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

case-control study

1 2 3 7

Muscular dystrophies are a rare, severe, and genetically inherited disorders characterized by progressive loss of muscle fibers, leading to muscle weakness. The current treatment includes the use of steroids to slow muscle deterioration by dampening the inflammatory response. Chinese herbal medicine (CHM) has been offered as adjunctive therapy in Taiwan’s medical healthcare plan, making it possible to track CHM usage in patients with muscular dystrophies. This investigation explored the long-term effects of CHM use on the overall mortality of patients with muscular dystrophies.

A total of 581 patients with muscular dystrophies were identified from the database of Registry for Catastrophic Illness Patients in Taiwan. Among them, 80 and 201 patients were CHM users and non-CHM users, respectively. Compared to non-CHM users, there were more female patients, more comorbidities, including chronic pulmonary disease and peptic ulcer disease in the CHM user group. After adjusting for age, sex, use of CHM, and comorbidities, patients with prednisolone usage exhibited a lower risk of overall mortality than those who did not use prednisolone. CHM users showed a lower risk of overall mortality after adjusting for age, sex, prednisolone use, and comorbidities. The cumulative incidence of the overall survival was significantly higher in CHM users. One main CHM cluster was commonly used to treat patients with muscular dystrophies; it included Yin-Qiao-San, Ban-Xia-Bai-Zhu-Tian-Ma-Tang, Zhi-Ke (Citrus aurantium L.), Yu-Xing-Cao (Houttuynia cordata Thunb.), Che-Qian-Zi (Plantago asiatica L.), and Da-Huang (Rheum palmatum L.).

The authors concluded that the data suggest that adjunctive therapy with CHM may help to reduce the overall mortality among patients with muscular dystrophies. The identification of the CHM cluster allows us to narrow down the key active compounds and may enable future therapeutic developments and clinical trial designs to improve overall survival in these patients.

I disagree!

What the authors have shown is a CORRELATION, and from that, they draw conclusions implying CAUSATION. This is such a fundamental error that one has to wonder why a respected journal let it go past.

A likely causative explanation of the findings is that the CHM group of patients differed in respect to features that the statistical evaluations could not control for. Statisticians can never control for factors that have not been measured and are thus unknown. A possibility in the present case is that these patients had adopted a different lifestyle together with employing CHM which, in turn, resulted in a longer survival.

As discussed regularly on this blog, there is plenty of evidence to show that many chiropractors, homeopaths, and naturopaths discourage their patients from getting vaccinated. Now, a further investigation from the US seems to confirm these findings.

This analysis aims to evaluate differences between categories of so-called alternative medicine (SCAM) regarding vaccination behavior among US adults.

The data from the 2017 National Health Interview Survey (NHIS; n = 26,742; response rate 80.7%) was used for this purpose. Prevalences of flu vaccination, consultations with SCAM practitioners in the past 12 months, and their potential interactions were examined.

A total of 42.7% of participants had received the flu vaccination in the past 12 months, 32.4% had seen one or more SCAM practitioners. Users of any type of SCAM were as likely as non-users to have received a flu vaccination (44.8% users versus 41.7% non-users; p = 0,862; adjusted odds ratio [AOR] = 1.01, 95% confidence interval [CI] = 0.95-1.07).

Regarding specific SCAMs, individuals consulting with

  • naturopaths (p < 0.001; AOR = 0.67, 95 %CI = 0.54-0.82),
  • homeopaths (p < 0.001; AOR = 0.55; 95 %CI = 0.44-0.69),
  • chiropractors (p = 0.016; AOR = 0.9, 95 %CI = 0.83-0.98)

were less likely, while other SCAM approaches showed no significant association with flu vaccination behavior. Independent predictors for a flu shot were prior diabetes, cancer, current asthma, kidney disease, overweight and current pregnancy. As well, higher educational level, age, ethnicity, health insurance coverage, and having seen a general physician or medical specialist in the past 12 months were also associated with a higher vaccination rate.

The authors concluded that SCAM users were equally likely to receive an influenza vaccination compared with non-users. Different complementary therapies showed varied associations with vaccination behavior. Further analyses may be needed to distinguish influencing factors among patients’ vaccination behavior.

This investigation confirms the prevalent anti-vax stance within chiropractic, homeopathy, and naturopathy. The effect is strongest by far with homeopaths. Nothing new! We knew this for a very long time. The question is WHAT ARE WE DOING ABOUT IT? Or more specifically, are the professional organizations of these SCAM professions finally going to take any actions against even the most rabid anti-vaxxers in their midst?

And the answer?

You guessed it: NO!

And the irony of all this must not get lost here: chiropractors, homeopaths, naturopaths, and their respective organizations all pride themselves regularly that they attribute particular importance to disease prevention.

Germany seems to have a significant problem with anti-vaxxers. Today, only 68% of the population has had a COVID vaccination. In the UK and France, these figures are 72% and 75% respectively.

How come?

This study investigated the willingness to vaccinate of parents of minors and people without children who are minors. The investigation was based on a random sample of Germans (telephone survey, n = 2,014, collected between 12 November and 10 December 2020). The evaluation is primarily based on the sub-sample of people with minors in the household (n = 461).

Parents of minors consistently show a lower willingness to be vaccinated with a COVID-19 vaccine than respondents without minors (54.1% vs 71.1%). Fathers show a stronger willingness to be vaccinated than mothers. Furthermore, men are more willing to get their own child vaccinated with a COVID-19 vaccine than are women.

The authors concluded that among parents and especially mothers, a considerable misrepresentation of vaccination risks and frequent beliefs in vaccination conspiracy theories can be observed. Clear and easily understandable information on the effects and side effects of vaccination with a COVID-19 vaccine by relevant institutions and physicians is recommended.

And what has this to do with so-called alternative medicine (SCAM) and homeopathy?

In the results section of the paper, the authors report interesting  additional findings (my translation):

In the total sample, a significantly higher willingness to vaccinate is associated with the rejection of “alternative healing methods”. There is also a significant correlation between the attitude towards homeopathy and one’s own willingness to vaccinate: if homeopathy is supported, the willingness to vaccinate is lower. This correlation between the attitude towards homeopathy and willingness to vaccinate is also evident in the sub-sample of parents. Among parents, it is again women who significantly more often have a positive attitude towards homeopathy than men, who more often do not think anything of it.

The authors also report that the parents were asked: “If a vaccine against the coronavirus is approved in Germany, would you get vaccinated?” CERTAINLY NOT was the answer of:

  • 41% of homeopathy fans
  • 10% of people who thought nothing at all about homeopathy
  • 15% of participants who were not fully convinced by homeopathy

Yes, Germany seems to have a problem with the anti-vaccination brigade but it seems that at the heart of it is a problem with a homeopathy cult.

 

I was alerted to an interesting article about homeopathy in Switzerland. Its author points out that homeopathy is paid for by health insurance in Switzerland because of anything remotely related to evidence but because of a referendum in 2009. At the time, one of the arguments of the proponents was that health care costs would tend to decrease if more so-called alternative medicine (SCAM) would be paid for by the public purse. This is what Jacques de Haller, the president of the medical association, claimed: because SCAM is comparatively cheap and helps to prevent more expensive consultations, the total cost of health care would decrease.

This rather naive assumption was also one made in 2005 by the ‘Smallwood-Report’, commissioned by Charles and paid for by Dame Shirley Porter, specifically to inform health ministers. It stated that up to 480 million pounds could be saved if one in 10 family doctors offered homeopathy as an alternative to standard drugs. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. (Because I had commented on this report, Prince Charles’ first private secretary asked the vice-chancellor of Exeter University, Steve Smith, to investigate. Even though I was found to be not guilty of any wrongdoing, specifically of violating confidentiality, all local support stopped which led to my decision to retire early.)

In Switzerland, the assumption that SCAM saves money was refuted in 2019 by the Swiss health insurance association Santésuisse in a proper cost analysis. According to this analysis, doctors who also prescribed homeopathy caused 22% more costs per patient than those practicing conventional medicine. As it turned out, SCAM would be charged in addition to existing conventional medical services. Consequently, from a point of view of health economics, SCAM should not be called “alternative”, but rather “additive”, Santésuisse wrote at the time.

More evidence comes from a German study (authored by proponents of homeopathy!) that confirms these findings. Integrated care contracts for homeopathy by German health insurers were shown to result in higher costs across all diagnoses.

The recognition that homeopathy lacks sound evidence has already led to an end of reimbursement in the UK and France. Both in Germany and Switzerland, strong pro-homeopathy lobbies have so far succeeded in preventing similar actions. Yet, there is no doubt that, in these and other countries, the writing is on the wall.

Prior research has generated inconsistent results regarding vaccination rates among patients using so-called alternative medicine (SCAM). Given that SCAM includes a wide range of therapies – about 400 different treatments have been counted – variable vaccination patterns may occur within consultations with different types of SCAM practitioners.

A recent analysis aimed to evaluate differences between categories of SCAM regarding vaccination behavior among US adults.

Data from the 2017 National Health Interview Survey (NHIS; n = 26,742; response rate 80.7%) were used. Prevalences of flu vaccination, consultations with SCAM practitioners in the past 12 months, and their potential interactions were examined. 42.7% of participants had received the flu vaccination in the past 12 months, 32.4% had seen one or more SCAM practitioners. Users of any type of SCAM were as likely as non-users to have received a flu vaccination (44.8% users versus 41.7% non-users; p = 0,862; adjusted odds ratio [AOR] = 1.01, 95% confidence interval [CI] = 0.95–1.07).

Regarding specific SCAM types,

  • individuals consulting with naturopaths (p < 0.001; AOR = 0.67, 95 %CI = 0.54–0.82),
  • homeopaths (p < 0.001; AOR = 0.55; 95 %CI = 0.44–0.69)
  • chiropractors (p = 0.016; AOR = 0.9, 95 %CI = 0.83–0.98)

were less likely to be vaccinated. Other SCAMs showed no significant association with flu vaccination behavior. Independent predictors for a flu shot were prior diabetes, cancer, current asthma, kidney disease, overweight and current pregnancy. As well, higher educational level, age, ethnicity, health insurance coverage, and having seen a general physician or medical specialist in the past 12 months were also associated with a higher vaccination rate.

The authors concluded that SCAM users were equally likely to receive an influenza vaccination compared with non-users. Different SCAM therapies showed varied associations with vaccination behavior. Further analyses may be needed to distinguish influencing factors among patients’ vaccination behavior.

This survey confirms what we have discussed repeatedly on this blog (see, for instance here, here, here, here, and here). The reason why consumers who consult naturopaths, homeopaths, or chiropractors get vaccinated less regularly is presumably that these practitioners tend to advise against vaccinations. And why do they do that?

  • Naturopaths claim that vaccines are toxic and their therapeutic options protect against infections.
  • Homeopaths claim that vaccines are toxic and their therapeutic options protect against infections.
  • Chiropractors claim that vaccines are toxic and their therapeutic options protect against infections.

Do these ‘therapeutic options’ – detox, nosodes, spinal manipulation – have anything in common?

Yes, they are bogus!

Conclusion:

Many naturopaths, homeopaths, and chiropractors seem to be a risk to public health.

This study assessed the effects of being born under the zodiac sign Pisces on mortality. For that purpose, a retrospective observational study was conducted of the data from 26 Scandinavian intensive care units between 2009 and 2011. Patients aged 18 years or older with severe sepsis and in need of fluid resuscitation were included from the Scandinavian Starch for Severe Sepsis/ Septic Shock (6S) trial. The main outcome measure was the 90-day mortality.

The researchers included all 798 patients in the study; 70 (9%) of them were born under the sign of Pisces. The primary outcome (death within 90 days) occurred in 25 patients (35.7%) in the Pisces group, compared with 348 patients (48%) in the non-Pisces group (relative risk, 0.75; 95% CI, 0.54-1.03; one-sided P = 0.03).

The authors concluded that in a multicentre randomised clinical trial of IV fluids, being born under the sign of Pisces was associated with a decreased risk of death. Our study shows that with convenient use of statistics and an enticing explanatory hypothesis, it is possible to achieve significant findings in post-hoc analyses of data from large trials.

This is an excellent paper! It showcases the sort of nonsense one can do with datasets, statistics, and post hoc hypotheses. The authors entitled their article “Gone fishing in a fluid trial”, and this title should ensure that there are not some astrology nutters who mistake correlation for causation

… I hope

… but, of course, I am an optimist.

Vertebral artery dissections (VAD) are a rare but important cause of ischemic stroke, especially in younger patients. Many etiologies have been identified, including motor vehicle accidents, cervical fractures, falls, physical exercise, and, as I have often discussed on this blog, cervical chiropractic manipulation. The goal of this study was to investigate the subgroup of patients who suffered a chiropractor-associated injury and determine how their prognosis compared to other-cause VAD.

The researchers, neurosurgeons from Chicago, conducted a retrospective chart review of 310 patients with vertebral artery dissections who presented at their institution between January 2004 and December 2018. Variables included demographic data, event characteristics, treatment, radiographic outcomes, and clinical outcomes measured using the modified Rankin Scale.

Overall, 34 out of our 310 patients suffered a chiropractor-associated injury. These patients tended to be younger (p = 0.01), female (p = 0.003), and have fewer comorbidities (p = 0.005) compared to patients with other-cause VADs. The characteristics of the injuries were similar, but chiropractor-associated injuries appeared to be milder at discharge and at follow-up. A higher proportion of the chiropractor-associated group had injuries in the 0-2 mRS range at discharge and at 3 months (p = 0.05, p = 0.04) and no patients suffered severe long-term neurologic consequences or death (0% vs. 9.8%, p = 0.05). However, when a multivariate binomial regression was performed, these effects dissipated and the only independent predictor of a worse injury at discharge was the presence of a cervical spine fracture (p < 0.001).

The authors concluded that chiropractor-associated injuries are similar to VADs of other causes, and apparent differences in the severity of the injury are likely due to demographic differences between the two populations.

The authors of the present paper are clear: “chiropractic manipulations are a risk factor for vertebral artery dissections.” This fact is further supported by a host of other investigations. For instance, the Canadian Stroke Consortium found that 28% of strokes following cervical artery dissection were preceded by chiropractic neck manipulation. Dziewas et al. obtained a similar rate in patients with vertebral artery dissections. Many chiropractors are in denial; however, this is merely due to their overt conflicts of interest.

My conclusions from the accumulated evidence are this:

Spinal manipulations of the upper spine should not be routinely used for any condition. Patients who nevertheless insist on having them must be made aware of the risks and give informed consent.

The objective of this systematic review was to examine whether back pain is associated with increased mortality risk and, if so, whether this association varies by age, sex, and back pain severity.

A systematic search of published literature was conducted and English-language prospective cohort studies evaluating the association of back pain with all-cause mortality with follow-up periods >5 years were included. Three reviewers independently screened studies, abstracted data, and appraised risk of bias using the Quality in Prognosis Studies (QUIPS) tool. A random-effects meta-analysis estimated combined odds ratios (OR) and 95% confidence intervals (CI), using the most adjusted model from each study. Potential effect modification by a priori hypothesized factors (age, sex, and back pain severity) was evaluated with meta-regression and stratified estimates.

Eleven studies with a total of 81,337 participants were included. Follow-up periods ranged from 5 to 23 years. The presence of any back pain, compared to none, was not associated with an increase in mortality (OR, 1.06; 95% CI, 0.97 to 1.16). However, back pain was associated with mortality in studies of women (OR, 1.22; 95% CI, 1.02 to 1.46) and among adults with more severe back pain (OR, 1.26; 95% CI, 1.14 to 1.40).

The authors concluded that back pain was associated with a modest increase in all-cause mortality among women and those with more severe back pain.

I bet that back pain is associated with hundreds of things. The question is whether there might be a causal association; could it be that people die earlier BECAUSE of back pain?

Unless someone’s back pain is so unbearable that she commits suicide, I cannot see how the two can be directly linked in a cause/effect relationship. But there could be indirect causal links. For instance, certain cancers can cause both back pain and death. Or someone’s back pain might make him take treatment against a life-threatening condition less seriously and thus hasten his death.

It has also occurred to me that chiropractors might jump on the bandwagon and use the association between back pain and mortality for boosting their business. Something like this:

Back pain is a risk factor for premature death.

Come to us, and we treat your back pain.

This will make you live longer.

Chiropractic prolongs life!

That would, of course, be daft. Firstly, chiropractic is not all that effective for back pain (or anything else). Secondly, getting rid of back pain is unlikely to prolong your life.

Correlation is not causation!

 

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.

Epidemiological studies on the association between coffee intake, arguably a herbal remedy, and cancer risk have yielded inconsistent results. To summarize and appraise the quality of the current evidence, researchers conducted an umbrella review of existing findings from meta-analyses of observational studies.

They searched PubMed, Embase, Web of Science and the Cochrane database to obtain systematic reviews and meta-analyses of associations between coffee intake and cancer incidence. For each association, they estimated the summary effect size using the fixed- and random-effects model, the 95% confidence interval, and the 95% prediction interval. We also assessed heterogeneity, evidence of small-study effects, and excess significance bias.

Twenty-eight individual meta-analyses including 36 summary associations for 26 cancer sites were retrieved for this umbrella review. A total of 17 meta-analyses were significant at P ≤ 0.05 in the random-effects model. For the highest versus lowest categories, 4 of 26 associations had a more stringent P value (P ≤ 10− 6). Associations for five cancers were significant in dose-response analyses. Most studies (69%) showed low heterogeneity (I2 ≤ 50%). Three and six associations had evidence of excessive significance bias and publication bias, respectively. Coffee intake was inversely related to the risk of liver cancer and endometrial cancer and was characterized by dose-response relationships. There were no substantial changes when the researchers restricted analyses to a meta-analysis of cohort studies.

The authors concluded that there is highly suggestive evidence for an inverse association between coffee intake and risk of liver and endometrial cancer. Further research is needed to provide more robust evidence for cancer at other sites.

This is an interesting analysis that begs many questions. Let me just make four brief points:

  1. Correlation is not causation! Epidemiological studies throw up all sorts of associations that are too often mistaken as causal relationships. The question of whether coffee causes a decrease in the risk of certain cancers is as yet unanswered. The authors mention dose relationships which would, of course, increase the likelihood of a causal effect. Yet, they do not prove it.
  2. Another argument that would strengthen the possibility of a causal effect would be a plausible mechanism of action. However, the biological mechanism of how coffee might affect the risk remains unclear. Coffee contains a range of biologically active chemicals, including caffeine and phenolic compounds. In so-called alternative medicine (SCAM), coffee is also claimed to be a ‘detox‘ remedy. Yet it is unclear how exactly they might reduce the risk.
  3. The studies were all about the oral consumption of coffee. None considered anal application, like in Gerson therapy.
  4. The only way to find out whether coffee does, in fact, reduce the risk of certain cancers is to conduct prospective controlled clinical trials. Such studies are, however, not easy to conduct, particularly if designed such that their findings are truly reliable.

So, the answer to the question DOES COFFEE CONSUMPTION PREVENT CANCER? will remain unanswered for some time, I am afraid. Meanwhile, I suggest we enjoy our coffee per oral (and avoid it per anal).

1 2 3 7
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories