

Problems associated with unregulated products

Although homeopathic products manufactured in Australia are regulated as medicines under the Therapeutic Goods Act 1989, products sold on international websites may not meet Australian quality and safety standards. These products may be of particular concern when materials from problematic sources are employed in the preparation (e.g., pathogenic organs or tissues; causative agents such as bacteria, fungi, parasites, ova, yeast, and virus particles; disease products; excretions or secretions; heavy metals and toxins such as aconitum, kerosene and thallium). Impurities of source material and contamination associated with poor manufacturing processes also present threats to the quality and safety of these products.[7]

Direct adverse effects

Various direct harms associated with the use of homeopathic products have been noted in the literature, including allergic reaction, drug interactions, and complications related to the ingestion of toxic substances.[8]

The importance of patient-centred practice

The RACGP supports the concept of patient-centred practice, in which the values, preferences, and personal healthcare philosophy of the patient are respected and individuals play an important role in their own healthcare. An estimated six per cent of Australians use homeopathy over the course of a year.[9] It is important that these patients feel comfortable in discussing their use of complementary and alternative medicines with all members of their treatment team.

It is good practice for medical practitioners to initiate conversations with patients about their use of or intention to use homeopathy, and assist patients to think critically about the efficacy and safety of homeopathy so that they may make informed healthcare decisions.

Private health insurance and homeopathy

Many private health insurers provide ancillary (extras) cover that subsidises homeopathic treatment, and the individual’s costs in taking out this cover are subsidised under the Australian Government’s private health insurance rebate. The RACGP is concerned that health insurance premiums continue to rise as funds disburse significant sums for the use of homeopathy and other natural therapies lacking rigorous evidentiary support. In the 2013–14 financial year, health insurers paid out $164 million in benefits for natural therapies, up by almost 60 per cent from 2010–11.[10]

The RACGP also notes that offering subsidies for the use of homeopathy sends a confusing message to consumers. Listing homeopathic treatments alongside evidence-based modalities in a list of member benefits lends legitimacy to a practice that is not supported by scientific data.

References

1. National Health and Medical Research Council. NHMRC Statement: Statement on Homeopathy. Canberra: NHMRC; 2015.

2. National Health and Medical Research Council. NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions. Canberra: NHMRC; 2015.

3. National Centre for Immunisation Research and Surveillance. Homeopathy and vaccination [fact sheet].2014 [cited 2015 April]. Available from http://www.ncirs.edu.au/immunisation/factsheets/homeopathyvaccination-
fact-sheet.pdf

4. Commonwealth Department of Health and Ageing. Myths and realities: Responding to arguments against vaccination. A guide for providers. Canberra: DoHA; 2013.

5. Coronial inquest into the death of Penelope Dingle. State Coroner of Western Australia, 2010.

6. Australian Competition and Consumer Commission v Homeopathy Plus! Pty Ltd. FCA, 2014.

7. World Health Organization. Safety issues in the preparation of homeopathic medicines. Geneva: WHO; 2009.

8. Posadzki P, Alotaibi A, Ernst E. Adverse effects of homeopathy: a systematic review of published case reports and case series. International Journal of Clinical Practice 2012 Dec;66(12): 1178–88.

9. Xue CCL, Zhang AL, Lin V, Da Costa C, Story DF. Complementary and alternative medicine use in Australia: a national population-based survey. Journal of Alternative and Complementary Medicine 2007; 13(16):643–50.

10. Private Health Insurance Administration Council. Operations of the Private Health Insurers Annual Report 2013–14. Canberra: PHIAC; 2014.

I think this is a very good statement:

  • it is based on the best evidence currently available,
  • it is concise and to the point,
  • it covers all the necessary ground,
  • it provides valuable and practical recommendations.

Perhaps I should mention that it came as a complete surprise to me, and I was not involved in any way.

Finally, I would like to express my hope that this statement will be adopted in Australia and send a powerful signal to organisations across the world to issue similar recommendations for the benefit of vulnerable patients who still fall victim to bogus claims by homeopaths every day.

On 26/5/2015, I received the email reproduced below. I thought it was interesting, looked up its author (“Shawn is a philosopher and writer educated at York University in Toronto, and the author of two books. He’s also worked with Aboriginal youth in the Northwest Territories of Canada”) and decided to respond by writing a blog-post rather than by answering Alli directly.

Hello Dr. Ernst, this is Shawn Alli from Canada, a blogger and philosopher. I recently finished a critical article on James Randi’s legacy. It gets into everything from ideological science, manipulation, ESP, faith healing, acupuncture and homeopathy.

Let me know what you think about it:

http://www.shawnalli.com/james-randi-disingenuous-legacy.html

It’s quite long so save it for a rainy day.

So far, the reply from skeptical organizations range from: “I couldn’t read further than the first few paragraphs because I disagree with the claims…” to one word replies: “Petty.”

It’s always nice to know how open-minded skeptical organizations are.

Hopefully you can add a bit more.

Sincerely,

Shawn

Yes, indeed, I can but try to add a bit more!

However, Alli’s actual article is far too long to analyse it here in full. I therefore selected just the bit that I feel most competent commenting on and which is closest to my heart. Below, I re-produce this section of Alli’s article in full. I add my comments at the end (in bold) by inserting numbered responses which refer to the numbers (in round brackets [the square ones refer to Alli’s references]) inserted throughout Alli’s text. Here we go:

Homeopathy & Acupuncture:

A significant part of Randi’s legacy is his war against homeopathy. This is where Randi shines even above mainstream scientists such as Dawkins or Tyson.

Most of his talks ridicule homeopathy as nonsense that doesn’t deserve the distinction of being called a treatment. This is due to the fact that the current scientific method is unable to account for the results of homeopathy (1). In reality, the current scientific method can’t account for the placebo effect as well (2).

But then again, that presents an internal problem as well. The homeopathic community is divided by those who believe it’s a placebo effect and those that believe it’s more than that, advocating the theory of water memory, which mainstream scientists ridicule and vilify (3).

I don’t know what camp is correct (4), but I do know that the homeopathic community shouldn’t follow the lead of mainstream scientists and downplay the placebo effect as, it’s just a placebo (5).

Remember, the placebo effect is downplayed because the current scientific method is unable to account for the phenomenon (3, 5). It’s a wondrous and real effect, regardless of the ridicule and vilification (6) that’s attached to it.

While homeopathy isn’t suitable as a treatment for severe or acute medical conditions, it’s an acceptable treatment for minor, moderate or chronic ones (7). Personally, I’ve never tried homeopathic treatments. But I would never tell individuals not to consider it. To each their own, as long as it’s within universal ethics (8).

A homeopathic community in Greece attempts to conduct an experiment demonstrating a biological effect using homeopathic medicine and win Randi’s million dollar challenge. George Vithoulkas and his team spend years creating the protocol of the study, only to be told by Randi to redo it from scratch. [29] (9) I recommend readers take a look at:

The facts about an ingenious homeopathic experiment that was not completed due to the “tricks” of Mr. James Randi.

Randi’s war against homeopathy is an ideological one (10). He’ll never change his mind despite positive results in and out of the lab (11). This is the epitome of dogmatic ideological thinking (12).

The same is true for acupuncture (13). In his NECSS 2012 talk Randi says:

Harvard Medical School is now offering an advanced course for physicians in acupuncture, which has been tested endlessly for centuries and it does not work in any way. And believe me, I know what I’m talking about. [30]

Acupuncture is somewhat of a grey area for mainstream scientists and the current scientific method. One ideological theory states that acupuncture operates on principles of non-physical energy in the human body and relieving pressure on specific meridians. The current scientific method is unable to account for non-physical human energy and meridians.

A mainstream scientific theory of acupuncture is one of neurophysiology, whereby acupuncture works by affecting the release of neurotransmitters. I don’t know which theory is correct; but I do know that those who do try acupuncture usually feel better (14).

In regards to the peer-reviewed literature, I believe (15) that there’s a publication bias against acupuncture being seen as a viable treatment for minor, moderate or chronic conditions. A few peer-reviewed articles support the use of acupuncture for various conditions:

Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia. [31]

It is concluded that this study showed highly positive effects on pain and function through the collaborative treatment of acupuncture and motion style in aLBP [acute lower back pain] patients. [32]

Given the limited efficacy of antidepressant treatment…the present study provides evidence in supporting the viewpoint that acupuncture is an effective and safe alternative treatment for depressive disorders, and could be considered an alternative option especially for patients with MDD [major depressive disorder] and PSD [post-stroke depression], although evidence for its effects in augmenting antidepressant agents remains controversial. [33]

In conclusion: We find that acupuncture significantly relieves hot flashes and sleep disturbances in women treated for breast cancer. The effect was seen in the therapy period and at least 12 weeks after acupuncture treatment ceased. The effect was not correlated with increased levels of plasma estradiol. The current study showed no side effects of acupuncture. These results indicate that acupuncture can be used as an effective treatment of menopausal discomfort. [34]

In conclusion, the present study demonstrates, in rats, that EA [electroacupuncture] significantly attenuates bone cancer induced hyperalgesia, which, at least in part, is mediated by EA suppression of IL-1…expression. [35]

In animal model of focal cerebral ischemia, BBA [Baihui (GV20)-based Scalp acupuncture] could improve IV [infarct volume] and NFS [neurological function score]. Although some factors such as study quality and possible publication bias may undermine the validity of positive findings, BBA may have potential neuroprotective role in experimental stroke. [36]

In conclusion, this randomized sham-controlled study suggests that electroacupuncture at acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou is more effective than no acupuncture and sham acupuncture in stimulating early return of bowel function and reducing postoperative analgesic requirements after laparoscopic colorectal surgery. Electroacupuncture is also more effective than no acupuncture in reducing the duration of hospital stay. [37]

In conclusion, we found acupuncture to be superior to both no acupuncture control and sham acupuncture for the treatment of chronic pain…Our results from individual patient data meta-analyses of nearly 18000 randomized patients in high-quality RCTs [randomized controlled trials] provide the most robust evidence to date that acupuncture is a reasonable referral option for patients with chronic pain. [38]

While Randi and many other mainstream scientists will argue (16) that the above claims are the result of ideological science and cherry picking, in reality, they’re the result of good science going up against dogmatic (17) and profit-driven (17) ideological (17) science.

Yes, the alternative medicine industry is now a billion dollar industry. But the global pharmaceutical medical industry is worth hundreds of trillions of dollars. And without its patients (who need to be in a constant state of ill health), it can’t survive (18).

Individuals who have minor, moderate, or chronic medical conditions don’t want to be part of the hostile debate between alternative medicine vs. pharmaceutical medical science (19). They just want to get better and move on with their life. The constant war that mainstream scientists wage against alternative medicine is only hurting the people they’re supposed to be helping (20).

Yes, the ideologies (21) are incompatible. Yes, there are no accepted scientific theories for such treatments. Yes, it defies what mainstream scientists currently “know” about the human body (22).

It would be impressive if a peace treaty can exist between both sides, where both don’t agree, but respect each other enough to put aside their pride and help patients to regain their health (23).

END OF ALLI’S TEXT

And here are my numbered comments:

(1) This is not how I understand Randi’s position. Randi makes a powerful point about the fact that the assumptions of homeopathy are not plausible, which is entirely correct – so much so that even some leading homeopaths admit that this is true.

(2) This is definitely not correct; the placebo effect has been studied in much detail, and we can certainly ‘account’ for it.

(3) In my 40 years of researching homeopathy and talking to homeopaths, I have not met any homeopaths who “believe it’s a placebo effect”.

(4) There is no ‘placebo camp’ amongst homeopaths; so this is not a basis for an argument; it’s a fallacy.

(5) They very definitely are mainstream scientists, like F Benedetti, who research the placebo effect and they certainly do not ‘downplay’ it. (What many people fail to understand is that, in placebo-controlled trials, one aims at controlling the placebo effect; to a research-naïve person, this may indeed LOOK LIKE downplaying it. But this impression is wrong and reflects merely a lack of understanding.)

(6) No serious scientist attaches ‘ridicule and vilification’ to it.

(7) Who says so? I know only homeopaths who hold this opinion; and it is not evidence-based.

(8) Ethics proscribe that patients require the best available treatment; homeopathy does not fall into this category.

(9) At one stage (more than 10 years ago), I was involved in the design of this test. My recollection of it is not in line with the report that is linked here.

(10) So far, we have seen no evidence for this statement.

(11) Which ones? No examples are provided.

(12) Yet another statement without evidence – potentially libellous.

(13) Conclusion before any evidence; sign for a closed mind?

(14) This outcome could be entirely unrelated to acupuncture, as anyone who has a minimum of health care knowledge should know.

(15) We are not concerned with beliefs, we concerned with facts here, aren’t we ?

(16) But did they argue this? Where is the evidence to support this statement?

(17) Non-evidence-based accusations.

(18) Classic fallacy.

(19) The debate is not between alt med and ‘pharmaceutical science’, it is between those who insist on treatments which demonstrably generate more good than harm, and those who want alt med regardless of any such considerations.

(20) Warning consumers of treatments which fail to fulfil the above criterion is, in my view, an ethical duty which can save much money and many lives.

(21) Yes, alt med is clearly ideology-driven; by contrast conventional medicine is not (if it were, Alli would have explained what ideology it is precisely). Conventional medicine changes all the time, sometimes even faster than we can cope with, and is mainly orientated on evidence which is not an ideology. Alt med hardly changes or progresses at all; for the most part, its ideology is that of a cult celebrating anti-science and obsolete traditions.

(22) Overt contradiction to what Alli just stated about acupuncture.

(23) To me, this seems rather nonsensical and a hindrance to progress.

In summary, I feel that Alli argues his corner very poorly. He makes statements without supporting evidence, issues lots of opinion without providing the facts (occasionally even hiding them), falls victim of logical fallacies, and demonstrates an embarrassing lack of knowledge and common sense. Most crucially, the text seems bar of any critical analysis; to me, it seems like a bonanza of unreason.

To save Alli the embarrassment of arguing that I am biased or don’t know what I am talking about, I’d like to declare the following: I am not paid by ‘Big Pharma’ or anyone else, I am not aware of having any other conflicts of interest, I have probably published more research on alt med (some of it with positive conclusions !!!) than anyone else on the planet, my research was funded mostly by organisations/donors who were in favour of alt med, and I have no reason whatsoever to defend Randi (I only met him personally once). My main motivation for responding to Alli’s invitation to comment on his bizarre article is that I have fun exposing ‘alt med nonsense’ and believe it is a task worth doing.

Time for some fun!

In alternative medicine, there often seems to be an uneasy uncertainty about research methodology. This is, of course, regrettable, as it can (and often does) lead to misunderstandings. I feel that I have some responsibility to educate research-naïve practitioners. I hope this little dictionary of research terminology turns out to be a valuable contribution in this respect.

Abstract: a concise summary of what you wanted to do skilfully hiding what you managed to do.

Acute: an exceptionally good-looking nurse.

Adverse reaction: a side effect of a therapy that I do not practise.

Anecdotal evidence: the type of evidence that charlatans prefer.

Audit: misspelled name of German car manufacturer.

Avogadro’s number: telephone number of an Italian friend.

Basic research: investigations which are too simplistic to bother with.

Best evidence synthesis: a review of those cases where my therapy worked extraordinarily well.

Bias: prejudice against my therapy held by opponents.

Bioavailability: number of health food shops in the region.

Bogus: a term Simon Singh tried to highjack, but chiropractors sued and thus got the right use it for characterising their trade.

Chiropractic manipulation: a method of discretely adjusting data so that they yield positive results.

Confidence interval: the time between reading a paper and realising that it is rubbish.

Confounder: founder of a firm selling bogus treatments.

Conflict of interest: bribery by ‘Big Pharma’.

Data manipulation: main aim of chiropractic.

Declaration of Helsinki: a statement by the Finnish Society for Homeopathy in favour of treating Ebola with homeopathy.

Dose response: weird concept of pharmacologists which has been disproven by homeopathy.

Controlled clinical trial: a study where I am in control of the data and can prettify them, if necessary.

Critical appraisal: an assessment of my work by people fellow charlatans.

Doctor: title mostly used by chiropractors and naturopaths.

EBM: eminence-based medicine.

Error: a thing done by my opponents.

Ethics: misspelled name of an English county North of London.

Evidence: the stuff one can select from Medline when one needs a positive result in a hurry.

Evidence-based medicine: the health care based on the above.

Exclusion criteria: term used to characterise material that is not to my liking and must therefore be omitted.

Exploratory analysis: valuable approach of re-analysing negative results until a positive finding pops up.

Focus group: useful method for obtaining any desired outcome.

Forest plot: a piece of land with lots of trees.

Funnel plot: an intrigue initiated by Prof Funnel to discredit homeopathy.

Good clinical practice: the stuff I do in my clinical routine.

Grey literature: print-outs of articles from a faulty printer.

Hawthorne effect: the effects of Crataegus on cardiovascular function.

Hierarchy of evidence: a pyramid with my opinion on top.

Homeopathic delusion: method of manufacturing a homeopathic remedy.

Informed consent: agreement of patients to pay my fee.

Intention to treat analysis: a method of calculating data in such a way that they demonstrate what I intended to show.

Logic: my way of thinking.

Mean: attitude of chiropractors to anyone suggesting their manipulations are not a panacea.

Metastasis: lack of progress with a meta-analysis.

Numbers needed to treat: amount of patients I require to make a good living.

Odds ratio: number of lunatics in my professional organisation divided by the number of people who seem normal.

Observational study: results from a few patients who did exceptionally well on my therapy.

Pathogenesis: a rock group who have fallen ill.

Peer review: assessment of my work by several very close friends of mine.

Pharmacodynamics: the way ‘Big Pharma’ is trying to supress my findings.

Pilot study: a trial that went so terribly wrong that it became unpublishable – but, in the end, we still got it in an alt med journal.

Placebo-effect: a most useful phenomenon that makes patients who receive my therapy feel better.

Pragmatic trial: a study that is designed to generate the result I want

Silicon Valley: region in US where most stupid fraudsters are said to come from.

Standard deviation: a term describing the fact that deviation from the study protocol is normal.

Statistics: a range of methods which are applied to the data until they eventually yield a significant finding.

Survey: popular method of interviewing a few happy customers in order to promote my practice.

Systematic review: a review of all the positive results I could find.

 

 

Like it? If so, why don’t you suggest a few more entries into my dictionary via the comment section below?

I have repeatedly stressed that herbal remedies can cause harm in a range of ways. Indian rheumatologists recently enforced this point by publishing a case-report of adrenal suppression caused by herbal remedies.

A 49-year-old male presented with polyarthritis from which he had suffered for more than 10 years. His serum cortisol levels were extremely low, he had vitamin D deficiency, and his rheumatoid factor was negative. He revealed symptoms of adrenal suppression, mainly muscle weakness and suicidal tendency, and few other psychiatric disturbances.

The patient eventually discontinued his herbal medicine. Then, he was put on deflazacort for 12 weeks at 12 mg twice daily and later the dose was tapered to 6 mg/day. Deflazocort, an intermediate-acting corticosteroid, was prescribed to minimize the probable withdrawal symptoms due to the probable presence of dexamethasone or betamethasone (long-acting steroids) presumably from the herbal medication.

The herbal samples of used by the patient was analysed by mass spectrometry. It showed the presence of steroidal compounds by the mass 393.81, which may be dexamethasone or betamethasone.

The authors of this paper believe that the symptoms of adrenal suppression could have precipitated or exacerbated the neuropsychiatric disturbances due to Hypothalamus-Pituitary-Adrenal (HPA) suppression. In their view, adrenal suppression following ingestion of herbal remedies is of major concern. Abrupt withdrawal of such products could precipitate adrenal failure which can be fatal.

It should be added, I think, that such illegal adulterations of herbal remedies have been reported with some regularity, particularly in Indian (and Chinese) preparations. Our systematic review showed that this problem has caused serious harm. The most severe documented adverse effects include agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral edema, coma, intracerebral haemorrhage, and death.

As under-reporting can be suspected to be huge, we do currently not know how frequent these events are.

This is a question which I have asked myself more often than I care to remember. The reason is probably that, in alternative medicine, I feel surrounded by so much dodgy research that I simply cannot avoid asking it.

In particular, the co-called ‘pragmatic’ trials which are so much ‘en vogue’ at present are, in my view, a reason for concern. Take a study of cancer patients, for instance, where one group is randomized to get the usual treatments and care, while the experimental group receives the same and several alternative treatments in addition. These treatments are carefully selected to be agreeable and pleasant; each patient can choose the ones he/she likes best, always had wanted to try, or has heard many good things about. The outcome measure of our fictitious study would, of course, be some subjective parameter such as quality of life.

In this set-up, the patients in our experimental group thus have high expectations, are delighted to get something extra, even more happy to get it for free, receive plenty of attention and lots of empathy, care, time, attention etc. By contrast, our poor patients in the control group would be a bit miffed to have drawn the ‘short straw’ and receive none of this.

What result do we expect?

Will the quality of life after all this be equal in both groups?

Will it be better in the miffed controls?

Or will it be higher in those lucky ones who got all this extra pampering?

I don’t think I need to answer these questions; the answers are too obvious and too trivial.

But the real and relevant question is the following, I think: IS SUCH A TRIAL JUST SILLY AND MEANINGLESS OR IS IT UNETHICAL?

I would argue the latter!

Why?

Because the results of the study are clearly known before the first patient had even been recruited. This means that the trial was not necessary; the money, time and effort has been wasted. Crucially, patients have been misled into thinking that they give their time, co-operation, patience etc. because there is a question of sufficient importance to be answered.

But, in truth, there is no question at all!

Perhaps you believe that nobody in their right mind would design, fund and conduct such a daft trial. If so, you assumed wrongly. Such studies are currently being published by the dozen. Here is the abstract of the most recent one I could find:

The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients. 

The key sentence in this abstract is, of course: complementary medicine intervention improved quality of life of breast cancer patients… It provides the explanation as to why these trials are so popular with alternative medicine researchers: they are not real research but they are quite simply promotion! The next step would be to put a few of those pseudo-scientific trials together and claim that there is solid proof that integrating alternative treatments into conventional health care produces better results. At that stage, few people will bother asking whether this is really due to the treatments in questioning or to the additional attention, pampering etc.

My question is ARE SUCH TRIALS ETHICAL?

I would very much appreciate your opinion.

Many people suffering from depression or anxiety are tempted to try alternative therapies. One of those is Reiki, a 2500 year old treatment described as a vibrational or subtle energy therapy, and is most commonly facilitated by light touch on or above the body. On this blog, we have repeatedly discussed Reiki and the fact that there is no good evidence for this utterly implausible approach (e.g. here, here and here). Yet, there have been reports of Reiki alleviating anxiety and depression – but what does the totality of the available evidence show when it is submitted to an impartial assessment?

This Cochrane review was aimed at evaluating the effectiveness of Reiki for treating anxiety and depression in people aged 16 and over.

Literature searches were conducted in the Cochrane Register of Controlled Trials (CENTRAL – all years), the Cochrane Depression, Anxiety and Neurosis Review Group’s Specialised Register (CCDANCTR – all years), EMBASE, (1974 to November 2014), MEDLINE (1950 to November 2014), PsycINFO (1967 to November 2014) and AMED (1985 to November 2014). Additional searches were carried out on the World Health Organization Trials Portal (ICTRP) together with ClinicalTrials.gov to identify any ongoing or unpublished studies. All searches were up to date as of 4 November 2014.

Randomised trials were considered in adults with anxiety or depression or both, with at least one arm treated with Reiki delivered by a trained Reiki practitioner. The two authors independently decided on inclusion/exclusion of studies and extracted data. A prior analysis plan had been specified.

The researchers found three studies for inclusion in the review. One recruited males with a biopsy-proven diagnosis of non-metastatic prostate cancer who were not receiving chemotherapy and had elected to receive external-beam radiation therapy; the second study recruited community-living participants who were aged 55 years and older; the third study recruited university students.These studies included subgroups with anxiety and depression as defined by symptom scores and provided data separately for those subgroups. As this included only 25 people with anxiety and 17 with depression and 20 more with either anxiety or depression, but which was not specified, the results could only be reported narratively.

The findings did not show any evidence that Reiki is either beneficial or harmful in this population. The risk of bias for the included studies was generally rated as unclear or high for most domains, which reduced the certainty of the evidence.

The authors of this Cochrane review concluded that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.

This is a very diplomatic way of expressing the truth, I think. A more forceful conclusion might have been that THERE IS NO GOOD EVIDENCE THAT REIKI IS EFFECTIVE. GIVEN THE TOTAL LACK OF BIOLOGICAL PLAUSIBILITY, THIS FINDING IS NOT SURPRISING. FUTURE RESEARCH INTO THIS AREA DOES NOT SEEM WARRANTED.

There are things that cannot be said too often. In medicine, these are often related to issues that can save lives. In alternative medicine, it is worth remembering that there is nothing that can save more lives than the following rule: EVEN AN APPARENTLY HARMLESS REMEDY WILL BECOME LIFE-THREATENING, IF IT IS USED AS AN ALTERNATIVE TO AN EFFECTIVE THERAPY FOR A SERIOUS CONDITION.

Here is a publication that serves as a very sad reminder of this important axiom.

Japanese physicians recently published a case-report of 2-year-old girl who died of precursor B-cell acute lymphoblastic leukaemia (ALL), the most common cancer in children. She had no remarkable medical history. She was transferred to a hospital because of respiratory distress and died 4 hours after arrival.

Two weeks before her death, she had developed a fever of 39°C, which subsided after the administration of a naturopathic herbal remedy. Subsequently, she developed jaundice one week before death, and her condition worsened on the day of death.

Laboratory test results on admission showed a markedly elevated white blood cell count. Accordingly, the cause of death was suspected to be acute leukaemia. Forensic autopsy revealed the cause of death to be precursor B-cell ALL.

With advancements in medical technology, the 5-year survival rate of children with ALL is nearly 90%. However, in this case, the deceased’s parents preferred alternative medicine to evidence-based medicine and had not taken her to a hospital for a medical check-up or immunisation since she was an infant. The authors state that, if she had received routine medical care, she would have a more than 60% chance of being alive 5 years after diagnosis. Therefore, we conclude that the parents should be accused of medical neglect regardless of their motives.

Alternative practitioners who treat their patients in this way, are in my experience often full of good intentions. They remind me of something Bert Brecht one wrote: THE OPPOSITE OF GOOD IS NOT EVIL, IT IS GOOD INTENTIONS.

A new study of homeopathic arnica suggests efficacy. How come?

Subjects scheduled for rhinoplasty surgery with nasal bone osteotomies by a single surgeon were prospectively randomized to receive either oral perioperative arnica or placebo in a double-blinded fashion. A commercially available preparation was used which contained 12 capsules: one 500 mg capsule with arnica 1M is given preoperatively on the morning of surgery and two more later that day after surgery. Thereafter, arnica was administered in the 12C potency three times daily for the next 3 days (“C” indicates a 100-fold serial dilution; and M, a 1000-fold dilution)

Ecchymosis was measured in digital “three-quarter”-view photographs at three postoperative time points. Each bruise was outlined with Adobe Photoshop and the extent was scaled to a standardized reference card. Cyan, magenta, yellow, black, and luminosity were analyzed in the bruised and control areas to calculate change in intensity.

Compared with 13 subjects receiving placebo, 9 taking arnica had 16.2%, 32.9%, and 20.4% less extent on postoperative days 2/3, 7, and 9/10, a statistically significant difference on day 7. Color change initially showed 13.1% increase in intensity with arnica, but 10.9% and 36.3% decreases on days 7 and 9/10, a statistically significant difference on day 9/10. One subject experienced mild itching and rash with the study drug that resolved during the study period.

The authors concluded that Arnica montana seems to accelerate postoperative healing, with quicker resolution of the extent and the intensity of ecchymosis after osteotomies in rhinoplasty surgery, which may dramatically affect patient satisfaction.

Why are the results positive? Pervious systematic reviews confirm that homeopathic arnica is a pure placebo. First, I thought the answer lies in the 1M potency. It could well still contain active molecules. But then I realised that the answer is much more simple: if we apply the conventional level of statistical significance, there are no statistically significant differences to placebo at all! I had not noticed the little sentence by the authors: a P value of 0.1 was set as a meaningful difference with statistical significance. In fact, none of the effects called significant by the authors pass the conventionally used probability level of 5%.

So, what so the results of this new study truly mean? In my view, they show what was known all along: HOMEOPATHIC REMEDIES ARE PLACEBOS.

I thought I had a fairly good understanding of homeopathy; well I seem to have been wrong. A German child/adolescent psychiatrist and homeopathic physician has recently published a paper which I find most impressive. Not that it conveys new data or facts, quite the opposite. I find it impressive, because I do not understand a word of it. Here is the summary and the conclusion; if you want to read the full article, this link will take you to it.

Efforts have been made to integrate homeopathy into the system of natural sciences. In this article an alternative approach is offered. The very base of physics and mathematics, on which natural sciences are grounded are time, space and number. Since Immanuel Kant they are believed to be a priori given. Alternatively they can be explained as a consequence of life, such that the outside world in the form, as we perceive it, should no longer be considered independent from us as living beings. Having understood the base of physics, homeopathy does not have to be integrated into an existing system of natural sciences, but can be allowed to be more closely connected to the proper origin of physics, which is life itself.

We come to the conclusion that mathematics and physics are a sequel of life. What we perceive in an outside world is a projection not only of our mind, but also of life itself. It is not an individual projection, but a projection that we share with other living beings. We share some of the aspects of reality with only a few other humans, like the understanding of art, with most humans and some species we share the ability to perceive music or colours. Still broader aspects of what we perceive as reality are common to us and other animal species: firmness, light and sound. With all species we share the aspects of time, space and separateness, oneness. Thus reality is a collective subjective autosuggestion across species. Its outside reality functions on mathematical rules, because mathematics and physics share the common ground, which is time, space and number as a continuation of oneness in time, all sequels of life.

Homeopathy however does not. It does not, because it has a direct connection to life without the detour across outside physics.

If there is someone out there who understands what all this is about, please do enlighten us.

A few years ago, I fell ill with shingles. When patients had consulted me for this condition, during the times when I still was a clinician, I always had to stop myself smiling; they complained bitterly but, really, this was far from serious. Now, affected myself, I did not smile a bit: this was incredibly painful!

I promptly saw my GP in Exeter who, to my utter amazement, prescribed paracetamol. She too seemed to think that this was really nothing to bother her with. As I had feared, the paracetamol did absolutely nothing to my pain. After a few sleepless nights, I went back and asked for something a little more effective. She refused, and I decided to change GP.

Meanwhile, we went on a scheduled holiday to France. I had hoped my shingles would come to a natural end, but my pain continued unabated. People could see it on my face; so our kind neighbour asked whether she could help. I explained the situation, and she instantly claimed to have just the right treatment for me: she knew a healer who lived just round the corner and had helped many of her friends when they had suffered from pain.

“A healer?” I asked, “you cannot be serious.” I explained that I had conducted studies and done other research into this particular subject. Without exception, the results had shown that healing is a pure placebo. “I prefer to carry on taking even something as useless as paracetamol!” I insisted.

But she would have none of it. The next time I saw her, she declared triumphantly that she had made an appointment for me, and there was no question: I had to go.

As it happened, the day before she announced this, I had met up with a doctor friend of mine who, seeing I was in agony, gave me a prescription for gabapentin. In fact, I was just on the way to the pharmacist to pick it up. Thus I was in hopeful that my ordeal was coming to an end. In this optimistic mood I thanked my neighbour for her effort and concern and said something non-committal like “we shall see”.

A few days later, we met again. By this time, the gabapentin had done it’s trick: a was more or less pain-free, albeit a little dazed from the powerful medication. When my neighbour saw me, she exclaimed: “I see that that you are much improved. Wonderful! Yesterday’s healing session has worked!!!”

In my daze, I had forgotten all about the healing, and I had, of course, not been to see the healer. She was so delighted with her coup, that I did not have the heart to tell her the truth. I only said “yes much better, merci”

These events happened a few years ago, but even today, my kind and slightly alternative neighbour believes that, despite having been highly sceptical, healing has cured me of my shingles. To my embarrassment, she occasionally mentions my ‘miraculous cure’.

One day, I must tell her the truth… on second thoughts, perhaps not, she might claim it was distant healing!

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