placebo
I was alerted to a new book entitled “Handbook of Space Pharmaceuticals“. It contains a chapter on “Homeopathy as a Therapeutic Option in Space” (yes, I am not kidding!). Here is its abstract (the numbers were inserted by me and refer to the short comments below):
Homeopathy is one of the largest used unorthodox medicinal systems having a wide number of principles and logic to treat and cure various diseases [1]. Many successful concepts like severe dilution to high agitation have been applied in the homeopathic system [2]. Though many concepts like different treatment for same diseases and many more are contradictory to the allopathic system [3], homeopathy has proved its worth in decreasing drug-related side effects in many arenas [4]. Various treatments and researches are carried out on various diseases; mostly homeopathic treatment is used in joint diseases, respiratory diseases, cancer, and gastrointestinal tract diseases [5]. In this chapter, readers will have a brief idea about many meta-analysis results of most common respiratory diseases, i.e., asthma, incurable hypertension condition, rheumatoid arthritis, and diarrhea and a megareview of all the diseases to see their unwanted effects, uses of drugs, concepts, and issues related to homeopathy [6]. Various limitations of homeopathic treatments are also highlighted which can give a clear idea about the future scope of research [7]. Overall, it can be concluded that placebo and homeopathic treatments give almost the same effect [8], but the less severe side effects of homeopathic drugs in comparison to all other treatment groups catch great attention [9].
Apart from the very poor English of the text and the fact that it has as good as nothing to do with the subject of ‘Homeopathy as a Therapeutic Option in Space’, I have the following brief comments:
- I did not know that homeopathy has ‘a wide number of logic’ and had alwas assumed that there is only one logic.
- Successful concepts? Really?
- So, homeopaths believe that the ‘allopathic system’ treats the same diseases uniformly? In this case, they should perhaps read up what conventional medicine really does.
- I am not aware of good evidence showing that homeopathy reduces drug related adverse effects.
- No, homeopathy is used for all symptoms – Hahnemann did not believe in treating disease entities – and mostly for those that are self-limiting.
- I love the term ‘incurable hypertension condition’; can somebody please explain what it is?
- The main limitation is that homeopathy is nonsense and, as such, does not really require further research.
- Not ‘almost’ but ‘exactly’! But thanks for pointing it out.
- Wishful thinking and not true. Firstly, the author forgot about ‘homeopathic aggravations’ in which homeopaths so strongly believe. Secondly, I know of many non-homeopathic treatments that are free of adverse effects when done properly.
Altogether, I am as disappointed by this article as you must be: we were probably all hoping to hear about the discovery showing that homeopathy works splendidly in space – not least because we have known for a while that homeopaths seem to be from a different planet.
On the occasion of a talk that I recently gave in Italy, I was interviewed by VANITY FAIR ITALY. I gave it in English and it was published in Italian. As I don’t expect many readers to be fluent in Italian and since it was a good interview, in my view, I thought I give you here the English original:
1.How can we exactly define «alternative medicine»?
There is much confusion and a plethora of definitions, none of which is fully satisfactory. In fact, the term “alternative medicine” itself is nonsensical: if a therapy works, it belongs to evidence-based medicine; and if it doesn’t work, it cannot possibly be an alternative. I therefore have long been calling it “so-called alternative medicine” (SCAM). The definition I use for SCAM with lay audiences is simple: SCAM is an umbrella term for a diverse range of therapeutic and diagnostic methods that have little in common, other than being excluded from mainstream medicine.
2.Who uses it and why?
Predominantly women! Statistics say about 30-70% of the general population use SCAM. And with patient populations, the percentage can be close to 100%. They use it because they are told over and over again that SCAM is natural and thus safe, as well as effective for all sorts of conditions.
3.Focusing on terminology, is there a difference between «complementary» and «alternative» medicine?
Theoretically, there is a big difference between «complementary» and «alternative» medicine. The former is supposed to be used as an add-on to, while the latter is a replacement of mainstream medicine. In practice, this dividing line is very blurred; most SCAMs are used in both ways, depending on the actual situation and circumstance.
4.Are users different from non-users?
Yes, there has been much research on this and my reading of it is that SCAM users tend to be less intelligent, more religious, more superstitious, less trusting in science, and more prone to conspiracy theories, for instance.
5.Which forms of alternative medicine are the most popular?
There are certain national differences, but in most European countries herbal medicine, acupuncture, chiropractic, osteopathy, homeopathy, aromatherapy, and reflexology are amongst the most popular SCAMs.
6.Does it work?
With such a wide range – someone once counted over 400 modalities and my last book evaluated 202 of them (Alternative Medicine: A Critical Assessment of 202 Modalities (Copernicus Books): Amazon.co.uk: Ernst, Edzard: 9783031107092: Books) – it is impossible to answer with yes or no. In addition we need to consider the conditions that are being treated. Acupuncture, for example, is touted as a panacea, but might just work for pain. If you take all this into account, I estimate that less than 3% of the therapeutic claims that are being made for SCAM are supported by sound evidence.
Is it safe?
Again, impossible to say. Some treatments are outright dangerous; for instance, chiropractic neck manipulations can injure an artery and the patient suffers a stroke of which she can even die. Other treatments are assumed to be entirely harmless; for example homeopathy. But even that is untrue: if a cancer patient relies exclusively on homeopathy for a cure, she might easily hasten her death. Sadly, such things happen not even rarely.
Do its benefits outweigh its risks?
That depends very much on the treatment, the disease, and the precise situation. Generally speaking, there are very few SCAMs that fulfill this condition.
You said that these were the research questions that occupied all your life in Exeter. Did you find the answers?
We published more on SCAM than any other research group, and we found mostly disappointing answers. But still, I am proud of having found at least some of the most pressing answers. Even negative answers can make an important contribution to our knowledge.
7.What is the problem with the placebo effect?
All therapies can prompt a placebo effect. Thus an ineffective treatment can easily appear to be effective through generating a placebo effect. This is why we need to rely on properly conducted, if possible placebo-controlled trials, if we want to know what works and what not.
8.Is it true that some alternative medicines can cause significant harm?
see above
9.What about herbal remedies? What do studies show about them?
Many of our modern drugs originate from plants, Therefore, it is not surprising that we find herbal remedies that are effective. But careful! This also means that plants can kill you – think of hemlock, for instance. In addition herbal medicine can interact powerfully with synthetic drugs. So, it is wise to be cautious and get responsible advice.
10.Which alternative therapies are overrated and why?
In my view, almost all SCAMs are over-rated. If you go on the Internet, you find ~5 000 000 websites on SCAM. 99% of them try to sell you something and are unreliable or even dangerous. We need to be aware of the fact that SCAM has grown into a huge business and many entrepreneurs are out to get your money based on bogus claims.
11.On the contrary, which therapies could be seen as an integration in routine care?
The best evidence can be found in the realm of herbal medicine, for instance St John’s Wort. Some mind-body interventions can be helpful; also a few massage techniques might be worth a try. Not a lot, I’m afraid.
12.Would you tell us what happened in 2005 with Prince Charles?
He complained about my actions via his private secretary to my University. A 13 month investigation followed. At the end, I was found not guilty but my funding, my team, my infrastructure had been dismantled. So, in effect, Charles managed to close down what was the only research group that looked critically and systematically into SCAM. A sad story – not so much for me but for progress and science, I think.
3.Why is alternative medicine still a controversial subject?
Mainly because the gap between the claims and the evidence is so very wide – and getting wider all the time.
14.Would you suggest the «right way» to approach it?
I often recommend this: if it sounds too good to be true, it probably is! I might add that, if you want reliable advice, don’t listen to those who profit from giving it.
This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.
A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.
The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.
As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:
- regression towards the mean;
- natural history of the condition;
- success of patient blinding;
- social desirability.
To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.
In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.
This study evaluated the effect of ear acupressure (auriculotherapy) on the weight-gaining pattern of overweight women during pregnancy. It was a single-blinded randomized clinical trial conducted between January and September 2022 and took place in health centers of Qom University of Medical Sciences in Iran.
One-hundred thirty overweight pregnant women were selected by a purposeful sampling method and then divided into two groups by block randomization method. In the intervention group, two seeds were placed in the left ear on the metabolism and stomach points, while two seeds were placed in the right ear on the mouth and appetite points. Participants in the intervention group were instructed to press the seeds six times a day, 20 minutes before a meal for five weeks. For the placebo group, the Vaccaria seedless label was placed at the same points as the intervention group.
A digital scale with an accuracy of 0.1 kg was used to weigh the pregnant women during each visit. Descriptive statistics, independent T-test, chi-square, and repeated measure ANOVA (analysis of variance) test were used to check the research objectives.
There was a statistically significant difference between the auriculotherapy and placebo groups immediately after completing the study (1120.68 ± 425.83 vs. 2704.09 ± 344.96 (g); = 0.018), respectively. Also, there was a substantial difference in the weight gain of women two weeks (793.10 ± 278.38 vs. 1090.32 ± 330.31 (g); < 0.001) and four weeks after the intervention (729.31 ± 241.52 vs. 964.51 ± 348.35 (g); < 0.001) between the auriculotherapy and placebo groups.
The authors concluded that the results of the present study indicated the effectiveness of auriculotherapy in controlling the weight gain of overweight pregnant women. This treatment could be used as a safe method, with easy access, and low cost in low-risk pregnancies.
In order to understand these findings, it is worth reading the methods section of the paper. It explains what actually happened with the two groups:
After providing explanations to familiarize the participants with the working method and answering their questions, the participants were requested to be comfortable. The first author who has an auriculotherapy certificate did the intervention. The intervention began by disinfecting both ears with a 70% alcohol solution. After determining the location of metabolism and stomach points in the left ear and mouth and appetite points in the right ear related to weight and appetite control, the researcher placed the seeds on the desired points… The intervention lasted for a total of 5 weeks. The seeds were changed twice a week (once every three days) by the researcher. The participants in the intervention group were taught to press the seeds 6 times a day for one minute each time. The pressure method was to use moderate stimulation with continuous pressure. In the first session, the researcher fully taught the participants the amount of pressure and the duration of it in a practical way and asked them to do this once in her presence to ensure that it was correct. Participants were recommended to do this preferably 20 minutes before eating. The researcher reminded the participants in the intervention group of their daily interventions by phone or text message. Each night, they were asked to check if they had followed the instructions and completed the daily registration checklist. In each seed replacement session, which was performed every three days, the checklist of the previous session was viewed and checked, and a checklist was received every week at the same time as the participants were weighed. Subjects were also emphasized in case of any symptoms of allergies or infections and pain as soon as possible through the contact number provided to them to discuss the issue with the researcher to remove the seeds.
In the placebo group, instead of real seeds, a label without Vaccaria seed (waterproof fabric adhesive) was placed by the researcher at the desired points in both ears, and the participants did not receive training to compress the points. They also did not receive the list of daily pressing points. All follow-ups and replacement of labels were performed in the same way as the intervention group in the placebo group. Finally, all participants were requested to notify the researcher if any seeds or labels were removed for any reason. It should be noted that pregnant mothers were unaware of the nature of the group to which they belonged.
It seems clear, therefore, that the patients were NOT blinded and that the verum patients received different care and more attention/encouragement than the placebo group. This means firstly that the trial was NOT single-blind, as the authors claim. Secondly, it means that the outcomes were most likely NOT due to ear acupressure at all – they were caused by the non-specific effects of expectation, extra attention, etc. which, in turn, motivated the women to better control their weight. Consequently, the conclusions of this study should be re-phrased:
The results of the present study fail to indicate the effectiveness of auriculotherapy in controlling the weight gain of overweight pregnant women.
In addition, I feel that the researchers, supervisors, peer-reviewers, editors should all bow their heads in shame for trying to mislead us.
This case report aims to describe the effects of craniosacral therapy and acupuncture in a patient with chronic migraine.
A 33-year-old man with chronic migraine was treated with 20 sessions of craniosacral therapy and acupuncture for 8 weeks. The number of migraine and headache days were monitored every month. The pain intensity of headache was measured on the visual analog scale (VAS). Korean Headache Impact Test-6 (HIT-6) and Migraine Specific Quality of Life (MSQoL) were also used.
The number of headache days per month reduced from 28 to 7 after 8 weeks of treatment and to 3 after 3 months of treatment. The pain intensity of headache based on VAS reduced from 7.5 to 3 after 8 weeks and further to < 1 after 3 months of treatment. Furthermore, the patient’s HIT-6 and MSQoL scores improved during the treatment period, which was maintained or further improved at the 3 month follow-up. No side effects were observed during or after the treatment.
The authors concluded that this case indicates that craniosacral therapy and acupuncture could be effective treatments for chronic
migraine. Further studies are required to validate the efficacy of craniosacral therapy for chronic migraine.
So, was the treatment period 8 weeks long or was it 3 months?
No, I am not discussing this article merely for making a fairly petty point. The reason I mention it is diffteren. I think it is time to discuss the relevance of case reports.
What is the purpose of a case report in medicine/healthcare. Here is the abstract of an article entitled “The Importance of Writing and Publishing Case Reports During Medical Training“:
Case reports are valuable resources of unusual information that may lead to new research and advances in clinical practice. Many journals and medical databases recognize the time-honored importance of case reports as a valuable source of new ideas and information in clinical medicine. There are published editorials available on the continued importance of open-access case reports in our modern information-flowing world. Writing case reports is an academic duty with an artistic element.
An article in the BMJ is, I think, more informative:
It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.
It usually falls to the junior to write up the case, so here are a few simple tips to get you started.
First steps
Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.
Getting consent
Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.
Information gathering
Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.
Writing up
Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.
Coming up with a title
Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.
Background research
Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.
How your case is different
Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.
Conclusion
Finish by explaining why your case report adds to the medical literature and highlight any learning points.
Writing an abstract
The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.
What next
Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!
Both papers agree that case reports can be important. They may provide valuable resources of unusual information that may lead to new research and advances in clinical practice and should offer an interesting case with an unusual presentation or a surprise twist.
I agree!
But perhaps it is more constructive to consider what a case report cannot do.
It cannot provide evidence about the effectiveness of a therapy. To publish something like:
- I had a patient with the common condition xy;
- I treated her with therapy yz;
- this was followed by patient feeling better;
is totally bonkers – even more so if the outcome was subjective and the therapy consisted of more than one intervention, as in the article above. We have no means of telling whether it was treatment A, or treatment B, or a placebo effect, or the regression towards the mean, or the natural history of the condition that caused the outcome. The authors might just as well just have reported:
WE RECENTLY TREATED A PATIENT WHO GOT BETTER
full stop.
Sadly – and this is the reason why I spend some time on this subject – this sort of thing happens very often in the realm of SCAM.
Case reports are particularly valuable if they enable and stimulate others to do more research on a defined and under-researched issue (e.g. an adverse effect of a therapy). Case reports like the one above do not do this. They are a waste of space and tend to be abused as some sort of indication that the treatments in question might be valuable.
The US ‘Public Citizen‘ is an American non-profit, progressive consumer rights advocacy group, and think tank based in Washington, D.C. They recently published an article entitled “FDA Guidance on Homeopathic Drugs: An Ongoing Public Health Failure“. Here are a few excerpts:
In December 2022, the U.S. Food and Drug Administration (FDA) issued new guidance on homeopathic drug products. The guidance states that the agency now “intends to apply a risk-based enforcement approach to the manufacturing, distribution and marketing of homeopathic drug products.”
Under this new risk-based approach, the agency plans to target its enforcement actions against homeopathic drug products marketed without FDA approval that fall within the following limited categories:
- products with reports of injury that, after evaluation, raise potential safety concerns
- products containing or purportedly containing ingredients associated with potentially significant safety concerns (for example, infectious agents or controlled substances)
- products that are not administered orally or topically (for example, injectable drug products and ophthalmic drug products)
- products intended to be used to prevent or treat serious or life-threatening diseases
- products for vulnerable populations, such as immunocompromised individuals, infants and the elderly
- products with significant quality issues (for example, products that are contaminated with foreign materials or objectionable microorganisms)
But this new FDA guidance fails to adequately address the public health threat posed by the agency’s decades-long permissive approach to these illegal drug products.
Under FDA regulations, prescription and over-the-counter (OTC) homeopathic products are considered drugs and are supposed to be subject to the same review and approval requirements as all other prescription and OTC medications. However, under a flawed enforcement policy issued in 1988, the FDA has allowed these drug products to be marketed in the U.S. without agency review or approval. Thus, all products labeled as homeopathic are being marketed without the FDA having evaluated their safety, effectiveness or quality…
… there is no plausible physiologic or medical basis to support the theory underlying homeopathy, nor is there evidence from well-designed, rigorous clinical trials showing that homeopathic drugs are safe and effective.
The FDA should declare unequivocally that all unapproved homeopathic drug products are illegal and direct all manufacturers to immediately remove such products from the market. In the meantime, as we have recommended for many years, consumers should not use homeopathic products. At best, the products are a waste of money, given the lack of any evidence that they are effective. At worst, they could cause serious harm because of the lack of FDA oversight to ensure safety.
_____________________
I fully agree with these sentiments. The harm caused by homeopathy is considerable and multi-facetted. Many previous posts have discudded these problems, e.g.:
- Nine cases of severe homeopathy-induced liver injuries
- Another death by homeopathy
- HOMEOPATHY – “It is not just irresponsible, it’s downright dangerous.”
- Adverse effects of homeopathy and aggravations at NAFKAM
- Homeopathy: it’s time to stop the double standards
- Homeopathy can cause serious harm – and finally, the NHS England has realised it
- Vidatox, homeopathy’s answer to cancer or outright fraud?
- Another child has died because of homeopathy
- Doctor homeopaths violate fundamental rules of ethics when practising homeopathy
- ‘Best homeopathy doctor in Delhi’ offers treatment for HIV/AIDS
- DIY-Homeopathy: how to kill your entire family
- The risks of homeopathy?
- The FDA has warned 4 manufacturers of unapproved injectable homeopathic drugs
- Is this the crown of the Corona-idiocy? Nosodes In Prevention And Management Of COVID -19
- The FDA has sent more warning letters to homeopathic manufacturers
- Walmart is being sued for selling homeopathic products
- Homoeopathic remedies may be safe, but do all homeopaths merit this attribute?
- Recommending homeoprophylaxis is unethical, irresponsible and possibly even criminal
- FDA: homeopathic teething remedies were toxic
- “Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes.”
- A truly dangerous homeopath
- The scandalous attitude of some homeopaths and their supporters towards immunisations
- Oh yes, let’s have homeopaths as primary care practitioners! But only in a parallel universe,please.
Having warned about the dangers of homeopathy for decades, I feel it is high time for regulators across the world to take appropriate action.
Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non–liver-related systemic side effects. Here is the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center.
A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy.
Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute or chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in ‘supposed’ ultra-dilute formulations.
The authors concluded that homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not ‘gentle placebos.’
The authors also cite our own work on this subject:
A detailed systematic review of homeopathic remedies-induced adverse events from published case reports and case series by Posadzski and colleagues showed that severe side effects, some leading to fatality, are possible with classic and unspecified homeopathic formulations. The total number of patients included was 1159, of which 1142 suffered adverse events directly related to homeopathy. The direct adverse events had acute pancreatitis, severe allergic reactions, arsenical keratosis, bullous pemphigoid, neurocognitive disorders, sudden cardiac arrest and coma, severe dyselectrolytemia, interstitial nephritis, kidney injury, thallium poisoning, syncopal attacks, and focal neurological deficits as well as movement disorders. Fatal events involved advanced renal failure requiring dialysis, toxic polyneuropathy, and quadriparesis. The duration of adverse events ranged from a few hours to 7 months, and 4 patients died. The authors state that in most cases, the mechanism of action for side effects of homeopathy involved allergic reactions or the presence of toxic substances—the use of strong mother tinctures, drug contaminants, adulterants, or poor manufacturing (incorrect dilutions).
When we published our paper back in 2012, it led to a seies of angry responses from defenders of homeopathy who claimed that one cannot ‘have the cake and eat it’; either homeopathic remedies are placebos and thus harmless, or they have effects and thus also side-effects, they claimed. As the new publication by Indian researchers yet again shows, they were mistaken. In fact, homeopathy is dangerous in more than one way:
- the homeopathic remedies can do harm if not diluted or wrongly manufactured;
- the homeopaths can do harm through their often wrong advice in health matters;
- homeopathy erodes rational thinking (as, for instance, the resopnses to our 2012 paper demonstrated).
This study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).
In a single-blind randomized clinical trial, the researchers randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). They evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. Mixed-model ANOVA was used to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.
CFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.
The authors concluded that this study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.
To understand this study, we need to know what CFT and MSI exactly entailed. Here is the information that the authors provide:
Movement system impairment-based treatment
The movement system impairment-based treatment group received 11 sessions of MSI-based treatment over the 8 weeks for 60 min per session with a supervision of a native speaker experienced (above 5 years) physical therapist with the knowledge of MSI-based treatment. The researchers designed the MSI-based treatment uniquely for each patient based on the interview, clinical examination, and questionnaires, just like they did with the CFT intervention. First, they administered standardized tests to characterize changes in the patient’s low back pain symptoms, and then they modified the treatment to make it more specific based on the participant’s individual symptoms. Depending on the participant’s direction-specific low back pain classification, they performed the intervention following one of the five MSI subgroups namely [1] rotation, [2] extension, [3] flexion, [4] rotation with extension, and [5] rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows: [1] education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down; [2] education regarding exercises to perform trunk movements as painlessly as possible; and [3] prescription of functional exercises to improve trunk movement [32].
Cognitive functional therapy
Cognitive functional therapy was prescribed for each patient in CFT group based the CFT protocol conducted by O’Sullivan et al. (2015). Patients received supervised 12 sessions of training over the 8-week period with 60 min per session provided with another physical therapist who had been trained in CFT treatment. In this protocol, a physical therapist with more than 5 years of experience conducted an interview and physical examination of the patients to determine their own unique training programs, considering modifiable cognitive, biopsychosocial, functional, and lifestyle behavior factors. The intervention consists of the following 3 main stages: [1] making sense of pain that is completely reflective, where physical therapist could use the context of the patient’s own story to provide a new understanding of their condition and question their old beliefs [2] exposure with control which is designed to normalize maladaptive or provocative movement and posture related to activities of daily living that is integrated into each patient’s functional impairments, including teaching how to relax trunk muscles, how to have normal body posture while sitting, lying, bending, lifting, moving, and standing, and how to avoid pain behaviors, which aims to break poor postural habits; and [3] lifestyle change which is investigating the influence of unhealthy lifestyles in the patient’s pain context. Assessing the individual’s body mass, nutrition, quality of sleep, levels of physical activity or sedentary lifestyle, smoking, and other factors via video calls. Identifying such lifestyle factors helped us to individually advise and design exercise programs, rebuild self-confidence and self-efficacy, promote changes in lifestyle, and design coping strategies.
I must admit that I am not fully convinced.
Firstly, the study was not large and we need – as the authors state – more evidence. Secondly, I am not sure that the results show CFT to be more effective that MSI. They might merely indicate 1) that the bulk of the improvement is due to non-specific effects (e.g. reression towards the mean, natural history of the condition, placebo) and 2) that CFT is less harmful than MSI.
My conclusion:
we need not just more but better evidence.
A ‘pragmatic, superiority, open-label, randomised controlled trial’ of sleep restriction therapy versus sleep hygiene has just been published in THE LANCET. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563).
Between Aug 29, 2018, and March 23, 2020 the researchers randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19–88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference –3·05, 95% CI –3·83 to –2·28; p<0·0001; Cohen’s d –0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention.
The authors concluded that brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder.
I am frankly amazed that this paper was published in a top journal, like THE LANCET. Let me explain why:
The verum treatment was delivered over four consecutive weeks, involving one brief session per week (two in-person sessions and two sessions over the phone). Session 1 introduced the rationale for sleep restriction therapy alongside a review of sleep diaries, helped participants to select bed and rise times, advised on management of daytime sleepiness (including implications for driving), and discussed barriers to and facilitators of implementation. Session 2, session 3, and session 4 involved reviewing progress, discussion of difficulties with implementation, and titration of the sleep schedule according to a sleep efficiency algorithm.
This means that the verum group received fairly extensive attention, while the control group did not. In other words, a host of non-specific effects are likely to have significantly influenced or even entirely determined the outcome. Despite this rather obvious limitation, the authors fail to discuss any of it. On the contrary, that claim that “we did a definitive test of whether brief sleep restriction therapy delivered in primary care is clinically effective and cost-effective.” This is, in my view, highly misleading and unworthy of THE LANCET. I suggest the conclusions of this trial should be re-formulated as follows:
The brief nurse-delivered sleep restriction, or the additional attention provided exclusively to the patients in the verum group, or a placebo-effect or some other non-specific effect reduced insomnia symptoms.
Alternatively, one could just conclude from this study that poor science can make it even into the best medical journals – a problem only too well known in the realm of so-called alternative medicine (SCAM).
I have to admit that I do not regularly read the DMZ, a German paper. In fact, until a minute ago, I did not know it existed. Nor do I know Anton Aeberhard. I saw his DMZ homeopathy article on the Internet and find it excellent; so much so that I translated parts of it for you:
… Because this pseudoscience is considered by some people to be an effective alternative to conventional medicine, it is important to understand the potential dangers and risks of homeopathy…
Homeopathy is based on the principle of the rule of similars and extreme dilution of substances. However, there is no scientific evidence that homeopathic remedies have any therapeutic effect beyond the placebo effect. Most studies that purport to show efficacy are methodologically flawed. Homeopathy contradicts fundamental principles of biology, chemistry, and physics. It is therefore irresponsible to consider this practice a legitimate medical treatment.
One of the greatest and real dangers of homeopathy is that it can cause people to refuse or delay effective medical treatments. By believing in homeopathic remedies, life-threatening conditions such as cancer, heart disease, or infections may not be treated appropriately. This can lead to worsening health conditions and increase the risk of complications or even death…
Conclusion I
Homeopathy is a pseudoscientific practice based on outdated principles and a lack of scientific evidence. The dangers of this practice should not be underestimated. It can cause people to reject or delay effective medical treatments, which can endanger their health and lives. It is important to make informed decisions about health care and to rely on evidence-based medicine to provide the best possible treatment and care.
Conclusion II.
Homeopathy is a joke.
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Thank you Anton Aeberhard!
It is not often that we find a journalist who has the courage to defy the demand for ‘balance’. In the case of clear nonsensical issues, this demand becomes a demand for misleading people, a demand for FALSE balance!
When a journalist writes about the planet, he does not require a representative of the FLAT EARTH SOCIETY to add his views. Similarly, when someone writes about homeopathy, there is no need to interview the chair of a homeopaths’ association saying: “But we have 200 years of experience and we therefore know it works…”
