Updated Edition!
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.
In the world of homeopathy, the truth is often much weirder than fiction. Take this recent article, for instance; it was published by the famous lay homeopath Alan Schmukler in the current issue of ‘HOMEOPATHY 4 EVERYONE’.
Before you read the text in question, it might be relevant to explain who Schmukler is: he attended Temple University, where he added humanistic psychology to his passions. After graduating Summa Cum Laude, Phi Beta Kappa and President’s Scholar, he spent several years doing workshops in human relations. Alan also studied respiratory therapy and worked for three years at Einstein Hospital in Philadelphia. Those thousands of hours in the intensive care and emergency rooms taught him both the strengths and limitations of conventional medicine. Schmukler learned about homeopathy in 1991 when he felt he had been cured of an infection with Hepar sulph. He later founded the Homeopathic Study Group of Metropolitan Philadelphia, giving free lectures and hosting the areas best homeopaths to teach. He also helped found and edit Homeopathy News and Views, a popular culture newsletter on homeopathy. He taught homeopathy for Temple University’s Adult Programs, and has been either studying, writing, lecturing or consulting on homeopathy since 1991. He wrote Homeopathy An A to Z home Handbook, which is now available in five languages. Alan Schmukler has been practicing homeopathy for more than two decades and is Chief Editor of Hpathy.com and of Homeopathy4Everyone. He says that his work as Editor is one of his most rewarding experiences.
Now, brace yourself, here is the promised text/satire (in bold); I promise, I did not change a single word:
EIGHT REASONS TO VACCINATE YOUR CHILD
- Your child is deficient in Mercury, Aluminum, Formaldehyde, viruses, foreign DNA or other ingredients proven to cause neurological damage.
- Your child has an excess of healthy, functioning brain cells.
- You need more cash. The National Vaccine Injury Compensation program has paid out 2.8 billion dollars to parents of children injured or killed by vaccines.
- You and your husband are feeling alienated and you need a crisis to bring you together.
- You believe that pharmaceutical conglomerates which earn billions from vaccines are more credible than consumer groups.
- You think thousands of parents who report that their children became autistic two weeks after vaccination are lying.
- You don’t see a problem in logic when the government tells you that vaccines work, but that vaccinated children can catch diseases from unvaccinated children.
- You think the government should dictate which healing methods you and your children are allowed to use.
Funny? No!
Bad taste? Very much so!
Barmy? I think so!
Dangerous? Yes!
Irresponsible? Most certainly!
Unethical? Yes!
Characteristic for lay homeopathy? Possibly!
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!
In my last post, I made a fairly bold statement without any evidence to support it: “[this] demonstrates once again that, in the realm of alternative medicine, organisations and individuals make statements that sound fine and are politically correct, while at the same time disregarding these pompous aims/visions/objectives by promoting outright quackery. This sort of thing is so wide-spread that most of us just take it for granted and very few have the nerve to object. The result of this collective behaviour is obvious: on the one hand, charlatans can claim to be entirely in line with public health, EBM etc.; on the other hand, they are free to exploit the public with their bogus treatments.”
I felt that my statement was supported by so many websites that it was almost self-evident. But, as it happens, I was alerted today to another website that provides impressive first had evidence of what I meant:
“The purpose of this site is to provide the public with information about Craniosacral Therapy
Craniosacral therapists recognise health as an active principle. This health is the expression of life – an inherent ordering force, a natural internal intelligence. Craniosacral Therapy is a subtle and profound healing form which assists this natural bodily intelligence.
It is clear that a living human organism is immensely complex and requires an enormous amount of internal organisation. Craniosacral Therapy helps nurture these internal ordering principles. It helps increase physical vitality and well-being, not only effecting structural change, but also having much wider implications e.g. improving interpersonal relationships, managing life more appropriately etc…
The work can address issues in whatever way the client wishes; physical aches and pains, acute and chronic disease, emotional or psychological disturbances, or simply developing well-being, health and vitality.
Craniosacral Therapy is so gentle that it is suitable for babies, children, and the elderly, as well as adults; and also in fragile or acutely painful conditions. As a whole-body therapy, treatment may aid almost every condition, raising the vitality and enabling the body’s own self-healing process to be utilised.”
I find this text rather typical and very revealing: the authors first make several bland statements which are little more that politically correct platitudes. Eventually, they try to tell us what their therapy is good for: it is suitable for babies adults and the elderly. In other words, it is for everyone!
And what is so truly brilliant, it can be used to treat acute and chronic conditions. In other words, it is effective for every disease afflicting mankind!
Once you have realised it, the strategy of such ‘position statements’ (or whatever they might call it) is all too obvious: behind a smokescreen of empty platitudes, quackery is being promoted for profit. The phraseology used is such that there can be little concrete objections in legal or regulatory terms. All the therapeutic claims are general, cleverly hidden and operate merely by implication.
Quackery? Yes, absolutely!
Craniosacral therapy has not been proven to be effective for anything and, as a therapy, it is therefore not ‘suitable’ for anyone. To me, this is almost the definition of quackery.
