MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

prevention

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The concept of ultra-processed food (UPF) was initially developed and the term coined by the Brazilian nutrition researcher Carlos Monteiro, with his team at the Center for Epidemiological Research in Nutrition and Health (NUPENS) at the University of São Paulo, Brazil. They argue that “the issue is not food, nor nutrients, so much as processing,” and “from the point of view of human health, at present, the most salient division of food and drinks is in terms of their type, degree, and purpose of processing.”

Examples of UPF include:

Ultra-processed food is bad for our health! This message is clear and has been voiced so many times – not least by proponents of so-called alternative medicine (SCAM) – that most people should now understand it.

But how bad?

And what diseases does UPF promote?

How strong is the evidence?

I did a quick Medline search and was overwhelmed by the amount of research on this subject. In 2022 alone, there were more than 2000 publications! Here are the conclusions from just a few recent studies on the subject:

Don’t get me wrong: this is not a systematic review of the subject. I am merely trying to give a rough impression of the research that is emerging. A few thoughts seem nonetheless appropriate.

  1. The research on this subject is intense.
  2. Even though most studies disclose associations and not causal links, there is in my view no question that UPF aggravates many diseases.
  3. The findings of the current research are highly consistent and point to harm done to most organs.
  4. Even though this is a subject on which advocates of SCAM are exceedingly keen, none of the research I saw was conducted by SCAM researchers.
  5. The view of many SCAM proponents that conventional medicine does not care about nutrition is clearly not correct.
  6. Considering how unhealthy UPF is, there seems to be a lack of effective education and action aimed at preventing the harm UPF does to us.

Drip IV is “Australia’s first and leading mobile healthcare company specialising in assisting with nutritional deficiencies”. They claim to provide a mobile IV service that is prescribed and tailored individually to your nutritional needs. Treatment plans and customised infusions are determined by a medical team to suit individual requirements. They deliver vitamins, minerals and amino acids directly to the body via the bloodstream, a method they state allows for optimal bioavailability.

These claims are a little puzzling to me, not least because vitamins, minerals and amino acids tailored individually to the nutritional needs of the vast majority of people would mean administering nothing at all. But I guess that virtually every person who consults the service will get an infusion [and pay dearly for it].

The Australian Therapeutic Goods Administration (TGA) seems to have a similarly dim view on Drip IV. The TGA has just issued 20 infringement notices totalling $159,840 to the company and to one of its executive officers. The reason: unlawful advertising of intravenous infusion products to Australian consumers on a company website and social media. Ten notices totalling $133,200 were issued to the company and ten notices totalling $26,640 were issued to an executive officer. The TGA considers the intravenous infusion products to be therapeutic goods because of the claims made about them, and the advertising to be unlawful because the advertisements allegedly:

  • contained prohibited representations, such as claims regarding cancer.
  • contained restricted representations such as that the products would alleviate fatigue caused by COVID-19, assist in the treatment of Graves’ Disease and Alzheimer’s Disease, and support the treatment of autoimmune diseases such as Multiple Sclerosis. No TGA approval had been given to make such claims.
  • referred to ingredients that are prescription only, such as glutathione. Prescription medicines cannot be advertised directly to the public in Australia.
  • contained a statement or picture suggesting or implying the products were ‘TGA Approved’. Advertising of therapeutic goods cannot include a government endorsement.
  • contained a statement or picture expressing that the goods were ‘miraculous’.

Vitamin infusions have become very popular around the globe. There are now thousands of clinics offering this service, and many of them advertise aggressively with claims that are questionable. Here is just one example from the UK:

Modern life is hectic. If you are looking to boost your wellbeing, increase your energy levels, lift your mood and hydrate your body, Vitamin IV Infusions are ideal. Favoured by celebrities such as Madonna, Simon Cowell and Rihanna, Vitamin IV Infusions are an easy, effective way of delivering vitamins, minerals and amino acids directly into your bloodstream via an IV (intravenous) drip. Vitamins are essential for normal growth and staying healthy – but our bodies can’t produce all of the nutrients we need to function and thrive. That’s why more than one in three people take daily vitamin supplements – often without realising that only 15% of the active nutrients consumed orally actually find their way into their bloodstream. With Vitamin IV Infusions, the nutrients enter your bloodstream directly and immediately, and are delivered straight to your cells. We offer four different Vitamin IV Infusions, so you can choose the best combination for your personal needs, while boosting your general health, energy and wellbeing.

My advice to consumers is a little different and considerably less costly:

  1. to ensure you get enough vitamins, minerals, and amino acids, eat a balanced diet;
  2. to boost your well-being, sit down and calculate the savings you made by NOT using such a service;
  3. to increase your energy levels, take a nap;
  4. to lift your mood, recount the money you saved and think of what nice things you might buy with it;
  5. to hydrate your body drink a glass of water.

Perhaps it is time the authorities in all countries had a look at what these clinics are offering and what health claims they are making. Perhaps it is time they act as the TGA just did.

 

The UK medical doctor, Sarah Myhill, has a website where she tells us:

Everyone should follow the general approach to maintaining and restoring good health, which involves eating a paleo ketogenic diet, taking a basic package of nutritional supplements, ensuring a good night’s sleep on a regular basis and getting the right balance between work, exercise and rest. Because we live in an increasingly polluted world, we should probably all be doing some sort of detox regime.

She also happens to sell dietary supplements of all kinds which must surely be handy for all who want to follow her advice. Dr. Myhill boosted her income even further by putting false claims about Covid-19 treatments online. And that got her banned from practicing for nine months after a medical tribunal.

She posted videos and articles advocating taking vitamins and other substances in high doses, without evidence they worked. The General Medical Council (GMC) found her recommendations “undermined public health” and found some of her recommendations had the potential to cause “serious harm” and “potentially fatal toxicity”. The tribunal was told she uploaded a series of videos and articles between March and May 2020, describing substances as “safe nutritional interventions” which she said meant vaccinations were “rendered irrelevant”. But the substances she promoted were not universally safe and have potentially serious health risks associated with them, the panel was told. The tribunal found Dr. Myhill “does not practice evidence-based medicine and may encourage false reassurance in her patients who may believe that they will not catch Covid-19 or other infections if they follow her advice”.

Dr. Myhill previously had a year-long ban lifted after a General Medical Council investigation into her claims of being a “pioneer” in the treatment of chronic fatigue syndrome. In fact, the hearing was told there had been 30 previous GMC investigations into Dr. Myhill, but none had resulted in findings of misconduct.

Dr. Myhill is also a vocal critic of the PACE trial and biopsychosocial model of ME/CFS. Dr. Myhill’s GMC complaint regarding a number of PACE trial authors was first rejected without investigation by the GMC, after Dr. Myhill appealed the GMC stated they would reconsider. Dr. Myhill’s action against the GMC for failing to provide reasoning for not investigating the PACE trial authors is still continuing and began a number of months before the most recent GMC instigation of her practice started.

The recent tribunal concluded: “Given the circumstances of this case, it is necessary to protect members of the public and in the public interest to make an order suspending Dr. Myhill’s registration with immediate effect, to uphold and maintain professional standards and maintain public confidence in the profession.”

This prospective study aimed to identify an optimal lifestyle profile to protect against memory loss in older individuals from areas representative of the north, south, and west of China. Individuals aged 60 years or older who had normal cognition and underwent apolipoprotein E (APOE) genotyping at baseline in 2009 were included. Participants were followed up until death, discontinuation, or 26 December 2019.

Six lifestyle factors were assessed:

  • a healthy diet (adherence to the recommended intake of at least 7 of 12 eligible food items),
  • regular physical exercise (≥150 min of moderate intensity or ≥75 min of vigorous intensity, per week),
  • active social contact (≥twice per week),
  • active cognitive activity (≥twice per week),
  • never or previously smoked,
  • never drinking alcohol.

Participants were categorised into the favourable group if they had 4-6 healthy lifestyle factors, into the average group for two to three factors, and into the unfavourable group for zero to one factor.

Memory function was assessed using the World Health Organization/University of California-Los Angeles Auditory Verbal Learning Test, and global cognition was assessed via the Mini-Mental State Examination. Linear mixed models were used to explore the impact of lifestyle factors on memory in the study sample.

A total of 29 072 participants were included (mean age of 72.23 years; 48.54% (n=14 113) were women; and 20.43% (n=5939) were APOE ε4 carriers). Over the 10-year follow-up period (2009-19), participants in the favourable group had slower memory decline than those in the unfavourable group (by 0.028 points/year, 95% confidence interval 0.023 to 0.032, P<0.001). APOE ε4 carriers with favourable (0.027, 95% confidence interval 0.023 to 0.031) and average (0.014, 0.010 to 0.019) lifestyles exhibited a slower memory decline than those with unfavourable lifestyles. Among people who were not carriers of APOE ε4, similar results were observed among participants in the favourable (0.029 points/year, 95% confidence interval 0.019 to 0.039) and average (0.019, 0.011 to 0.027) groups compared with those in the unfavourable group. APOE ε4 status and lifestyle profiles did not show a significant interaction effect on memory decline (P=0.52).

The authors concluded that a healthy lifestyle is associated with slower memory decline, even in the presence of the APOE ε4 allele. This study might offer important information to protect older adults against memory decline.

This is an important and meticulously reported study. It is the first large-scale investigation that assesses the effects of different lifestyle profiles, APOE ε4 status, and their interactions on longitudinal memory trajectories over a 10-year follow-up period. The results show that lifestyle is associated with the rate of memory decline in cognitively normal older individuals, including in people who are genetically susceptible to memory decline. The authors are rightly careful to avoid causal inferences between lifestyle and memory decline. To demonstrate causality beyond doubt, we would need different study designs.

The authors also discuss several weaknesses of the study:

  • Firstly, the assessments of lifestyle factors were based on self-reports and are, therefore, prone to measurement errors.
  • Secondly, several participants were excluded due to missing data or not returning for follow-up evaluations, which might have led to selection bias.
  • Thirdly, the proportion of individuals with an unhealthy lifestyle might have been underestimated in the study because people with poor health were less likely to have participated in the study.
  • Fourthly, given the nature of the study design, it could not assess whether maintaining a healthy lifestyle had already started influencing memory by the time of enrolment in the study.
  • Fifthly, the evaluation of memory using a single neuropsychological test that does not comprehensively reflect overall memory function. However, the Auditory Verbal Learning Test is an effective instrument for memory assessment, and a composite score was used based on four Auditory Verbal Learning Test subscales to represent memory conditions to the greatest extent possible.
  • Sixthly, as participants might become familiar with repeated cognitive testing, a learning effect could have influenced the results.
  • Finally, memory decline was studied solely among older adults; however, memory problems commonly affect young individuals as well.

The authors, therefore, state that further studies should be conducted to facilitate a more extensive investigation into the effects of a healthy lifestyle on memory decline across the lifespan. This approach would help to elucidate the crucial age window during which a healthy lifestyle can exert the most favourable effect.

Migraines are common headache disorders and risk factors for subsequent strokes. Acupuncture has been widely used in the treatment of migraines; however, few studies have examined whether its use reduces the risk of strokes in migraineurs. This study explored the long-term effects of acupuncture treatment on stroke risk in migraineurs using national real-world data.

A team of Taiwanese researchers collected new migraine patients from the Taiwan National Health Insurance Research Database (NHIRD) from 1 January 2000 to 31 December 2017. Using 1:1 propensity-score matching, they assigned patients to either an acupuncture or non-acupuncture cohort and followed up until the end of 2018. The incidence of stroke in the two cohorts was compared using the Cox proportional hazards regression analysis. Each cohort was composed of 1354 newly diagnosed migraineurs with similar baseline characteristics. Compared with the non-acupuncture cohort, the acupuncture cohort had a significantly reduced risk of stroke (adjusted hazard ratio, 0.4; 95% confidence interval, 0.35–0.46). The Kaplan–Meier model showed a significantly lower cumulative incidence of stroke in migraine patients who received acupuncture during the 19-year follow-up (log-rank test, p < 0.001).

The authors concluded that acupuncture confers protective benefits on migraineurs by reducing the risk of stroke. Our results provide new insights for clinicians and public health experts.

After merely 10 minutes of critical analysis, ‘real-world data’ turn out to be real-bias data, I am afraid.

The first question to ask is, were the groups at all comparable? The answer is, NO; the acupuncture group had

  • more young individuals;
  • fewer laborers;
  • fewer wealthy people;
  • fewer people with coronary heart disease;
  • fewer individuals with chronic kidney disease;
  • fewer people with mental disorders;
  • more individuals taking multiple medications.

And that are just the variables that were known to the researcher! There will be dozens that are unknown but might nevertheless impact on a stroke prognosis.

But let’s not be petty and let’s forget (for a minute) about all these inequalities that render the two groups difficult to compare. The potentially more important flaw in this study lies elsewhere.

Imagine a group of people who receive some extra medical attention – such as acupuncture – over a long period of time, administered by a kind and caring therapist; imagine you were one of them. Don’t you think that it is likely that, compared to other people who do not receive this attention, you might feel encouraged to look better after your health? Consequently, you might do more exercise, eat more healthily, smoke less, etc., etc. As a result of such behavioral changes, you would be less likely to suffer a stroke, never mind the acupuncture.

SIMPLE!

I am not saying that such studies are totally useless. What often renders them worthless or even dangerous is the fact that the authors are not more self-critical and don’t draw more cautious conclusions. In the present case, already the title of the article says it all:

Acupuncture Is Effective at Reducing the Risk of Stroke in Patients with Migraines: A Real-World, Large-Scale Cohort Study with 19-Years of Follow-Up

My advice to researchers of so-called alternative medicine (SCAM) and journal editors publishing their papers is this: get your act together, learn about the pitfalls of flawed science (most of my books might assist you in this process), and stop misleading the public. Do it sooner rather than later!

Chronic kidney disease is common, often progressive, and difficult to treat or prevent. Effective interventions would therefore be more than welcome. This paper explored the relation of habitual fish oil use with the risk of chronic kidney diseases (CKD).

A total of 408,023 participants (54.2% female) without prior CKD and with completed information regarding their consumption of major food groups and fish oil in the UK Biobank were enrolled. Fish oil use and dietary intakes were assessed by touch screen questionnaire and food frequency questionnaire, respectively. Incident CKD was recorded from hospital inpatient records.

At baseline, 128,843 (31.6%) participants reported taking fish oil supplements. During a median follow-up period of 12.0 years, a total of 10,782 (2.6%) participants developed CKD. With adjustments for important confounders, habitual fish oil use was associated with a significantly lower hazard of incident CKD (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.87-0.95), compared with non-use. Consistently, participants reporting ≥2 servings/week of oily fish (HR, 0.86; 95% CI, 0.79-0.94) and nonoily fish (HR, 0.86; 95% CI, 0.77-0.97) consumption had a lower hazard of incident CKD compared to those reporting no consumption ever. Additionally, among the 97,914 participants with data on plasma fatty acid, there were significant inverse relationships of plasma omega-3 polyunsaturated fatty acid (PUFA) (per SD increment, HR, 0.89, 95% CI, 0.84-0.94) and eicosatetraenoic acid (per SD increment, HR, 0.91, 95% CI, 0.87-0.96) with incident CKD.

The authors concluded that habitual fish oil use was associated with a lower hazard of CKD, which was further confirmed by the consistent inverse relations between fish consumption and circulating omega-3 PUFA concentration with incident CKD.

I like this paper! It shows in an exemplary fashion how to interpret an association between two variables: fish oil consumption does not necessarily CAUSE the lower risk, it is merely associated with it and there might be a number of non-causal explanations for the link. Whether there is a true cause-effect relationship needs to be investigated in further, differently designed studies. The present paper does not overstate its conclusions but it is nevertheless important, as it hopefully will prompt others to clarify the crucial issue of causality.

Wouldn’t it be nice, if researchers of so-called alternative medicine (SCAM) finally learned this simple lesson?

We have discussed the UK conservative MP and arch-Brexiteer, Andrew Bridgen, and his anti-vax stance before. Yesterday, it has been reported that he lost the Tory whip, i.e. he was expelled from the Tory party. The reason for this step is that he had taken to social media and claimed the Covid vaccine to be the “biggest crime against humanity since the holocaust”.

The North West Leicestershire MP has been vocal in remarks questioning the coronavirus vaccine.

On Wednesday he shared an article on vaccines on Twitter, adding: “As one consultant cardiologist said to me, this is the biggest crime against humanity since the Holocaust.”

Renouncing Bridgen’s right to sit as a Tory MP in Parliament, Conservative chief whip Simon Hart said: “Andrew Bridgen has crossed a line, causing great offence in the process. “As a nation, we should be very proud of what has been achieved through the vaccine programme. The vaccine is the best defence against Covid that we have. “Misinformation about the vaccine causes harm and costs lives. I am therefore removing the whip from Andrew Bridgen with immediate effect, pending a formal investigation.”

Earlier, former Cabinet minister Simon Clarke had condemned his colleague’s tweet referencing the Holocaust, calling it “disgraceful”.

Bridgen is currently already suspended from the Commons after he was found to have displayed a “very cavalier” attitude to the rules in a series of lobbying breaches. MPs agreed on Monday to suspend the North West Leicestershire MP for five sitting days from Tuesday.

Comments from different sources are not flattering for Bridgen:

  • Karen Pollock, the chief executive of the Holocaust Educational Trust, said Bridgen’s tweet was “highly irresponsible, wholly inappropriate and an elected politician should know better”.
  • Anneliese Dodds, the Labour chair, said: “Andrew Bridgen has been spreading dangerous misinformation on Covid vaccines for some time now. He could have been disciplined weeks ago. “To invoke the Holocaust, as he did today, is utterly shameful, but it should never have reached this point.”
  • Andrew Percy, the Conservative MP who is vice-chair of the all-party group against antisemitism, called the comment “disgusting”. Asked by Times Radio if Bridgen should be allowed to stand again, Percy said: “I don’t think anybody who believes this kind of crap should, but that’s a matter for the whips not for me.”
  • John Mann, the former Labour MP who is now a non-affiliated peer and the government’s independent adviser on antisemitism, said Bridgen should not be allowed to stand again as a Tory. “There is no possibility that Bridgen can be allowed to stand at the next election,” he said. “He cannot claim that he didn’t realise the level of offence that his remarks cause.”

____________________________

To the best of my knowledge, this is the first time that a UK politician has been punished in this way. But it may well be also the first time that a sitting UK politician has uttered such insane stupidity. Bridgen’s chronic ineptitude is all the more significant as he really should know better. He studied genetics and behaviour at the University of Nottingham and graduated with a degree in biological sciences!

Here are some reactions from people commenting on Twitter about the twit:

  • Tory MP, Andrew Bridgen highlights… – Lies in court over family dispute and ordered by judge to pay £800k – Suspended for breaching MP lobbying rules – Thought all Brits entitled to Irish passport after Brexit – Likens vaccines to holocaust What a guy.
  • Spreads a dangerous, baseless smear his party colluded in a vaccine Holocaust and at the same time manages to insults victims of a grotesque wartime Holocaust. Conspiracy theorist Andrew Bridgen’s lost the plot. See no way back for the Tory MP now.
  • Grubby and despicable: Tory MP Andrew Bridgen loses whip over ‘dangerous’ Covid vaccine claims
  • To be fair, Bridgen kept the whip after saying the MI5 knew about the pandemic six months early, then colluded with shadowy elites to impose needless restrictions for their own nefarious ends. So the bar is high.
  • Politicians like Andrew Bridgen have succeeded in bringing conspiracy theories into the mainstream. They need to be called out, their arguments dismantled and their political influence cast out to the fringes where it belongs.
  • A Holocaust survivor has condemned a Tory MP’s “mind-boggling ignorance” after he compared the mass genocide of Jewish people during World War II to the COVID vaccine rollout
  • Many congratulations to Andrew Bridgen on his imminent selection as the Reform Party candidate for North West Leicestershire in the 2024 election
  • Andrew Bridgen. Perjury, bullying, misuse of money, months of anti-vaccine garbage, finally loses whip after comparing vaccination to the Holocaust. Scum.
  • Six million Jews were murdered in the Holocaust. COVID vaccines have saved millions. The false and outrageous comparisons must end.
  • Andrew Bridgen suspended as Tory MP he said: “As one consultant cardiologist said to me, this is the biggest crime against humanity since the Holocaust.” Crucially a cardiologist saying this too. Who are they? Should GMC act in same way as Whips Office?

The prime candidate for the cardiologist in question must, of course, be Aseem Malhotra who also appeared on September 27, 2022, in a press conference with the World Council for Health — a group that has previously spread vaccine misinformation — to call for the “immediate and complete suspension of Covid-19 vaccine.”

Who was it that coined the bon mot: We were all born ignorant but to remain so requires hard work

I have tried!

Honestly!

But at present, it is simply not possible to escape the revelations and accusations by Harry Windsor.

So, eventually, I gave in and had a look at the therapy he often refers to. He claims that he is deeply traumatized by what he had to go through and, to help him survive the ordeal, Harry has been reported to use EMDR.

Eye Movement Desensitization and Reprocessing (EMDR) is a fringe psychotherapy that was developed to alleviate the distress associated with traumatic memories. It is supposed to facilitate the accessing and processing of traumatic memories and other adverse life experiences with a view of bringing these to an adaptive resolution. The claim is that, after successful treatment with EMDR therapy, affective distress is relieved, negative beliefs are reformulated, and physiological arousal is reduced.

During EMDR therapy the patient must attend to emotionally disturbing material in brief sequential doses while simultaneously focusing on an external stimulus. Therapist-directed lateral eye movements are commonly used as external stimulus but a variety of other stimuli including hand-tapping and audio stimulation can also be employed.

Francine Shapiro, the psychologist who invented EMDR claims to have serendipitously discovered this technique by experiencing spontaneous saccadic eye movements in response to disturbing thoughts during a walk in the woods. Yet, as GM Rosen explains, this explanation is difficult to accept because normal saccadic eye movements appear to be physiologically undetectable and are typically triggered by external stimuli.

Shapiro hypothesizes that EMDR therapy facilitates the access to the traumatic memory network, so that information processing is enhanced, with new associations forged between the traumatic memory and more adaptive memories or information. These new associations are alleged to result in complete information processing, new learning, elimination of emotional distress, and development of cognitive insights.

EMDR therapy uses a three-pronged protocol:

  • (1) the past events that have laid the groundwork for dysfunction are processed, forging new associative links with adaptive information;
  • (2) the current circumstances that elicit distress are targeted, and internal and external triggers are desensitized;
  • (3) imaginal templates of future events are incorporated, to assist the client in acquiring the skills needed for adaptive functioning.

The question I ask myself is, of course: Does EMDR work?

The evidence is mixed and generally flimsy. A systematic review showed that “limitations to the current evidence exist, and much current evidence relies on small sample sizes and provides limited follow-up data”.

What might be particularly interesting in relation to Harry Windsor is that EMDR techniques have been associated with memory-undermining effects and may undermine the accuracy of memory, which can be risky if patients, later on, serve as witnesses in legal proceedings.

Personally, I think that Harry’s outbursts lend support to the hypothesis that EMDR is not effective. In the interest of the royal family, we should perhaps see whether so-called alternative medicine (SCAM) does offer an effective treatment against navel gazing?

When I conduct my regular literature searches, I am invariably delighted to find a paper that shows the effectiveness of a so-called alternative medicine (SCAM). Contrary to the impression that I might give to some, I like positive results as much as the next person. So, today you find me pleased to yet again report about one of my favorite SCAMs.

The purpose of this systematic review was to evaluate the effectiveness of manual lymphatic drainage (MLD) in breast cancer-related lymphedema (BCRL) patients.

In total, 11 RCTs involving 1564 patients could be included, and 10 trials were deemed viable for inclusion in the meta-analysis. Due to the effects of MLD for BCRL, statistically significant improvements were found on the incidence of lymphedema (RR = 0.58, 95% CI [0.37, 0.93], P =.02) and pain intensity (SMD = -0.72, 95% CI [-1.34, -0.09], P = .02). Besides, the meta-analysis carried out implied that the effects that MLD had on volumetric changes of lymphedema and quality of life, were not statistically significant.

The authors concluded that the current evidence based on the RCTs shows that pain of BCRL patients undergoing MLD is significantly improved, while our findings do not support the use of MLD in improving volumetric of lymphedema and quality of life. Note that the effect of MLD for preventing BCRL is worthy of discussion.

Lymph drainage is so well-established in cancer care that most people would probably consider it a conventional treatment. If, however, you read for which conditions its inventor, Emil Vodder, used to promote it, they might change their minds. Vodder saw it as a cure for most illnesses, even those for which there is no plausibility or good evidence.

As far as I can see, lymph drainage works well for reducing lymph edema but, for all other conditions, it is not evidence-based. And this is the reason why I still categorize it as a SCAM.

This Cochrane review assessed the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections (ARTIs) in children.

The researchers included double‐blind randomized clinical trials (RCTs) or double‐blind cluster‐RCTs comparing oral homeopathy medicinal products with placebo or self‐selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years.

In this 2022 update, the researchers identified three new RCTs involving 251 children, for a total of 11 included RCTs with 1813 children receiving oral homeopathic medicinal products or a control treatment for ARTIs. All studies focused on upper respiratory tract infections (URTIs), with only one study including some lower respiratory tract infections (LRTIs). Six RCTs examined the effect on URTI recovery, and five RCTs investigated the effect on preventing URTIs after one to four months of treatment. Two treatment and three prevention studies involved homeopaths individualizing treatment. The other studies used predetermined, non-individualized remedies. All studies involved highly diluted homeopathic medicinal products, with dilutions ranging from 1 x 10‐4 to 1 x 10‐200.

Several limitations to the included studies were identified, in particular methodological inconsistencies and high attrition rates, failure to conduct intention‐to‐treat analysis, selective reporting, and apparent protocol deviations. Three studies were classified as at high risk of bias in at least one domain, and many studies had additional domains with unclear risk of bias. Four studies received funding from homeopathy manufacturers; one study support from a non‐government organization; two studies government support; one study was co‐sponsored by a university; and three studies did not report funding support.

Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta‐analysis. Only four outcome variables were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products, whilst trials at unclear or high risk of bias reported beneficial effects. For the comparison of individualized homeopathy versus placebo or usual care for the prevention of ARTIs, two trials reported on disease severity; due to heterogeneity the data were not combined, but neither study demonstrated a clinically significant difference. For the comparison of non-individualized homeopathy versus placebo or usual care for the prevention of ARTIs, only the outcome recurrence of ARTI was reported by more than one trial. For the comparison of both individualized and non-individualized homeopathy versus placebo or usual care for the treatment of ARTIs, two studies provided data on short‐term cure (OR 1.31, 95% CI 0.09 to 19.54) and long‐term cure (OR 1.01, 95% CI 0.10 to 9.96; very low‐certainty evidence). The studies demonstrated an opposite direction of effect for both outcomes. Six studies reported on disease severity but were not combined as they used different scoring systems and scales. Three studies reported adverse events (OR 0.79, 95% CI 0.16 to 4.03; low‐certainty evidence).

The authors concluded that the “pooling of five prevention and six treatment studies did not show any consistent benefit of homeopathic medicinal products compared to placebo on ARTI recurrence or cure rates in children. We assessed the certainty of the evidence as low to very low for the majority of outcomes. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, and we could not draw conclusions regarding safety.”

____________________________

These findings are hardly surprising. Will they change the behavior of homeopaths who feel that

  1. children respond particularly well to homeopathy,
  2. ARTIs are conditions for which homeopathy is particularly effective?

I would not hold my breath!

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