Prof Harald Walach has had a few rough weeks. First, he published his paper suggesting that Covid vaccinations do more harm than good which was subsequently retracted as flawed, if not fraudulent. Next, he published a paper showing that children are put in danger when wearing face masks suggesting that “decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.” Now, the journal put out the following announcement about it:
The Research Letter, “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children: A Randomized Clinical Trial,” by Harald Walach, PhD, and colleagues published online in JAMA Pediatrics on June 30, 2021,1 is hereby retracted.
Following publication, numerous scientific issues were raised regarding the study methodology, including concerns about the applicability of the device used for assessment of carbon dioxide levels in this study setting, and whether the measurements obtained accurately represented carbon dioxide content in inhaled air, as well as issues related to the validity of the study conclusions. In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review. Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter.
To make things even worse, Walach’s University fired him because of his fraudulent anti-vax research. Poznan University of Medical Sciences tweeted on 6 July:
We wish to emphasize that the claims included in dr Harald Walach’s recent article in @Vaccines_MDPI do not represent the position of @PUMS_tweets . We find that the article lacked scientific diligence and proper methodology. Dr. Walach’s affiliation with PUMS was now terminated. Throughout the pandemic PUMS has actively promoted vaccination programs, offering scientific expertise in the media, broadcasting seminars, and reported on progress of the vaccination program. We consider vaccinations as the paramount tool in the global fight against the pandemic. We consider vaccinations as the paramount tool in the global fight against the #pandemic. Over 85% of our own academic community has already been vaccinated with support and encouragement from the University.
As I said, this is truly unlucky …
.. or perhaps not?
Come to think of it, it is lucky when pseudo-science and fraud are called out. It means that the self-cleaning mechanisms of science are working and we are protected from the harm done by charlatans.
Mind-body interventions (MBIs) are one of the top ten so-called alternative medicine (SCAM) approaches utilized in pediatrics, but there is limited knowledge on associated adverse events (AE). The objective of this review was to systematically review AEs reported in association with MBIs in children.
Electronic databases MEDLINE, Embase, CINAHL, CDSR, and CCRCT were searched from inception to August 2018. The authors included primary studies on participants ≤ 21 years of age that used an MBI. Experimental studies were assessed for whether AEs were reported on or not, and all other study designs were included only if they reported an AE.
A total of 441 were included as primary pediatric MBI studies. Of these, 377 (85.5%) did not explicitly report the presence/absence of AEs or a safety assessment. In total, there were 64 included studies: 43 experimental studies reported that no AE occurred, and 21 studies reported AEs. A total of 37 AEs were found, of which the most serious were grade 3. Most of the studies reporting AEs did not report on severity (81.0%) or duration of AEs (52.4%).
The authors concluded that MBIs are popularly used in children; however associated harms are often not reported and lack important information for meaningful assessment.
SCAM is far too often considered to be risk-free. This phenomenon is particularly stark if the SCAM in question does not involve physical or pharmacological treatments. Thus MBIs are seen and often waved through as especially safe. Consequently, many researchers do not even bother to monitor AEs in their clinical trials. This might be understandable, but it is nevertheless a violation of research ethics.
This new review is important in that it highlights these issues. It is high time that we stop giving researchers in SCAM the benefit of the doubt. They may or may not make honest mistakes when not reporting AEs. In any case, it is clear that they are not properly trained and supervised. All too often, we still see clinical trials run by amateurs who have little idea of methodology and even less of ethics. The harm this phenomenon does is difficult to quantify, but I fear it is huge.
The usage of so-called alternative medicine (SCAM) in pediatric settings has been high for some time. However, the risks of pediatric SCAM use remain under-investigated. Almost 20 years ago, I published this systematic review:
Unconventional therapies have become popular in paediatric and adolescent populations. It is therefore important to define their risks. The aim of this systematic review was to summarise the recent evidence. Computerised literature searches were carried out in five databases to identify all recent reports of adverse events associated with unconventional therapies in children. The reports were summarised in narrative and tabular form. The results show that numerous case reports and several case series have been published since 1990. Investigations of a more systematic nature are, however, rare. Most of the adverse events were associated with herbal medications. Inadequately regulated herbal medicines may contain toxic plant material, be contaminated with heavy metals, or be adulterated with synthetic drugs. The adverse events included bradycardia, brain damage, cardiogenic shock, diabetic coma, encephalopathy, heart rupture, intravascular haemolysis, liver failure, respiratory failure, toxic hepatitis and death. A high degree of uncertainty regarding a causal relationship between therapy and adverse event was frequently noted. The size of the problem and its importance relative to the well-documented risks of conventional treatments are presently unknown. Several unconventional therapies may constitute a risk to the health of children and adolescents. At present, it is impossible to provide reliable incidence figures. It seems important to be vigilant and investigate this area more systematically.
Nothing much has happened since in terms of systematic investigation. But now, a 3-year survey was carried out at the Dutch Pediatric Surveillance Unit. Pediatricians were asked to register cases of adverse events associated with pediatric SCAM usage.
In 3 years, 32 unique adverse events were registered. Twenty-two of these adverse events were indirect and not related to the specific SCAM therapy but due to delaying, changing, or stopping of regular treatment, a deficient or very restrictive diet, or an incorrect diagnosis by a SCAM therapist. These events were associated with many different SCAM therapies.
Nine events were deemed direct adverse events like bodily harm or toxicity and one-third of them occurred in infants. Only supplements, manual therapies, and (Chinese) herbs were involved in these nine events. In one case, there was a risk of a serious adverse event but the harm had not yet occurred.
The authors concluded that relatively few cases of adverse events associated with pediatric SCAM usage were found, mostly due to delaying or stopping conventional treatment. Nevertheless, parents, pediatricians, and SCAM providers should be vigilant for both direct and indirect adverse events in children using SCAM, especially in infants.
The number of cases seems small indeed, but there may be many further adverse events that went unreported. Here are 4 of the documented cases of severe and life-threatening consequences:
- An 8-year-old child with autoimmune hypothyroidism had his prescribed replaced with an ineffective herbal remedy.
- A 14-year-old child developed septic shock with multiple organ failure after receiving homeopathy for acute appendicitis.
- A 14-year-old child needed colectomy after ineffective naturopathic treatments for colitis.
- A 5-year-old developed secondary adrenal insufficiency after his eczema was treated with Chinese herbal remedies adulterated with large doses of corticosteroids.
In view of the risks – even if small – I suggest that, in pediatric settings, we employ only those SCAMs that are supported by solid evidence. And those are very few indeed.
The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.
The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.
Here are 6 results that I found noteworthy:
- Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
- Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
- Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
- Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
- Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
- Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.
Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:
- Do you believe in the concept of subluxation?
- Do you treat conditions other than spinal problems?
- How frequently do you use spinal manipulations?
- How often do you see adverse effects of spinal manipulation?
- Do you obtain informed consent from all patients?
- How often do you refer patients to medical doctors?
- Do you advise in favour of vaccinations?
- Do you follow the rules of evidence-based medicine?
- Do you offer advice about prescribed medications?
- Which supplements do you recommend?
- Do you recommend maintenance treatment?
I wonder why they were not included.
Osteopathic manipulative treatment (OMT) is frequently recommended by osteopaths for improving breastfeeding. But does it work?
This double-blind randomised clinical trial tested whether OMT was effective for facilitating breastfeeding. Breastfed term infants were eligible if one of the following criteria was met:
- suboptimal breastfeeding behaviour,
- maternal cracked nipples,
- maternal pain.
The infants were randomly assigned to the intervention or the control group. The intervention consisted of two sessions of early OMT, while in the control group, the manipulations were performed on a doll behind a screen. The primary outcome was the exclusive breastfeeding rate at 1 month, which was assessed in an intention-to-treat analysis. Randomisation was computer generated and only accessible to the osteopath practitioner. The parents, research assistants and paediatricians were masked to group assignment.
One hundred twenty-eight mother-infant dyads were randomised, with 64 assigned to each group. In each group, five infants were lost to follow-up. In the intervention group, 31 of 59 (53%) of infants were still exclusively breastfed at 1 month vs 39 of 59 (66%) in the control group. After adjustment for suboptimal breastfeeding behaviour, caesarean section, use of supplements and breast shields, the adjusted OR was 0.44. No adverse effects were reported in either group.
The authors concluded dryly that OMT did not improve exclusive breastfeeding at 1 month.
This is a rigorous trial with clear and expected results. It was conducted in cooperation with a group of 7 French osteopaths, and the study was sponsored by the ‘Société Européenne de Recherche en Osthéopathie Périnatale et Pédiatrique’, the ‘Fonds pour la Recherche en Ostéopathie’ and ‘Formation et Recherche Ostéopathie et Prévention’. The researchers need to be congratulated on publishing this trial and expressing the results so clearly despite the fact that the findings were not what the osteopaths had hoped for.
Three questions come to my mind:
- Is any of the many therapeutic recommendations of osteopaths valid?
- Why was it ever assumed that OMT would be effective?
- Do we really have to test every weird assumption before we can dismiss it?
Tuina is a massage therapy that originates from Traditional Chinese Medicine. Many of the techniques used in tuina resemble those of a western massage like gliding, kneading, vibration, tapping, friction, pulling, rolling, pressing, and shaking. Tuina involves a range of manipulations usually performed by the therapist’s finger, hand, elbow, knee, or foot. They are applied to muscle or soft tissue at specific locations of the body.
The aim of Tuina is to enhance the flow of the ‘vital energy’ or ‘chi’, that is alleged to control our health. Proponents of the therapy recommend Tuina for a range of conditions, including paediatric ones. Paediatric Tuina has been widely used in children with acute diarrhea in China. However, due to a lack of high-quality clinical evidence, the benefit of Tuina is not clear.
This study aimed to assess the effect of paediatric Tuina compared with sham Tuina as add-on therapy in addition to usual care for 0-6-year-old children with acute diarrhea.
Eighty-six participants aged 0-6 years with acute diarrhea were randomized to receive Tuina plus usual care (n = 43) or sham Tuina plus usual care (n = 43). The primary outcomes were days of diarrhea from baseline and times of diarrhea on day 3. Secondary outcomes included a global change rating (GCR) and the number of days when the stool characteristics returned to normal. Adverse events were assessed.
Tuina treatment in the intervention group was performed on the surface of the children’s body using moderate pressure (Fig. 1a). Tuina treatment in the control group was different: the therapist used one hand to hold the child’s hand or put one hand on the child’s body, while the other hand performed manipulations on the therapist’s own hand instead of the child’s hand or body (Fig. (Fig.11b).
Tuina was associated with a reduction in times of diarrhea on day 3 compared with sham Tuina in both ITT and per-protocol analyses. However, the results were not significant when adjusted for social-demographic and clinical characteristics. No significant difference was found between groups in days of diarrhea, global change rating, or number of days when the stool characteristics returned to normal.
The authors concluded that in children aged 0-6 years with acute diarrhea, pediatric Tuina showed significant effects in terms of reducing times of diarrhea compared with sham Tuina. Studies with larger sample sizes and adjusted trial designs are warranted to further evaluate the effect of pediatric Tuina therapy.
This study was well-reported and has interesting features, such as the attempt to use a placebo control and blinding (whether blinding was successful is a different matter and was not tested in the trial). It is, therefore, all the more surprising that the essentially negative result is turned into a positive one. After adjustment, the differences disappear (a fact which the authors hardly mention in the paper), which means they are not due to the treatment but to group differences and confounding. This, in turn, means that the study shows not the effectiveness but the ineffectiveness of Tuina.
Many homeopaths will tell you that they like to treat children because they respond particularly well to their remedies. This notion is widely promoted and often is the reason why mothers take their kid to homeopath. Some parents even take it for established wisdom. Yet there is a major problem with it:
IT IS NOT TRUE!
A systematic review and meta-analysis investigated the benefits and risks for oral homeopathic remedies used to treat and prevent acute respiratory tract infections (ARTIs) in children. Extensive literature searches were used to identify all double-blinded randomized trials in children, treated with oral homeopathic remedies versus placebo or conventional treatments for ARTI. Studies were reviewed in duplicate for inclusion, data extraction and risk of bias. Meta-analysis was performed on only 4 outcomes. Other outcomes were reported narratively.
Eight studies (1562 children) were included. Four studies examined treatment and 4 prevention of ARTIs. Four studies involved homeopaths individualizing treatment versus four with non-individualized treatments. Three studies had high risk of bias in at least one domain. All studies with low risk of bias showed no benefit from homeopathy; trials at uncertain and high risk of bias reported beneficial effects. Two individualized treatment studies (N=155) did not show benefit on short-term or long-term cure. Prevention trials showed no significant outcomes: recurrence of ARTIs. No serious adverse events were reported.
The authors concluded that the effectiveness for homeopathic remedies for childhood ARTIs is not supported in higher quality trials.
This paper is the up-date of the current Cochrane review which concluded that pooling of two prevention and two treatment studies did not show any benefit of homeopathic medicinal products compared to placebo on recurrence of ARTI or cure rates in children. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, so conclusions about safety could not be drawn.
And to prevent errors about conditions other than ARTIs, let me remind you of our systematic review of homeopathy for ANY childhood disease. It concluded that the evidence from rigorous clinical trials of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition.
So, next time you hear a homeopath claim that his/her treatments are especially good for kids, be warned: the claim merely supports his/her income but not your child.
Steiner with his wife (right) and Ita Wegman, his lover (left).
Anthroposophic medicine was founded by Steiner and Ita Wegman in the early 20th century. Currently, it is being promoted as an extension of conventional medicine. Proponents claim that “its unique understanding of the interplay among physiological, soul and spiritual processes in healing and illness serves to bridge allopathy with naturopathy, homeopathy, functional/nutritional medicine and other healing systems.” Its value has repeatedly been questioned, and clinical research in this area is often less than rigorous.
Anthroposophic education was developed in the Waldorf school that was founded by Steiner in 1919 to serve the children of employees of the Waldorf-Astoria cigarette factory in Stuttgart, Germany. Pupils of Waldorf or Steiner schools, as they are also frequently called, are encouraged to develop independent thinking and creativity, social responsibility, respect, and compassion.
Waldorf schools implicitly infuse spiritual and mystic concepts into their curriculum. Like some other alternative healthcare practitioners – for instance, doctors promoting integrative medicine, chiropractors, homeopaths and naturopaths – some doctors of anthroposophic medicine take a stance against childhood immunizations. In a 2011 paper, I summarised the evidence which showed that in the UK, the Netherlands, Austria and Germany, Waldorf schools have been at the centre of measles outbreaks due to their stance regarding immunisations.
More recently, a study evaluated trends in rates of personal belief exemptions (PBEs) to immunization requirements for private kindergartens in California that practice alternative educational methods. The investigators used California Department of Public Health data on kindergarten PBE rates from 2000 to 2014 to compare annual average increases in PBE rates between schools.
Alternative schools had an average PBE rate of 8.7%, compared with 2.1% among public schools. Waldorf schools had the highest average PBE rate of 45.1%, which was 19 times higher than in public schools (incidence rate ratio = 19.1; 95% confidence interval = 16.4, 22.2). Montessori and holistic schools had the highest average annual increases in PBE rates, slightly higher than Waldorf schools (Montessori: 8.8%; holistic: 7.1%; Waldorf: 3.6%).
The authors concluded that Waldorf schools had exceptionally high average PBE rates, and Montessori and holistic schools had higher annual increases in PBE rates. Children in these schools may be at higher risk for spreading vaccine-preventable diseases if trends are not reversed.
As the world is hoping for the arrival of an effective vaccine against the corona virus, these figures should concern us.
The Lightning Process (LP) is a commercial programme developed by Phil Parker based on ideas from osteopathy, life coaching and neuro-linguistic programming. It has been endorsed by celebrities like Martine McCutcheon and Esther Rantzen, who credits it for her daughter’s recovery from ME. Parker claims that LP works by teaching people to use their brain to “stimulate health-promoting neural pathways”. One young patient once described it as follows: “Whenever you get a negative thought, emotional symptom, you are supposed to turn on one side and with your arm movements in a kind if stop motion, just say STOP very firmly and that is supposed to cut off the adrenaline response.”
Allegedly, the LP teaches individuals to recognize when they are stimulating or triggering unhelpful physiological responses and to avoid these, using a set of standardized questions, new language patterns and physical movements with the aim of improving a more appropriate response to situations. The LP involves three group sessions on consecutive days where participants are taught theories and skills, which are then practised through simple steps, posture and coaching.
A few days ago, someone asked my help writing to me: Norwegian newspaper is attacking patients for objecting to a clinical trial of the lightning process which is horrible quackery. LP is being backed by some people in Norwegian health authorities. Could you bring attention to how disgraceful this is please? I promised to look into it. Hence this post.
My searches located just one single trial. It seems to be the only controlled clinical study available. Here it is:
Design: Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.
Setting: Specialist paediatric CFS/ME service.
Patients: 12-18 year olds with mild/moderate CFS/ME.
Main outcome measures: The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.
Results: We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.
Conclusion: The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.
The trial was designed as an ‘A+B versus B’ study which practically always generates a positive outcome. It did not control for placebo effects and is, in my humble view, worthless and arguably unethical. It certainly does not warrant the conclusion that LB is effective or cost-effective.
I do not doubt that the LP-children improved, but I see no reason to believe that this had anything to do with LP. It could have been (and most likely was) caused by the intense attention that these kids received over three days. Giving them a daily ice-cream and some kindness might (and probably would) have produced even better outcomes.
So, what do we call a therapy for which numerous, far-reaching claims are being made, which is based on implausible assumptions, which is unproven, and for which people have to pay dearly?
The last time I looked, it was called quackery.
When I first saw this press-release, I thought it was a hoax. After all, it came from a most dubious homeopathic source. Then I read it again and was no longer sure.
What do you think?
Here it is in full:
Santa Clara, Cuba, April 3,2020 (Prensa Latina) The homeopathic medicine Prevengho-VIR began to be administered as a measure to confront the Covid-19 in this province of central Cuba.
Dr. Mirtha Rosa Hernandez, head of the Department of the Elderly in Villa Clara, reported that the supply of the preparation began in the Grandparents’ Homes and Elderly Homes of the territory, which has 184,000 people over 60 years old, 23.9 percent of the local universe. The medicine is administered by doctors and nurses of the basic working group where the Grandparents’ Homes and Nursing Homes are located in the 13 municipalities of this province.
This homeopathic medicine comes in a 10-milliliter bottle, and the daily dosage is 5 drops, thrice a day; while on the tenth day a reactivation of the initial dose is performed. It is aimed at preventing the respiratory diseases in this risk group, in addition to other medical conditions, such as dengue.
In the upcoming days it will be extended to the Maternal Homes. It is administered by the doctors and the nurses from the basic work group of the senior homes.
She said, that besides avoiding the new coronavirus the formula is also aimed at preventing respiratory diseases in this risk group, in addition to others such as dengue fever.
This medicine can also be administered to children under 10 years old, pregnant women, nursing mothers, and patients with liver disorders.
Anas berberiae 200
Baptisia tinctora 200
Eupetorium perf 200
Arsenicum Album 200
As I said, I was not sure whether this was for real. Is it possible that even officials are so stupid, brainwashed or gullible to go for homeopathy in such a serious situation?
In an attempt to find out, I did a little search and quickly found that the story has been reported by multiple media. This, for instance, is what the Miami Herald reported:
As scientists around the world speed up clinical trials to find a cure or vaccine for the coronavirus, the Cuban government will begin distributing a homeopathic remedy to the elderly and other vulnerable people to “prevent” the spread of the disease, a top health official said.
Dr. Francisco Durán, national director of Epidemiology at the Ministry of Public Health, said in a press conference on Sunday that “sublingual drops” of the compound PrevengHo-Vir “prevent different diseases such as influenza, the common cold, dengue, and emerging viral infections such as this one.”
On Monday, Durán tried to correct his statements and said that the product “does not prevent contagion” but rather “increases resistance, the body’s defenses against a certain virus.”
Several state media outlets reported that PrevengHo-Vir is already being used in various Cuban provinces to treat the elderly and other groups vulnerable to the coronavirus. There is no internet record of PrevengHo-Vir, other than press reports about the announcement of its distribution in Cuba.
So, it’s not a hoax!
In this case, let me try to predict what will happen next:
- When the pandemic is over, the Cubans will publish mortality rates achieved with their homeopathic prevention [A].
- They will compare them to data from a cohort that did not receive the homeopathic treatment [B].
- Neither of the data-sets will be transparent and nobody will be able to check its reliability.
- The comparison will yield a significant difference in favour of homeopathy.
- The Cubans will use this to market their remedy.
- The world of homeopathy will use it as a proof that homeopathy is effective (it wouldn’t be the first time).
Nothing wrong with that, some will say. Others who understand research methodology will, however, point out that these data are less than convincing.
In such case/control studies, one large group of patients [A] is compared to another group [B]. Group A has been treated homeopathically, while group B received no homeopathy. Any difference in outcome between A and B might be due to a range of circumstances that are unrelated to the homeopathic treatment, for instance:
- group A might have been less ill than group B,
- group A might have been better nourished,
- group A might have benefited from better hygiene,
- group A might have received better care,
- group B might have received treatments that made the situation not better but worse,
- the researchers might have prettified the data to make group A look better.
Such concerns are not totally unfounded; after all, Cuba seems to have a long history of making irresponsible claims for their homeopathic products.