progress
Open-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving an inert sugar pill with no activity of its own. Intuitively, we think that such treatments must be ineffective. Yet, there have been several studies that seemed to show otherwise.
The objective of this paper was to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and 13 studies were included in the systematic review. Eleven trials were eligible for meta-analysis.
These trials assessed the effects of OLPs on
- back pain,
- cancer-related fatigue,
- attention deficit hyperactivity disorder,
- allergic rhinitis,
- major depression,
- irritable bowel syndrome,
- menopausal hot flushes.
The risk of bias was moderate among all studies.
Click to enlarge.
A significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions. Yet, the researchers spotted several caveats and discuss them in some detail.
First, we detected hints of a publication bias in the study sample, but the respective test was not significant. The quantitative basis of the meta-analysis is based on a small number of studies, reflecting the early state of research in this field. Moreover, the set of studies showed some heterogeneity. Finally, four studies were rated to have a high risk of bias, and nine to have some concerns.
In order to assess the impact of these high-risk studies we performed an exploratory best-evidence synthesis. We excluded the four studies with a high risk of bias. In this analysis, the heterogeneity could be reduced to a non-critical value and almost all variance in the set of studies could be explained by a sampling error (I2 = 4%). With the exclusion of these four studies the mean effect size was reduced to a more conservative SMD = 0.49.
Regardless of this reduction of the overall effect, the same conclusions about the treatment-effect of OLPs can be drawn, although the lack of robustness means that interpretations require some caution. The decrease of heterogeneity shows that methodological impairments might be responsible for the considerable unexplained variance in our results. We abstained from carrying out a further sensitivity analysis for explaining heterogeneity because of the small number of studies.
This is certainly an interesting subject. And the above findings are certainly counter-intuitive.
My impression is that the effect of OLPs is small and of doubtful value in clinical practice. My prediction is that, as more and better research emerges, it will diminish further, if not vanish totally. I think that there are several reasons for this:
- The number of trials is still quite small.
- The studies obviously lack patient blinding.
- Positive messages can be included alongside open-label placebos.
- The “time lag bias” is high.
This type of bias means that, due to initial enthusiasm in a new subject, negative results are published with some delay. I have observed this bias repeatedly in the past. A new treatment initially tends to generate nothing but positive results, and only after a while, when the researchers’ euphoria has subsided, more realistic findings emerge.
Conspiracy beliefs are associated with detrimental health attitudes during the coronavirus pandemic. Prior research on these issues was mostly cross-sectional, however, and restricted to attitudes or behavioral intentions. This investigation was designed to examine to what extent conspiracy beliefs predict health behavior and well-being over a longer period of time.
In this multi-wave study on a large (N = 5745) Dutch research panel (weighted to provide nationally representative population estimates), the researchers examined if conspiracy beliefs early in the pandemic (April 2020) would predict a range of concrete health and well-being outcomes eight months later (December 2020).
The results revealed that Covid-19 conspiracy beliefs prospectively predicted a decreased likelihood of getting tested for corona; if tested, an increased likelihood of the test coming out positive; and, an increased likelihood of having violated corona regulations, deteriorated economic outcomes (job loss; reduced income), experiences of social rejection, and decreased overall well-being. Most of these effects generalized to a broader susceptibility to conspiracy theories (i.e. conspiracy mentality).
The authors concluded that conspiracy beliefs are associated with a myriad of negative life outcomes in the long run. Conspiracy beliefs predict how well people have coped with the pandemic over a period of eight months, as reflected in their health behavior, and their economic and social well-being.
These findings tie in with another recent study that investigated whether individual beliefs and personal characteristics differences affect people’s likelihood of contracting COVID-19. In the early months of the pandemic, U.S. participants responded to a variety of individual difference measures as well as questions specific to the pandemic itself. Four months later, 2120 of these participants were asked whether they had contracted COVID-19. Nearly all of the included individual difference measures significantly predicted whether a person reported testing positive for the virus in this four-month period. Additional analyses revealed that all of these relationships were primarily mediated by whether participants held accurate knowledge about COVID-19.
I find it hard not to despair vis a vis such results. Not that they were not to be expected – if you ignore the existence of risk factors exist for heart attacks, it seems plausible that your likelihood of dying of myocardial infarction is increased. What is particularly desolating are two facts:
- This pandemic seems to have rendered the voices of stupidity and ignorance loud and popular, even fashionable.
- Those lunatics who adhere to conspiracy beliefs harm not merely themselves but endanger all of us.
I ask myself how we will ever get past this new age of unreason.
This review summarized the available evidence on so-called alternative medicine (SCAM) used with radiotherapy. Systematic literature searches identified studies on the use of SCAM during radiotherapy. Inclusion required the following criteria: the study was interventional, SCAM was for human patients with cancer, and SCAM was administered concurrently with radiotherapy. Data points of interest were collected from included studies. A subset was identified as high-quality using the Jadad scale. Fisher’s exact test was used to assess the association between study results, outcome measured, and type of SCAM.
Overall, 163 articles met inclusion. Of these, 68 (41.7%) were considered high-quality trials. Articles published per year increased over time. Frequently identified therapies were biologically based therapies (47.9%), mind-body therapies (23.3%), and alternative medical systems (13.5%). Within the subset of high-quality trials, 60.0% of studies reported a favorable change with SCAM while 40.0% reported no change. No studies reported an unfavorable change. Commonly assessed outcome types were patient-reported (41.1%) and provider-reported (21.5%). The rate of favorable change did not differ based on the type of SCAM or outcome measured.
The authors concluded that concurrent SCAM may reduce radiotherapy-induced toxicities and improve quality of life, suggesting that physicians should discuss SCAM with patients receiving radiotherapy. This review provides a broad overview of investigations on SCAM use during radiotherapy and can inform how radiation oncologists advise their patients about SCAM.
In my recent book, I have reviewed the somewhat broader issue of SCAM for palliative and supportive care. My conclusions are broadly in agreement with the above review:
… some forms of SCAM—by no means all— benefit cancer patients in multiple ways… four important points:
• The volume of the evidence for SCAM in palliative and supportive cancer care is currently by no means large.
• The primary studies are often methodologically weak and their findings are contradictory.
• Several forms of SCAM have the potential to be useful in palliative and supportive cancer care.
• Therefore, generalisations are problematic, and it is wise to go by the current best evidence …
One particular finding of the new review struck me as intriguing: The rate of favorable change did not differ based on the type of SCAM. Combined with the fact that most studies are less than rigorous and fail to control for non-specific effects, this indicates to me that, in cancer palliation (and perhaps in other areas as well), SCAM works mostly via non-specific effects. In other words, patients feel better not because the treatment per se was effective but because they needed the extra care, attention, and empathy.
If this is true, it carries an important reminder for oncology: cancer patients are very vulnerable and need all the empathy and compassion they can get. Seen from this perspective, the popularity of SCAM would be a criticism of conventional medicine for not providing enough of it.
The complex links between so-called alternative medicine (SCAM) and the pandemic have been a regular subject on this blog. Here is more:
This study investigated if people’s response to the official recommendations during the COVID-19 pandemic is associated with conspiracy beliefs related to COVID-19, a distrust in the sources providing information on COVID-19, and an endorsement of SCAM.
The sample consisted of 1325 Finnish adults who filled out an online survey advertised on Facebook. Structural regression analysis was used to investigate whether:
1) conspiracy beliefs, a distrust in information sources, and endorsement of SCAM predict people’s response to the non-pharmaceutical interventions (NPIs) implemented by the government during the COVID-19 pandemic,
2) conspiracy beliefs, a distrust in information sources, and endorsement of CAM are related to people’s willingness to take a COVID-19 vaccine.
The results indicate that individuals with more conspiracy beliefs and lower trust in information sources were less likely to have a positive response to the NPIs. Individuals with less trust in information sources and more endorsement of SCAM were more unwilling to take a COVID-19 vaccine. Distrust in information sources was the strongest and most consistent predictor in all models. In addition, the analyses revealed that some of the people who respond negatively to the NPIs also have a lower likelihood to take the vaccine. This association was partly related to lower trust in information sources.
The authors concluded that distrusting the establishment to provide accurate information, believing in conspiracy theories, and endorsing treatments and substances that are not part of conventional medicine, are all associated with a more negative response to the official guidelines during COVID-19. How people respond to the guidelines, however, is more strongly and consistently related to the degree of trust they feel in the information sources than to their tendency to hold conspiracy beliefs or endorse CAM. These findings highlight the need for governments and health authorities to create communication strategies that build public trust.
I also believe that these findings highlight the urgent need for improvements in education. In my view, it should start at school and continue into adult life. It should focus on a better understanding of science and – crucially – on the ability to differentiate facts from fiction and conspiracies.
Thanks to Richard Rasker, a regular commentator on this blog, I learnt a new word – a word that I intend to use regularly from now on:
proctophasia
You won’t find the term in the dictionary, and even the most decorated specialist might not (yet?) be familiar with it. Proktophasia afflicts predominantly the most ardent evangelists amongst the proponents of so-called alternative medicine (SCAM), COVID-deniers, and anti-vaxxers. And this is, of course, the reason why the affliction surfaces regularly on this blog, and why Richard was able to recognize it and give it its proper terminology.
The symptoms of proctophasia are easily remembered, once we know that this medical term is derived from ‘speaking out of one’s arse’, a less than polite term for talking utter rubbish. Accordingly, proctophasia shows itself in the following manner:
- talking rubbish,
- talking rubbish,
- talking rubbish,
- talking rubbish,
- talking rubbish,
- talking rubbish,
- talking rubbish,
- talking rubbish,
- talking rubbish even after being corrected,
- repeating one’s own stupid arguments ad nauseam,
- repeating one’s own stupid arguments ad nauseam,
- repeating one’s own stupid arguments ad nauseam,
- repeating one’s own stupid arguments ad nauseam,
- repeating one’s own stupid arguments ad nauseam,
- being offended when, eventually, someone arrives at the correct diagnosis of ‘speaking out of one’s arse’,
- being nevertheless undeterred and repeating one’s own stupid arguments ad nauseam.
As such, the diagnosis is not all that difficult to make. The crucial question, however, is this:
can proctophasia be treated successfully?
It does seem unlikely that any form of SCAM is effective in the management of proctophasia. Formal trials have, as far as I know, not been conducted. Yet, we can assume from the fact that the proctophasia victims who made themselves known in the comments sections of this blog are on multiple SCAM treatments, and their condition does not seem to improve noticeably. On the contrary, one could even speculate that SCAM is the cause of the disease (but, of course, this hypothesis would need to be tested before we should accept it as fact).
Until there is a cure, what can be done?
I am afraid not much. In the past, I have had to ban some particularly seriously afflicted individuals. No doubt, I will have to take such drastic measures again in the future. But I always do that with a heavy heart.
Why?
Because one feature of the typical proctophasia victim has not yet been mentioned. These people can be hilariously funny – more so than any stand-up comedian. And that is the reason why I will continue to be as patient with them as I possibly can. In other words, proctophasia significantly increases the entertainment value of this blog.
Thanks, guys!
In a recently published study, the willingness to be vaccinated of parents of underage children and persons without underage children was examined. The study was based on a random sample (telephone survey, n = 2014, survey between 12.11.2020 and 10.12.2020).
The results revealed that parents consistently show a lower propensity to vaccinate with a COVID-19 vaccine than respondents without minor children (54.1% vs. 71.1%). Fathers showed a more pronounced own willingness to vaccinate than mothers. Furthermore, men were more willing than women to have their own child vaccinated with a COVID-19 vaccine.
The overall sample also showed that a rejection of so-called alternative medicine (SCAM) was associated with a significantly higher willingness to be vaccinated. There was also a significant correlation between the attitude towards homeopathy and one’s own willingness to be vaccinated. If homeopathy was supported, the willingness to vaccinate was lower. This correlation between the attitude towards homeopathy and willingness to vaccinate was also evident in the sub-sample of parents. Among the parents, it was again the women who significantly more often had a positive attitude towards homeopathy than men, who more often do not think anything of it.
This new evidence ties in neatly with many of my previous posts on the subject of SCAM and vaccination, for instance:
- More information on homeopaths’ and anthroposophic doctors’ attitude towards vaccinations
- The anti-vaccination movement is financed by the dietary supplement industry
- The UK Society of Homeopaths, a hub of anti-vaccination activists?
- HOMEOPATHY = “the complete alternative to vaccination” ?!?!
- Are anthroposophy-enthusiasts for or against vaccinations?
- Far too many chiropractors believe that vaccinations do not have a positive effect on public health
- Andrew Wakefield, Donald Trump, SCAM, and the anti-vaccination cult
- Naturopaths’ counselling against vaccinations could be criminally negligent
- HOMEOPATHS AGAINST VACCINATION: “The decision to vaccinate and how you implement that decision is yours and yours alone”
- Use of alternative medicine is associated with low vaccination rates
- Integrative medicine physicians tend to harbour anti-vaccination views
- Vaccination: chiropractors “espouse views which aren’t evidence based”
- Faith-healing as an alternative to vaccination?
- Learning about homeopathy the hard way: the story of Aaron Rodgers
- Patients consulting chiropractors, homeopaths, or naturopaths are less likely to agree to the flu jab
- Parents’ Willingness to Vaccinate with a COVID-19 Vaccine: strongly influenced by homeopathy
- “The uncensored truth” about COVID-19 vaccines” … as told by some chiro loons
- Beliefs and behaviors of US chiropractors
- Many naturopaths, homeopaths, and chiropractors are a risk to public health
- Homeopaths (and other SCAM practitioners) are peddling dangerous myths
- Misinformation and fraudulent claims about boosting immunity during the pandemic
Collectively, this evidence tells us that:
- the effect has been shown in many different ways,
- it can therefore be assumed to be real,
- it is not confined to COVID vaccinations,
- it is not confined to one particular branch of SCAM,
- it even affects MDs (who surely should know better) dabbling in SCAM,
- it has a long history,
- it is prevalent in many, if not most countries,
- it does real harm.
So, the next time someone tells you that SCAM and SCAM practitioners have a positive influence on public health, tell them to think again.
The British Royal Family have been proponents of homeopathy for generations. Homeopathy was originally introduced into the UK by Frederic Hervey Foster Quin who, as a young physician, had visited Hahnemann in Koethen, Germany. Quin was soon fully converted to homeopathy and returned to England. Being well-connected to the European aristocracy, he managed to attract many influential personalities to homeopathy. In 1844, he founded the British Homeopathic Society and, in 1850, he opened the predecessor of the Royal London Homeopathic Hospital which is today called the Royal London Hospital for Integrated Medicine.
Our Queen has many times been reported to swear by her homeopathic remedies. Some went as far as claiming her good health in old age must be due to her using homeopathy to keep well. Here is just one example from ‘THE OFFICIAL HOMEOPATHY RESOURCE’ of 2016:
On her 90th birthday, the London Weekly News reports that in spite of criticism the Queen has used homeopathy all her life and has remarkable good health. In fact, many generations of the Royal family have used homeopathy
For as The Queen marks her 90th birthday on April 21, that she has reached such an excellent age is largely due to her lifelong trust in homeopathy. Everywhere that Her Majesty goes she is accompanied by a small case of special cures and tinctures and, although doctors no not care to admit it, it is because of her herbal little helpers that she rarely gets a cold or any other sort of complaint.
Empiricists would argue that as both The Queen and the late Queen Mother have been avid fans of homeopathy and as The Queen Mum died at the age of 101, the glaring probability that it works seems to be rather evident.
Sadly, her good health cannot last forever, and we have all seen recent reports of her being unwell, spending one night in hospital, and announcing the cancellation of all her engagements during the next two weeks resting on doctors’ orders.
Which doctors?
Peter Fisher was her homeopath, but he tragically died three years ago. Did the Queen appoint another homeopath to look after her? Did she go into the Royal London Hospital for Integrated Medicine when she was ill? Was she reported to be taking homeopathic remedies during her recovery? The answer to all those questions seems to be NO.
What does that tell us?
I have often observed that our Royals use homeopathy while they are well and conventional medicine when they are ill. The Queen might have followed this strategy too. But not appointing a successor to Peter Fisher suggests something quite different. Does it indicate, I ask myself, that the Queen has recently had the occasion to look at the evidence and concluded – as most intelligent people did some time ago – that homeopathy does not work beyond placebo?
I certainly hope so, not least because refusing to rely on homeopathy would significantly increase her chances of remaining our Queen for some time to come.
The Austrian Health Insurance Fund is the largest social health insurance in Austria. Currently, about 82 percent of the people living in our country are insured with the ÖGK – that is 7.2 million insured persons. The ÖGK was created on 01.01.2020 through the merger of the nine former regional health insurance funds.
I was alerted to the following announcement by the Austrian Health Insurance Fund (my translation):
The Austrian Health Insurance Fund (ÖGK) ensures comprehensive medical care. However, medical services that do not treat an illness or contribute to preventive health care have to be paid for by the insured persons themselves
In the following cases, you have to pay for the services yourself, even if you use a panel doctor (Vertrauensarzt):
- Sports or driving licence examinations
- Exemptions from gym classes
- Vaccinations (if they are not medical treatment)
- Second medical opinions
- Requests for nursing leave
- Employment examinations on commencement of employment
- Treatments for which there is no scientific medical evidence of effectiveness (e.g. homeopathy)
- Purely cosmetic treatments
- Examinations for the clarification of claims for disability, occupational incapacity, incapacity to work.
The term HOMEOPATHY was not highlighted in the original. As it is, however, of particular interest to the discussions on this blog, I took the liberty of doing so.
The writing for homeopathy had been on the wall for some time in Austria- to be exact, since 1819!
This is when his majesty, the emperor Franz 2nd, issued the above decree strictly forbidding Hahnemann’s method.
My translation:
Prohibition of Hahnemann’s healing method
His Majesty, by the highest resolution of October 13, 1819, decreed: Doctor Hahnemann’s homeopathic method of treatment is to be generally and strictly prohibited.
Court Chancellery Decree of 21 October 1819, to all State Offices
In so-called alternative medicine (SCAM), vitamin D is often recommended for a range of indications, including cancer prevention. Observational studies did indeed suggest that low vitamin D status may be a risk factor for cancer. On the basis of such evidence, a team of researchers sought to determine if vitamin D supplementation lowers the risk of cancer and precancers.
The Vitamin D and type 2 diabetes (D2d) cancer outcomes study (D2dCA) is an ancillary study to the D2d study, which was conducted at 22 academic medical centers in the United States. Participants had prediabetes and overweight/obesity and were free of cancer for the previous 5 years. Participants were randomized to receive vitamin D3 4000 IU daily or placebo. At scheduled study visits (4 times/year), cancer and precancer events were identified by questionnaires. Clinical data were collected and adjudicated for all reported events. Cox proportional hazard models compared the hazard ratio (HR) of incident cancers and precancers between groups.
Over a median follow-up period of 2.9 years, among 2385 participants (mean age 60 years and 25-hydroxyvitamin D 28 ng/mL), there were 89 cases of cancer. The hazard ratio (HR) of incident cancer for vitamin D vs placebo was 1.07 (95% CI 0.70, 1.62). Of 241 participants with incident precancers, 239 had colorectal adenomatous polyps. The HR for colorectal polyps for vitamin D vs placebo was 0.83 (95% CI 0.64, 1.07).
The authors concluded that, in the D2d population of participants with prediabetes and overweight/obesity, not selected for vitamin D insufficiency, vitamin D supplementation did not have a significant effect on risk of incident cancer or colorectal polyps.
For some reason, the discussions about the value of vitamin D for any condition tend to be dominated by emotion rather than evidence. This is particularly true in the realm of SCAM. The trial is a significant step forward. It is rigorous and generates clear findings. Let’s hope it will contribute to a more rational debate about the value of vitamin D in cancer prevention.
The bad news for German homeopathy just keeps on coming. As I reported, recent events must be depressing for homeopaths, e.g.:
- A recent investigation disclosed that the German homeopathy cult is at the heart of Germany’s anti-vax movement.
- In July 2021, a German court ruled against a homeopathic HCG remedy.
- In 2020, a German study failed to show that homeopathy is cost-effective.
- In 2019, the attempt by a German homeopathy manufacturer to silence critics backfired spectacularly.
- About 10 years ago, 5 German firms clubbed together supporting a journalist at the tune of Euro 30 000/year to defame me (at the time I was one of the few who regularly informed the public about the evidence on homeopathy). The plot was discovered and published whereupon the journalist committed suicide.
After heated debates in the run-up, the Bavarian Medical Association decided yesterday to ditch the postgraduate education program in homeopathy for its doctors. This means that, of the 17 regional medical associations in Germany, 12 have now discontinued their further education efforts in homeopathy. The ones that have not yet done so are:
- Baden-Württemberg,
- Rhineland-Palatinate,
- Saxony,
- Thuringia,
- Westphalia-Lippe.
In the past months, homeopaths had collected 11,597 signatures in favor of maintaining the additional qualification of homeopathy. The ~ 400 doctors in Bavaria, who have acquired ‘homeopathy’ as an additional title, will be permitted to continue to use it.
The spokesperson of the Information Network Homeopathy, Dr. Christian Lübbers, welcomed the decision of the Medical Association. It was a “landslide victory for patient safety”, he said. The Bavarian regional chairman of the German Central Association of Homeopathic Doctors, Dr. Ulf Riker, regretted the outcome of the vote and added: “We will consider legal steps very seriously.” I would advise against such a step which would only render homeopaths more ridiculous than they already are.
Yes, it’s bad news for German homeopaths – very bad news indeed. Of course, homeopathy fans will claim that it is all a sinister conspiracy against them. Sadly, they are unable to realize that the only driving force behind the long-overdue decline of German homeopathy is the evidence: HOMEOPATHY DOES NOT WORK BEYOND PLACEBO and therefore it has no place in the evidence-based medicine of the 21st century.
