Highly diluted homeopathic remedies are pure placebos! This is what the best evidence clearly shows. Ergo they cannot be shown in a rigorous study to have effects that differ from placebo. But now there is a study that seems to contradict this widely accepted conclusion.
Can someone please help me to understand what is going on?
In this double-blind, placebo-controlled RCT, 60 patients suffering from insomnia were treated either individualised homeopathy (IH) or placebo for 3 months. Patient-administered sleep diary and Insomnia Severity Index (ISI) were used the primary and secondary outcomes respectively, measured at baseline, and after 3 months.
Five patients dropped out (verum:2,control:3).Intention to treat sample (n=60) was analysed. Trial arms were comparable at baseline. In the verum group, except sleep diary item 3 (P= 0.371), rest of the outcomes improved significantly (all P < 0.01). In the control group, there were significant improvements in diary item 6 and ISI score (P < 0.01) and just significant improvement in item 5 (P= 0.018). Group differences were significant for items 4, 5 and 6(P < 0.01) and just significant (P= 0.014) for ISI score with moderate to large effect sizes; but non-significant (P > 0.01) for rest of the outcomes.
The authors concluded that in this double-blind, randomized, prospective, placebo-controlled, two parallel arms clinical trial conducted on 60 patients suffering from insomnia, there was statistically significant difference measured in sleep efficiency, total sleep time, time in bed, and ISI score in favour of homeopathy over placebo with moderate to large effect sizes. Group differences were non-significant for rest of the outcomes(i.e. latency to fall asleep, minutes awake in middle of night and minutes awake too early). Individualized homeopathy seemed to produce significantly better effect than placebo. Independent replications and adequately powered trials with enhanced methodological rigor are warranted.
I have studied this article in some detail; its methodology is nicely and fully described in the original paper. To my amazement, I cannot find a flaw that is worth mentioning. Sure, the sample was small, the treatment time short, the outcome measure subjective, the paper comes from a dubious journal, the authors have a clear conflict of interest, even though they deny it – but none of these limitations has the potential to conclusively explain the positive result.
In view of what I stated above and considering what the clinical evidence so far tells us, this is most puzzling.
A 2010 systematic review authored by proponents of homeopathy included 4 RCTs comparing homeopathic medicines to placebo. All involved small patient numbers and were of low methodological quality. None demonstrated a statistically significant difference in outcomes between groups.
My own 2011 not Medline-listed review (Focus on Alternative and Complementary Therapies Volume 16(3) September 2011 195–199) included several additional studies. Here is its abstract:
The aim of this review was the critical evaluation of evidence for the effectiveness of homeopathy for insomnia and sleep-related disorders. A search of MEDLINE, AMED, CINAHL, EMBASE and Cochrane Central Register was conducted to find RCTs using any form of homeopathy for the treatment of insomnia or sleep-related disorders. Data were extracted according to pre-defined criteria; risk of bias was assessed using Cochrane criteria. Six randomised, placebo-controlled trials met the inclusion criteria. Two studies used individualised homeopathy, and four used standardised homeopathic treatment. All studies had significant flaws; small sample size was the most prevalent limitation. The results of one study suggested that homeopathic remedies were superior to placebo; however, five trials found no significant differences between homeopathy and placebo for any of the main outcomes. Evidence from RCTs does not show homeopathy to be an effective treatment for insomnia and sleep-related disorders.
It follows that the new trial contradicts previously published evidence. In addition, it clearly lacks plausibility, as the remedies used were highly diluted and therefore should be pure placebos. So, what could be the explanation of the new, positive result?
As far as I can see, there are the following possibilities:
- some undetected/undisclosed bias,
- homeopathy works after all.
I would be most grateful, if someone could help solving this puzzle for me (if needed, I can send you the full text of the new article for assessment).
Oscillococcinum is by now well-known to readers of this blog, I am sure (see for instance here, here and here). It seems an important topic, not least because the infamous duck-placebo is the world’s best-selling homeopathic remedy. Just how popular it is was recently shown in a survey by the formidable ‘Office for Science and Society’ of the McGill University in Canada.
The researchers surveyed the five biggest pharmacy chains in Quebec: Jean-Coutu, Familiprix, Uniprix, Proxim, and Pharmaprix. For each chain, a sample of 30 pharmacies was chosen by a random number generator.
The calls started with the following script: “I would like to know if you carry a certain homeopathic remedy. It’s called Oscillococcinum, it’s a homeopathic remedy against the flu made by Boiron.” If they did not have it, the investigator asked if this was something they normally carried. He spoke to either a floor clerk or a member of the pharmacy staff behind the counter, depending on who knew the answer.
Out of the 150 pharmacies on the island of Montreal that were called for this investigation, 66% of them reported carrying Oscillococcinum (30% did not, while 4% could not be reached, often because the listed pharmacy had closed). Some chains were more likely to sell the product, with Jean-Coutu and Pharmaprix being the most likely (80% of their stores had it) and Proxim being the least likely (50% of their stores carried it).
The McGill researcher stated that the fact that two-thirds of Montreal-based pharmacies will sell us a pseudo-treatment for the flu that targets adults, children and infants alike is hard to square with the Quebec Order of Pharmacists’ mission statement. They describe said mission as “ensuring the protection of the public”, but how is the public protected when pharmacies are selling them placebo pills? The harm is partly financial: 30 doses of these worthless globules retail for CAD 36. It is also in the false sense of security parents will gain and the delay in proper treatment if needed. And, ultimately, it is in the legitimization of a pseudoscience the founding principle of which is that the more you add water to something (like alcohol), the more powerful it becomes.
I can only full-heartedly agree. One might even add a few more things, for instance that there are other dangers as well:
- If pharmacists put commercial gain before medical ethics, we might find it hard to trust this profession.
- If people take Oscillococcinum and their condition subsequently disappears (because of the self-limiting nature of the disease), they might believe that homeopathy is effective and consequently use it for much more serious conditions – with grave consequences, I hasten to add.
- If consumers thus start trusting homeopaths, they might also fall for some of their abominable health advice, e. g. that about not vaccinating their children.
- If a sufficiently large percentage of people believe in the magic of shaken water, our rationality will be undermined and we will encounter phenomena like Brexit or fascists as presidents (sorry, I has to get that off my chest).
The claim that homeopathy can cure cancer is so absurd that many people seem to think no homeopaths in their right mind would make it. Sadly, this turns out to be not true. A rather dramatic example is this extraordinary book. Here is what the advertisement says:
The global medical fraternity has been exploring various alternative approaches to cancer treatment. However, this exceptional book, “Healing Cancer: A Homoeopathic Approach” by Dr Farokh J Master, does not endorse a focused methodology, but it paves the way to a holistic homoeopath’s approach. For the last 40 years, the author has been utilising this approach which is in line with the Master Hahnemann’s teachings, where he gives importance to constitution, miasms, susceptibility, and most important palliation. It is a complete handbook, a ready reference providing authentic information on every aspect of malignant diseases. It covers the cancer related topics beginning from cancer archetype, clinical information on diagnosis, prevention, conventional treatment, homoeopathic aspects, therapeutics, polycrest remedies, rare remedies, Indian remedies, wisdom from the repertory, naturopathic and dietary suggestions, Iscador therapy, and social aspects of cancer to the latest researches in the field of cancer. Given the efforts put in by the author in writing this vast book, encompassing decades of clinical experience, this is indeed a valuable addition to the homoeopathic literature. In addition to homoeopaths, this book will indeed be useful for medical doctors of other modalities of therapeutics who also wish to explore a holistic approach to cancer patients since this book is the outcome of author’s successful efforts in introducing and integrating homoeopathy to the mainstream cancer treatment.
END OF QUOTE
I do wonder what goes on in the head of a clinician who spent much of his life convincing himself and others that his placebos cure cancer and then takes it upon him to write a book about this encouraging other clinician to follow his dangerous ideas.
Is he vicious?
Is he in it for the money?
Is he stupid?
Is he really convinced?
Whatever the answer, he certainly is dangerous!
For those who do not know already: homeopathy is totally ineffective as a treatment for cancer; to think otherwise can be seriously harmful.
A few weeks ago, I was interviewed by a journalist who wanted to publish the result in a magazine. He now informed me that his editor decided against it, and the interview thus remained unpublished. I have the journalist’s permission to publish it here. The journalist who, in my view, was well-prepared (much better than most), prefers to remain unnamed.
Q: How would you describe yourself?
A: I am a researcher of alternative medicine.
Q: Not a critic of alternative medicine?
A: Primarily, I am a researcher; after all, I have published more Medline-listed research papers on the subject than anyone else on the planet.
Q: You are retired since a few years; why do you carry on working?
A: Mainly because I see a need for a critical voice amongst all the false and often dangerous claims made by proponents of alternative medicine. But also because I enjoy what I am doing. Since I retired, I can focus on the activities I like. There is nobody to tell me what to do and what not to do; the latter happened far too often when I was still head of my research unit.
Q: Fine, but I still do not quite understand what drives you. Who is motivating you to criticise alternative medicine?
A: Nobody. Some people claim I am paid for my current activities. This is not true. My blog actually costs me money. My books never return enough royalties to break even, considering the time they take to write. And for most of my lectures I don’t charge a penny.
Q: There are people who find this hard to believe.
A: I know. This just shows how money-orientated they are. Do they want me to publish my tax returns?
Q: Sorry, but I still don’t understand your motivation.
A: I guess what motivates me is a sense of responsibility, a somewhat naïve determination to do something good as a physician. I am one of the only – perhaps even THE only – scientist who has researched alternative medicine extensively and who is not a promoter of bogus therapies but voices criticism about them. There are several other prominent and excellent critics of alternative medicine, of course, but they all come ‘from the outside’. I come from the inside of the alternative medicine business. This probably gives me a special understanding of this field. In any case, I feel the responsibility to counter-balance all the nonsense that is being published on a daily basis.
Q: What’s your ultimate aim?
A: I want to create progress through educating people to think more critically.
Q: Which alternative medicine do you hate most?
A: I do not hate any of them. In fact, I still have more sympathy for them than might be apparent. For my blog, for instance, I constantly search for new research papers that are rigorous and show a positive result. The trouble is, there are so very few of those articles. But when I find one, I am delighted to report about it. No, I do not hate or despise any alternative medicine; I am in favour of good science, and I get irritated by poor research. And yes, I do dislike false claims that potentially harm consumers. And yes, I do dislike it when chiropractors or other charlatans defraud consumers by taking their money for endless series of useless interventions.
Q: I noticed you go on about the risks of alternative medicine. But surely, they are small compared to the risks of conventional healthcare, aren’t they?
A: That’s a big topic. To make it simple: alternative medicine is usually portrayed as risk-free. The truth, however, is that there are numerous risks of direct and indirect harm; the latter is usually much more important than the former. Crucially, the risk-free image is incongruent with reality. I want to redress this incongruence. And as to conventional medicine: sure, it can be much more harmful. But one always has to see this in relation to the proven benefit. Chemotherapy, for instance, can kill a cancer patient, but more likely it saves her life. Homeopathic remedies cannot kill you, but employed as an alternative to an effective cancer treatment, homeopathy will certainly kill you.
Q: Homeopathy seems to be your particular hobby horse.
A: Perhaps. This is because it exemplifies alternative medicine in several ways, and because I started my alternative ‘career’ in a homeopathic hospital, all those years ago.
Q: In what way is homeopathy exemplary?
A: Its axioms are implausible, like those of many other alternative modalities. The clinical evidence fails to support the claims, like with so many alternative therapies. And it is seemingly safe, yet can do a lot of harm, like so many other treatments.
Q: You have no qualification in homeopathy, is that right?
A: No, I have no such qualifications. And I never said so. When I want to tease homeopaths a little, I state that I am a trained homeopath; and that is entirely correct.
Q: In several countries, homeopathy has taken spectacular hits recently. Is that your doing?
A: No, I don’t think so. But I do hope that my work has inspired the many dedicated activists who are currently protesting against the reimbursement of homeopathy by the public purse in the UK, Germany, France, Spain, etc.
Q: You often refer to medical ethics; why is that?
A: Because, in the final analysis, many of the questions we already discussed are really ethical issues. And in alternative medicine, few people have so far given the ethical dimensions any consideration. I think ethics are central to alternative medicine, so much so that I co-authored an entire book on this topic this year.
Q: Any plans for the future?
Q: Can you tell me more?
A: I will publish another book in 2019 with Springer. It will be a critical evaluation of precisely 150 different alternative modalities. I am thinking of writing yet another book, but have not yet found a literary agent who wants to take me on. I have been offered a new professorship at a private University in Vienna, and am hesitant whether to accept or not. I have been invited to give a few lectures in 2019 and hope to receive more invitations. Last not least, I work almost every day on my blog.
Q: More than enough for a retiree, it seems. Thank you for your time.
A: My pleasure.
Many chiropractors tell new mothers that their child needs chiropractic adjustments because the birth is in their view a trauma for the new-born that causes subluxations of the baby’s spine. Without expert chiropractic intervention, they claim, the poor child risks serious developmental disorders.
This article (one of hundreds) explains it well: Birth trauma is often overlooked by doctors as the cause of chronic problems, and over time, as the child grows, it becomes a thought less considered. But the truth is that birth trauma is real, and the impact it can have on a mother or child needs to be addressed. Psychological therapy, physical therapy, chiropractic care, acupuncture, and other healing techniques should all be considered following an extremely difficult birth.
And another article makes it quite clear what intervention is required: Caesarian section or a delivery that required forceps or vacuum extraction procedures, in-utero constraint, an unusual presentation of the baby, and many more can cause an individual segment of the spine or a region to shift from its normal healthy alignment. This ‘shift’ in the spine is called a Subluxation, and it can happen immediately before, during, or after birth.
Thousands of advertisements try to persuade mothers to take their new-born babies to a chiropractor to get the problem sorted which chiropractors often call KISS (kinetic imbalance due to suboccipital strain-syndrome), caused by intrauterine-constraint or the traumas of birth.
This abundance of advertisements and promotional articles is in sharp contrast with the paucity of scientific evidence.
A review of 1993 concluded that birth trauma remains an underpublicized and, therefore, an undertreated problem. There is a need for further documentation and especially more studies directed toward prevention. In the meantime, manual treatment of birth trauma injuries to the neuromusculoskeletal system could be beneficial to many patients not now receiving such treatment, and it is well within the means of current practice in chiropractic and manual medicine.
A more critical assessment of … concluded that, given the absence of evidence of beneficial effects of spinal manipulation in infants and in view of its potential risks, manual therapy, chiropractic and osteopathy should not be used in infants with the kinetic imbalance due to suboccipital strain-syndrome, except within the context of randomised double-blind controlled trials.
So, what follows from all this?
How about this?
Chiropractors’ assumption of an obligatory birth trauma that causes subluxation and requires spinal adjustments is nothing more than a ploy by charlatans for filling their pockets with the cash of gullible parents.
This systematic review was aimed at evaluating the effects of acupuncture on the quality of life of migraineurs. Only randomized controlled trials that were published in Chinese and English were included. In total, 62 trials were included for the final analysis; 50 trials were from China, 3 from Brazil, 3 from Germany, 2 from Italy and the rest came from Iran, Israel, Australia and Sweden.
Acupuncture resulted in lower Visual Analog Scale scores than medication at 1 month after treatment and 1-3 months after treatment. Compared with sham acupuncture, acupuncture resulted in lower Visual Analog Scale scores at 1 month after treatment.
The authors concluded that acupuncture exhibits certain efficacy both in the treatment and prevention of migraines, which is superior to no treatment, sham acupuncture and medication. Further, acupuncture enhanced the quality of life more than did medication.
The authors comment in the discussion section that the overall quality of the evidence for most outcomes was of low to moderate quality. Reasons for diminished quality consist of the following: no mentioned or inadequate allocation concealment, great probability of reporting bias, study heterogeneity, sub-standard sample size, and dropout without analysis.
Further worrisome deficits are that only 14 of the 62 studies reported adverse effects (this means that 48 RCTs violated research ethics!) and that there was a high level of publication bias indicating that negative studies had remained unpublished. However, the most serious concern is the fact that 50 of the 62 trials originated from China, in my view. As I have often pointed out, such studies have to be categorised as highly unreliable.
In view of this multitude of serious problems, I feel that the conclusions of this review must be re-formulated:
Despite the fact that many RCTs have been published, the effect of acupuncture on the quality of life of migraineurs remains unproven.
The UK media have often disappointed me when reporting about matters related to alternative medicine. Yet, this is ‘small fry’ compared to their coverage of the EU during the last decades. Here I have selected 50 (there are plenty more) headlines from a long list of ‘alternative truths’ and Euromyths of their invented or misleading healthcare-related stories:
- New EU sulphur rules will cause problems with oil-fired Aga’s, Dec 2009
- EU ‘bans boozing’, Feb 2005
- UK diners will face £200m for EU allergen rules, Nov 2014
- False alarm over 999 calls, Dec 2006
- Ambulances turn yellow for Europe, Mar 2002
- EU to force St Johns Ambulances to replace its entire fleet, Apr 2002
- Human medicines to be forbidden for use on animals, Feb/Mar 1995
- Taxpayers money used to rehabilitate Peruvian drug addicts, Jul 2014
- EU bans children from blowing up balloons, Oct 2011
- EU health directive to prevent barmaids from showing cleavage, Nov 2005
- “EU red tape” is denying cancer patients access to new treatments, Jun 2016
- EC rules on levels of listeria threaten British cheeses, Feb 1995
- Sales of cigars to fall due to be sold individually with a health warning, Jan 1994
- Circus performers required to wear hard hats, Jul 2003
- EU responsible for your hay fever, May 2015
- Condom dimensions to be harmonised, Mar 2000
- Fishing boats obliged to carry condoms, Nov 1992
- EU to push for standard condom size, Oct 1994
- EU plans to liquify corpses and pour them down the drain, July 2010
- Traditional cricket teas will be subjected to random hygiene checks, Apr 1993
- EC to ban prawn cocktail crisps, Jan 1993
- Smoky bacon crisps to be banned, May 2003
- EU outlaws teeth whitening products, Feb 2003
- EU blocking vital checks on doctors’ qualifications, Apr 2016
- EU doctors in UK a threat to patients, Sep 2016
- UK hospital have to employ people who do not speak English, Apr 2012
- Hundreds of GPs to be forced to acquire additional qualifications, Sep 1994
- 58 hour working week will ground hospitals to a halt, Aug 2004
- UK doctors unable to treat off shore patients at night, Feb 1999
- HGV drivers not permitted to wear glasses, Feb 1996
- Regulators to set maximum heat of electric blankets, leaving pensioners cold, Oct 1993
- Organic farmers ordered by EU to use homeopathic medicine, Apr 2015
- Small inshore fishing boats to be forced to carry extensive medical kits, Dec 1994
- Rare meat to be banned due to “too much bacteria”, Sep 1993
- Street vendors face closure due to an EC food hygiene Directive, Nov 1992
- EC to stop UK citizens taking extra strong multi-vitamin pills, Feb 1993
- EU rights to reside in another member state, EU benefit claimants and NHS treatment entitlement, Feb 2013
- Brussels to ban herbal cures, Mar 1999
- License to be required to sell herbal medicines, Oct 1994
- Update on whether license to be required to sell herbal medicines, Nov 1994
- Horses to no longer receive medicine that would make them unsafe for consumption, Jan 1994
- Hysteria about listeria, Feb 1995
- European Commission approve unsafe high-risk medical devices, Jul 2016
- Medicines to receive Latin labelling, May 1999
- Soya milk indistinguishable from cow milk and thus to be banned, April 1995
- Scotch whisky must be handled as a dangerous chemical, Nov 1995
- EC hygiene rules force closure of abattoirs, Nov 1992
- EU ban on ciggie breaks? Just hot air, Jun 2007
- Brussels to reinstate tobacco subsidies, Feb 2013
- EU to ban vitamin supplements, Mar 2002
Yes, some of this is so nonsensically idiotic that it could be quite funny.
But sadly, it is also very annoying, even infuriating. I am sure these relentless lies are partly the cause why Brexit is currently dividing the UK and threatening to become a monumental exercise in self-destruction.
On Twitter and elsewhere, homeopaths have been celebrating: FINALLY A PROOF OF HOMEOPATHY HAS BEEN PUBLISHED IN A TOP SCIENCE JOURNAL!!!
Here is just one example:
#homeopathy under threat because of lack of peer reviewed studies in respectable journals? Think again. Study published in the most prestigious journal Nature shows efficacy of rhus tox in pain control in rats.
But what exactly does this study show (btw, it was not published in ‘Nature’)?
The authors of the paper in question evaluated antinociceptive efficacy of Rhus Tox in the neuropathic pain and delineated its underlying mechanism. Initially, in-vitro assay using LPS-mediated ROS-induced U-87 glioblastoma cells was performed to study the effect of Rhus Tox on reactive oxygen species (ROS), anti-oxidant status and cytokine profile. Rhus Tox decreased oxidative stress and cytokine release with restoration of anti-oxidant systems. Chronic treatment with Rhus Tox ultra dilutions for 14 days ameliorated neuropathic pain revealed as inhibition of cold, warm and mechanical allodynia along with improved motor nerve conduction velocity (MNCV) in constricted nerve. Rhus Tox decreased the oxidative and nitrosative stress by reducing malondialdehyde (MDA) and nitric oxide (NO) content, respectively along with up regulated glutathione (GSH), superoxide dismutase (SOD) and catalase activity in sciatic nerve of rats. Notably, Rhus Tox treatment caused significant reductions in the levels of tumor necrosis factor (TNF-α), interleukin-6 (IL-6) and interleukin-1β (IL-1β) as compared with CCI-control group. Protective effect of Rhus Tox against CCI-induced sciatic nerve injury in histopathology study was exhibited through maintenance of normal nerve architecture and inhibition of inflammatory changes. Overall, neuroprotective effect of Rhus Tox in CCI-induced neuropathic pain suggests the involvement of anti-oxidative and anti-inflammatory mechanisms.
END OF QUOTE
I am utterly under-whelmed by in-vitro experiments (which are prone to artefacts) and animal studies (especially those with a sample size of 8!) of homeopathy. I think they have very little relevance to the question whether homeopathy works.
But there is more, much more!
It has been pointed out that there are several oddities in this paper which are highly suspicious of scientific misconduct or fraud. It has been noted that the study used duplicated data figures that claimed to show different experimental results, inconsistently reported data and results for various treatment dilutions in the text and figures, contained suspiciously identical data points throughout a series of figures that were reported to represent different experimental results, and hinged on subjective, non-blinded data from a pain experiment involving just eight rats.
Lastly, others pointed out that even if the data is somehow accurate, the experiment is unconvincing. The fast timing differences of paw withdraw is subjective. It’s also prone to bias because the researchers were not blinded to the rats’ treatments (meaning they could have known which animals were given the control drug or the homeopathic dilution). Moreover, eight animals in each group is not a large enough number from which to draw firm conclusions, they argue.
As one consequence of these suspicions, the journal has recently added the following footnote to the publication:
10/1/2018 Editors’ Note: Readers are alerted that the conclusions of this paper are subject to criticisms that are being considered by the editors. Appropriate editorial action will be taken once this matter is resolved.
WATCH THIS SPACE!
Evening primrose oil (EPO) is amongst the best-selling herbal remedies of all times. It is marketed in most countries as a dietary supplement. It is being promoted for eczema, rheumatoid arthritis, premenstrual syndrome, breast pain, menopause symptoms, and many other conditions. EPO seems to be a prime example for the fact that, in alternative medicine, the commercial success of a remedy is not necessarily determined by the strength of the evidence but by the intensity and cleverness of the marketing activities.
Evening primrose oil has been extensively tested in clinical trials for a wide range of conditions, including eczema (atopic dermatitis), postmenopausal symptoms, asthma, psoriasis, cellulite, hyperactivity, multiple sclerosis, schizophrenia, obesity, chronic fatigue syndrome, rheumatoid arthritis, and mastalgia. As I have reported previously, these data were burdened with mischief and scientific misconduct, and it is therefore not easy to differentiate between science, pseudoscience and fraud. The results of the more reliable investigations fail to show that it is effective for any condition. A Cochrane review of 2013, for instance, concluded that supplements of evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials.
But now, a new study has emerged that casts doubt on this conclusion. The aim of this double-blinded, placebo-controlled RCT is to evaluate the efficacy and safety of EPO in Korean patients with atopic dermatitis (AD).
Fifty mild AD patients with an Eczema Area Severity Index (EASI) score of 10 or less were randomly divided into two groups. The first group received an oval unmarked capsule containing 450 mg of EPO (40 mg of GLA) per capsule, while placebo capsules identical in appearance and containing 450 mg of soybean oil were given to the other group. Treatment continued for a period of 4 months. EASI scores, transepidermal water loss (TEWL), and skin hydration were evaluated in all the AD patients at the baseline, and in months 1, 2, 3, and 4 of the study.
At the end of month 4, the patients of the EPO group showed a significant improvement in the EASI score, whereas the patients of the placebo group did not. There was a significant difference in the EASI score between the EPO and placebo groups. Although not statistically significant, the TEWL and skin hydration also slightly improved in the EPO patients group. Adverse effect were not found in neither the experimental group nor the control group during the study period.
The authors concluded by suggesting that EPO is a safe and effective medicine for Korean patients with mild AD.
I find this study odd for several reasons:
- One cannot possibly draw conclusions based on such a small sample.
- The authors state that a total of 69 mild AD patients were enrolled and randomized into either the control group (14 males and 17 females) or the EPO group (20 males and 18 females). Six patients in the control group and 13 patients in the EPO group dropped out due to follow up loss. No patient dropped out because the disease worsened. Should this not have necessitated an intention-to-treat analysis? And, if 19 patients were lost to follow-up, how do the authors know that their disease did not worsen?
- The graph shows impressively the lack of a placebo-response. I don’t understand why there was none.
- The authors state that there were no adverse effects at all. I find this implausible; we know that even taking placebos will prompt patients to report adverse effects.
So, what to make out of this?
I am not at all sure, but one thing is certain: this study does not alter my verdict on EPO; as far as I am concerned, the effectiveness of EPO for AD is unproven.
Traditional Chinese Medicine (TCM) is the umbrella term for modalities historically used in ancient China. TCM includes many therapeutic and some diagnostic modalities. Even though, these modalities differ in many respects, they are claimed to have in common that they are based on assumptions most of which originate from Taoist philosophy:
- The human body is a miniature version of the universe.
- Harmony between the two opposing forces, yin and yang, means health.
- Disease is caused by an imbalance between these forces.
- Five elements—fire, earth, wood, metal, and water—symbolically represent all phenomena, including the stages of human life, and explain the functioning of the body and how it changes during disease.
- The vital energy, qi or chi, flows through the body in meridians, is essential for maintaining health.
TCM is a construct of Mao Zedong who lumped all historical Chinese treatments together under this umbrella and created the ‘barefoot doctor’ to practice TCM nationwide – not because he believed in TCM, but because China was desperately short of real doctors and needed at least a semblance of healthcare.
Over the past few years, China has been aggressively promoting TCM for expanding its global influence and for a share of the estimated US$50-billion global market (of products of dubious quality). A recent article in ‘Nature’ explains that the WHO’s governing body, the World Health Assembly, is set to adopt the 11th version of the organization’s global compendium — known as the International Statistical Classification of Diseases and Related Health Problems (ICD). For the first time, the ICD will include information about TCM. Chapter 26 of the ICD will feature a classification system on TCM, largely based not on science or facts, but on obsolete nonsense.
The WHO’s support applies to all traditional medicines, but its relationship with Chinese medicine, and with China, has grown especially close, in particular during the tenure of Margaret Chan, who ran the organization from 2006 to 2017 and made sure that several documents favourable to TCM were passed. The WHO’s declarations about traditional medicine are puzzling. Various of these WHO documents call for the integration of “traditional medicine, of proven quality, safety and efficacy”, while being silent as to which traditional medicines and diagnostics are proven. Wu Linlin, a WHO representative in the Beijing office, told Nature that the “WHO does not endorse particular traditional and complementary medicine procedures or remedies”.
But this is evidently not the case and in sharp contrast to the WHO’s actions in other areas. The agency provides, for instance, specific advice on what vaccines and drugs to use and what foods to avoid. With traditional medicines, however, such specifics are missing. The message therefore can only be that the WHO endorses TCM as safe and effective.
The evidence, however, tells us a different story. On this blog, we have repeatedly discussed that:
- the clinical trials of TCM are often of poor quality,
- there are several good reasons why one has to be very sceptical about research coming out of China,
- critics are silenced,
- in general, the evidence on TCM is neither positive nor trustworthy.
China’s drug regulator gets more than 230,000 reports of adverse effects from TCM each year, and Chinese herbal medicines carry multiple direct risks:
- one or more ingredients can be toxic,
- some have been shown to be contaminated with toxic materials such as heavy metals,
- others are adulterated with synthetic drugs such as steroids,
- others again can interact with prescription drugs taken concomitantly,
- and not to forget, the risk for endangered species.
To this, we have to add the indirect risk of employing useless treatments for otherwise treatable conditions.
In view of all this, the WHO’s endorsement of TCM and its obsolete concepts is not just not understandable, it is a dangerous step backwards and, in my view, even intolerable.