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.
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?
The impact of drug-induced liver injury (DILI) on patients with chronic liver disease (CLD) is unclear. There are few reports comparing DILI in CLD and non-CLD patients. In this study, the researchers aimed to determine the incidence and outcomes of DILI in patients with and without CLD.
They collected data on eligible individuals with suspected DILI between 2018 and 2020 who were evaluated systematically for other etiologies, causes, and the severity of DILI. They compared the causative agents, clinical features, and outcomes of DILI among subjects with and without CLD who were enrolled in the Thai Association for the Study of the Liver DILI registry. Subjects with definite, or highly likely DILI were included in the analysis.
The researchers evaluated the causal relationship between the clinical pattern of liver injury and the suspected drugs or SCAM products with the Roussel Uclaf Causality Assessment Method (RUCAM) system. RUCAM is a validated and established tool to quantitatively assess causality in cases of suspected DILI and/or SCAM product-induced liver injury. They also used the Clinical Assessment of Causality Scale to assess the association as definite (>95% likelihood), highly likely (75–95%), probable (50–74%), possible (25–49%) or unlikely (<25%).
A total of 200 subjects diagnosed with DILI were found in the registry. Of those, 41 had CLD and 159 had no evidence of CLD. So-called alternative medicine (SCAM) products were identified as the most common class of DILI agents. Approximately 59% of DILI in the CLD and 40% in non-CLD group were associated with SCAM use. Individuals with pre-existing CLD had similar severity including mortality. Twelve patients (6%) developed adverse outcomes related to DILI including seven (3.5%) deaths and five (2.5%) with liver failure. Mortality was 4.88% in CLD and 3.14% in non-CLD subjects over median periods of 58 (8-106) days and 22 (1-65) days, respectively.
The authors concluded that, in this liver disease registry, the causes, clinical presentation, and outcomes of DILI in subjects with CLD and without CLD patients were not different. Further study is required to confirm our findings.
Consumers often prefer SCAM to conventional medicine because SCAM is viewed as gentle and safe. The notions are that they
- are natural and therefore harmless;
- have been in use for ages and thus have stood the test of time.
Readers of this blog will appreciate that both notions are, in fact, fallacies:
- appeal to nature;
- appeal to tradition.
This new paper is an impressive reminder that SCAM’s reputation as a safe option is not justified, and that SCAM relies more on fallacies than on facts.
Gut microbiota can influence health through the microbiota–gut–brain axis. Meditation can positively impact the regulation of an individual’s physical and mental health. However, few studies have investigated fecal microbiota following long-term (several years) deep meditation. Therefore, this study tested the hypothesis that long-term meditation may regulate gut microbiota homeostasis and, in turn, affect physical and mental health.
To examine the intestinal flora, 16S rRNA gene sequencing was performed on fecal samples of 56 Tibetan Buddhist monks and neighboring residents. Based on the sequencing data, linear discriminant analysis effect size (LEfSe) was employed to identify differential intestinal microbial communities between the two groups. Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) analysis was used to predict the function of fecal microbiota. In addition, we evaluated biochemical indices in the plasma.
The α-diversity indices of the meditation and control groups differed significantly. At the genus level, Prevotella and Bacteroides were significantly enriched in the meditation group. According to the LEfSe analysis, two beneficial bacterial genera (Megamonas and Faecalibacterium) were significantly enriched in the meditation group. The functional predictive analysis further showed that several pathways—including glycan biosynthesis, metabolism, and lipopolysaccharide biosynthesis—were significantly enriched in the meditation group. Moreover, plasma levels of clinical risk factors were significantly decreased in the meditation group, including total cholesterol and apolipoprotein B.
The Chinese authors concluded that the intestinal microbiota composition was significantly altered in Buddhist monks practicing long-term meditation compared with that in locally recruited control subjects. Bacteria enriched in the meditation group at the genus level had a positive effect on human physical and mental health. This altered intestinal microbiota composition could reduce the risk of anxiety and depression and improve immune function in the body. The biochemical marker profile indicates that meditation may reduce the risk of cardiovascular diseases in psychosomatic medicine. These results suggest that long-term deep meditation may have a beneficial effect on gut microbiota, enabling the body to maintain an optimal state of health. This study provides new clues regarding the role of long-term deep meditation in regulating human intestinal flora, which may play a positive role in psychosomatic conditions and well-being.
This study is being mentioned on the BBC new-bulletins today – so I thought I have a look at it and check how solid it is. The most obvious question to ask is whether the researchers compared comparable samples.
The investigators collected a total of 128 samples. Subsequently, samples whose subjects had taken antibiotics and yogurt or samples of poor quality were excluded, resulting in 56 eligible samples. To achieve mind training, Tibetan Buddhist monks performed meditation practices of Samatha and Vipassana for at least 2 hours a day for 3–30 years (mean (SD) 18.94 (7.56) years). Samatha is the Buddhist practice of calm abiding, which steadies and concentrates the mind by resting the individual’s attention on a single object or mantra. Vipassana is an insightful meditation practice that enables one to enquire into the true nature of all phenomena. Hardly any information about the controls was provided.
This means that dozens of factors other than meditation could very easily be responsible for the observed differences; nutrition and lifestyle factors are obvious prime candidates. The fact that the authors fail to even discuss these possibilities and more than once imply a causal link between meditation and the observed outcomes is more than a little irritating, in my view. In fact, it amounts to very poor science.
I am dismayed that a respected journal published such an obviously flawed study without a critical comment and that the UK media lapped it up so naively.
The objective of this cross-sectional survey was to evaluate the beliefs about and attitudes toward cancer prevention of people professing vaccination skepticism or conspiracy theories. Data were collected mainly from a well-known Spanish forum and other platforms, including Reddit (English), 4Chan (English), HispaChan (Spanish), and a Spanish-language website for cancer prevention (mejorsincancer.org) from January to March 2022.
Among 1494 responders, 209 were unvaccinated against covid-19, 112 preferred so-called alternative rather than conventional medicine, and 62 reported flat earth or reptilian beliefs. Cancer beliefs were assessed using the Cancer Awareness Measure (CAM) and Cancer Awareness Measure Mythical Causes Scale (CAM-MYCS), both validated tools.
Awareness of the actual causes of cancer was greater (median CAM score 63.6%) than that of mythical causes (41.7%). The most endorsed mythical causes of cancer were:
- eating food containing additives or sweeteners,
- feeling stressed,
- eating genetically modified food.
Awareness of the actual and mythical causes of cancer among the unvaccinated, alternative medicine, and conspiracy groups was lower than among their counterparts. A median of 54.5% of the actual causes was accurately identified among each of the unvaccinated, alternative medicine, and conspiracy groups, and a median of 63.6% was identified in each of the three corresponding counterparts (P=0.13, 0.04, and 0.003, respectively). For mythical causes, medians of 25.0%, 16.7%, and 16.7% were accurately identified in the unvaccinated, alternative medicine, and conspiracy groups, respectively; a median of 41.7% was identified in each of the three corresponding counterparts (P<0.001 in adjusted models for all comparisons).
In total, 673 (45.0%) participants agreed with the statement “It seems like everything causes cancer.” No significant differences were observed among the unvaccinated (44.0%), conspiracist (41.9%), or alternative medicine groups (35.7%), compared with their counterparts (45.2%, 45.7%, and 45.8%, respectively).
The authors’ conclusions were as follows: we evaluated the patterns of beliefs about cancer among people who believed in conspiracies, rejected the covid-19 vaccine, or preferred alternative medicine. We observed that the participants who belonged to these groups were more likely to endorse mythical causes of cancer than were their counterparts but were less likely to endorse the actual causes of cancer. Almost half of the participants, whether
conspiracists or not, agreed with the statement “It seems like everything causes cancer,” which highlights the difficulty that society encounters in differentiating actual causes of cancer from mythical causes owing to mass (veridical or not) information. This suggests a direct connection between digital misinformation and consequent potential erroneous health decisions, which may represent a further preventable fraction of cancer. Cultivating oriented medical education and scientific literacy, improving online ranking algorithms, building trust, and using effective health communication and social marketing campaigns may be possible ways to tackle this complex public health threat.
This is yet another study showing that so-called alternative medicine (SCAM) usage is linked to misinformation and conspiratorial thinking in other areas. We have discussed similar findings all too often. They are hardly surprising, in my view. As I have repeatedly been trying to point out:
- SCAM use is based mainly on misinformation
- And, to a large extent, SCAM is little more than a conspiracy theory in disguise.
The best way to prevent harm must therefore be to educate the public responsibly (which, of course, is one of the main aims of this blog.
Even though most people do not think about it in this way, tea is a herbal remedy. We know that it is pleasant, but is it also effective?
This study explored the associations between tea drinking and the incident risk of type 2 diabetes mellitus(T2 DM). A dynamic prospective cohort study among a total of 27 841 diabetes-free permanent adult residents randomly selected from 2, 6, and 7 rural communities between 2006-2008, 2011-2012, and 2013-2014, respectively. Questionnaire survey, physical examination, and laboratory test were carried out among the participants. In 2018, the researchers conducted a follow-up through the electronic health records of residents. Cox regression models were applied to explore the association between tea drinking and the incident risk of T2 DM and estimate the hazard ratio(HR), and its 95%CI.
Among the 27 841 rural community residents in Deqing County, 10 726(39%) were tea drinkers, 8215 (77%) of which were green tea drinkers. A total of 883 new T2 DM incidents were identified until December 31, 2018, and the incidence density was 4.43 per 1000 person-years (PYs). The incidence density was 4.07/1000 PYs in those with tea drinking habits and 4.71/1000 PYs in those without tea drinking habits. The incidence density was 3.79/1000 PYs in those with green tea drinking habits. After controlling for sex, age, education, farming, smoking, alcohol consumption, dietary preference, body mass index, hypertension, impaired fasting glucose, and family history of diabetes, the risk of T2 DM among rural residents with tea drinking habits was 0.79 times higher than that among residents without tea drinking habits(HR=0.79, 95%CI 0.65-0.96), and the risk of T2 DM among residents with green tea drinking habits was 0.72 times higher than that among residents without tea drinking habits(HR=0.72, 95%CI 0.58-0.89). No significant associations were found between other kinds of tea and the risk of T2 DM, nor the amount of green tea-drinking.
The authors concluded that drinking green tea may reduce the risk of T2 DM among adult population in rural China.
Epidemiological studies of this nature resemble big fishing expeditions that can bring up all sorts of rubbish and – if lucky – also some fish. The question thus is whether this study identified an interesting association or just some odd rubbish.
A quick look into Medline seems to suggest great caution. Here are the conclusions from a few further case-control studies:
- In Chinese adults, daily green tea consumption was associated with a lower risk of incident T2D and a lower risk of all-cause mortality in patients with diabetes, but the associations for other types of tea were less clear. In addition, daily tea consumption was associated with a lower risk of diabetic microvascular complications, but not macrovascular complications.
- Green tea drinking was associated with an increased risk of T2D in Chinese adults. The mechanisms underlying the association need to be elucidated.
- Tea consumers had reduced risks of all-cause mortality and partial cause-specific mortality, but not for the risk of death from cancer. On the contrary, daily tea drinkers with smoking habits and excessive alcohol drinking had an increased risk of death from cancer.
Thus the question of whether tea drinking might prevent diabetes remains open, in my view.
Yet, the paper might teach us two important lessons:
- Case-control studies must be taken with a pinch of salt.
- Correlation is not the same as causation.
Ischemic heart disease (IHD) related to cardiovascular or cerebrovascular disease is the leading cause of mortality and an important issue of public health worldwide. The cost of long-term healthcare for IHD patients may result in a huge financial burden. This study analyzed the medical expenditure incurred for and survival of IHD patients treated with Chinese herbal medicine (CHM) and Western medicine.
Subjects were randomly selected from the National Health Insurance Research Database in Taiwan. The Cox proportional hazards regression model, Kaplan–Meier estimator, logrank test, chi-square test, and analysis of variance were applied. Landmark analysis was used to assess the cumulative incidence of death in IHD patients.
A total of 11,527 users were identified as CHM combined with Western medicine and 11,527 non-CHM users. CHM users incurred a higher medical expenditure for outpatient care within 1 (24,529 NTD versus 18,464 NTD, value <0.0001) and 5 years (95,345 NTD versus 60,367 NTD, value <0.0001). However, CHM users had shorter hospitalizations and lower inpatient medical expenditure (7 days/43,394 NTD in 1 year; 11 days/83,141 NTD in 5 years) than non-CHM users (11 days/72,939 NTD in 1 year; 14 days/107,436 NTD in 5 years).
The CHM group’s adjusted hazard ratio for mortality was 0.41 lower than that of the non-CHM group by Cox proportional hazard models with time-dependent exposure covariates. Danshen, Huang qi, Niu xi, Da huang, and Fu zi were the most commonly prescribed Chinese single herbs; Zhi-Gan-Cao-Tang, Xue-Fu-Zhu-Yu-Tang, Tian-Wang-Bu-Xin-Dan, Sheng-Mai-San, and Yang-Xin-Tang were the five most frequently prescribed herbal formulas in Taiwan.
The authors concluded that combining Chinese and Western medicine can reduce hospital expenditure and improve survival for IHD patients.
Why, you will ask, do I think that this study deserves to be in the ‘worst paper cometition’?
It is not so bad!
It is an epidemiological case-control study with a large sample size that generates interesting findings.
But, as a case-control study, it cannot establish a causal link between CHM and the outcomes. You might argue that the conclusions avoid doing this – “can … improve survival” is not the same as “does improve survival”. This may be true, yet the title of the article leaves little doubt about the interpretation of the authors:
Chinese Herbal Medicine as an Adjunctive Therapy Improves the Survival Rate of Patients with Ischemic Heart Disease: A Nationwide Population-Based Cohort Study
I find it difficult not to view this as a deliberate attempt of the authors, editors, and reviewers to mislead the public.
Looking at the details of the study, it is easy to see that the two groups were different in a whole range of parameters that were measured. More importantly, they most likely differ in a range of variables that were not measured and had significant influence on IHD survival. It stands to reason, for instance, that patients who elected to use CHM in addition to their standard care were more health conscious. They would thus have followed a healthier diet and lifestyle. It would be foolish to claim that such factors do not influence IHD survival.
The fact that the authors fail even to mention this possibility, interpret an association as a causal link, and thus try to mislead us all makes this paper, in my view, a strong contender for my
WORST PAPER OF 2022 COMPETITION
This cohort study was designed as undertaken to evaluate the protective effect of Arsenicum album 30C against COVID-19.
Participants were enrolled in a homeopathy intervention (HI) cohort (who received Arsenicum album) or in a non-intervention (NI) cohort (who received no systematic intervention) from COVID-19 containment areas of Delhi. Individuals of age 5 years or above were given four medicated pills of Arsenicum album 30C, while those from 1 to 5 years old were given two medicated pills in each dose.
The analysis included 10,180 individuals residing in 11 COVID-19 containment areas in Delhi, out of which 6,590 individuals were in the HI cohort and 3,590 individuals were in the NI cohort. The overall protective effect of Arsenicum album 30C was 83% (95% confidence interval [CI], 76.77 to 88.17): 45 cases per 6,590 (8.34 per 10,000 person-weeks) in the Arsenicum album 30C group versus 143 cases per 3,590 (45.01 per 10,000 person-weeks) in the NI cohort. The protective effect of Arsenicum album 30C against laboratory-confirmed COVID-19 was 74% (95% CI, 55.08 to 85.41): 18 cases per 6,590 (3.32 per 10,000 person-weeks) in the Arsenicum album 30C group versus 38 cases per 3,590 (11.85 per 10,000 person-weeks) in the NI cohort.
The authors concluded that the use of Arsenicum album 30C was associated with some protection against probable and laboratory-confirmed COVID-19 in a containment-zone setting. Randomized controlled trials are needed to confirm or refute these results.
It is remarkable, I feel, that the authors conclude Arsenicum album 30C was associated with some protection. All too often enthusiasts of homeopathy claim a causal link where there is none – but not this time, and I wonder why.
Unfortunately, I was unable to read the full text of the paper (it’s behind a paywall and I would be grateful for anyone to make it available). Thus, I cannot comment on one of the most crucial questions related to the study: how were the patients divided into the two groups?
It is clear that it was not by randomization. Yet only randomization would have created two fully comparable groups. The most likely explanation for the findings of this trial is therefore that the two groups differed in terms of one or more prognostic factors. This would explain why a group of patients receiving a placebo (Arsenicum album C30 is a dilution of Arsenic at a ratio of 1: 1000000000000000000000000000000000000000000000000000000000000 and therefore is a pure placebo [unless, of course, one believes in homeopathic magic) experience different outcomes from those receiving nothing.
As I said, the answer can only be found by studying the precise selection criteria used in this study. Until this is cleared up, I can only say three things for sure:
- A causal link between the treatment and the result is highly unlikely.
- It is regrettable that researchers do not use randomization for potentially important trials.
- It seems unethical to encourage placebo use for the prevention of a serious illness.
I just received the full text from one of the authors. This is what they say about the allocation of the participants:
“Participants were enrolled in two cohorts: the homeopathy intervention (HI) cohort and the non-intervention (NI) cohort. Recruitment to the cohorts was at cluster level (containment area): the clusters were allotted to the HI cohort or the NI cohort as per convenience.”
I am afraid, this tells me very little, and my concerns noted above still apply.
A few other points are of relevance:
- The study was conducted between April and August 2020. This begs the question of why it took 2 years to publish the findings.
- The outcomes were verified via telephone. This means that social desirability might have influenced the results.
- The paper also confirms that there were many important differences between the groups that might have prognostic significance.
- The conclusion at the end of the paper does imply causality in stronger terms than the abstract: “The use of Arsenicum album 30C may help protect against COVID-19 infection. Randomized controlled trials are needed
to confirm or refute our findings.
An epidemiological study from the US just published in the BMJ concluded that “the mortality gap in Republican voting counties compared with Democratic voting counties has grown over time, especially for white populations, and that gap began to widen after 2008.”
In a BMJ editorial, Steven Woolf comments on the study and provides further evidence on how politics influence health in the US. Here are his concluding two paragraphs:
Political influence on US mortality rates became overt during the covid-19 pandemic, when public health policies, controlled by states, were heavily influenced by party affiliation. Republican politicians, often seeking to appeal to President Trump and his supporters, challenged scientific evidence and opposed enforcement of vaccinations and safety measures such as masking. A macabre natural experiment occurred in 2021, a year marked by the convergence of vaccine availability and contagious variants that threatened unvaccinated populations: states led by governors who promoted vaccination and mandated pandemic control measures experienced much lower death rates than the “control” group, consisting of conservative states with lax policies and large unvaccinated populations. This behavior could explain why US mortality rates associated with covid-19 were so catastrophic, vastly exceeding losses in other high income countries.
Observers of health trends in the US should keep their eye on state governments, where tectonic shifts in policy are occurring. While gridlock in Washington, DC incapacitates the federal government, Republican leaders in dozens of state capitols are passing laws to undermine health and safety regulations, ban abortion, limit LGBT+ rights, and implement more conservative policies on voting, school curriculums, and climate policy. To understand the implications for population health, researchers must break with custom; although scientific literature has traditionally avoided discussing politics, the growing influence of partisan affiliation on policies affecting health makes this covariate an increasingly important subject of study.
What has this to do with so-called alternative medicine (SCAM)?
Not a lot.
Except, of course, that Trump has been quite sympathetic to both quackery and quacks (see, for instance, here and here). Moreover, the embarrassing Dr. Oz, America’s charlatan-in-chief, is now a Republican candidate for the US senate. And the creation of the NHI office for alternative medicine, currently called NCCIH, was the idea of the Republican senator, Tom Harkin.
I think we get the drift: on the US political level, SCAM seems to be a right-wing thing.
Am I claiming that SCAM is the cause of the higher mortality in Republican counties?
Do I feel that both are related to irresponsible attitudes towards healthcare issues?