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

Monthly Archives: July 2022

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:

  1. A causal link between the treatment and the result is highly unlikely.
  2. It is regrettable that researchers do not use randomization for potentially important trials.
  3. It seems unethical to encourage placebo use for the prevention of a serious illness.

_______________________

UPDATE

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.

The purpose of this study was to examine the trends in the expenditure and utilization of chiropractic care in a representative sample of children and adolescents in the United States (US) aged <18 years.

The researchers evaluated serial cross-sectional data (2007-2016) from the Medical Expenditure Panel Survey. Weighted descriptive statistics were conducted to derive national estimates of expenditure and utilization, and linear regression was used to determine trends over time. Sociodemographic and clinical characteristics of chiropractic users were also reported.

A statistically significant increasing trend was observed for the number of children receiving chiropractic care (P <.05) and chiropractic utilization rate (P < .05). Increases in chiropractic expenditure and the number of chiropractic visits were also observed over time but were not statistically significant (P > .05). The mean annual number of visits was 6.4 visits, with a mean expenditure of $71.49 US dollars (USD) per visit and $454.08 USD per child. Children and adolescent chiropractic users in the United States were primarily 14 to 17 years old (39.6%-61.6%), White (71.5%-76.9%), male (50.6%-51.3%), and privately insured (56.7%-60.8%). Chiropractic visits in this population primarily involved low back conditions (52.4%), spinal curvature (14.0%), and head and neck complaints (12.8%).

The authors concluded that the number of children visiting a chiropractor and percent utilization showed a statistically significant, increasing trend from 2007 to 2016; however, total expenditure and the number of chiropractic visits did not significantly differ during this period. These findings provide novel insight into the patterns of chiropractic utilization in this understudied age group.

Why are these numbers increasing?

Is it because of increasing and sound evidence showing that chiropractors do more good than harm to kids?

No!

A recent systematic review of the evidence for effectiveness and harms of specific spinal manipulation therapy (SMT) techniques for infants, and children suggests the opposite.

Its authors searched electronic databases up to December 2017. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1–18 years), were included to determine effectiveness. Controlled and observational studies and case reports were included to examine harms. One author screened titles and abstracts and two authors independently screened the full text of potentially eligible studies for inclusion. Two authors assessed the risk of bias in included studies and the quality of the body of evidence using the GRADE methodology. Data were described according to PRISMA guidelines and CONSORT and TIDieR checklists. If appropriate, a random-effects meta-analysis was performed.

Of the 1,236 identified papers, 26 studies were eligible. In all but 3 studies, the therapists were chiropractors. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication, and treatment comparison were scarce. Due to very low-quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis. Five case reports described severe harms after HVLA manipulations in 4 infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children and could be interpreted as a side effect of treatment.

The authors concluded that, based on GRADE methodology, we found the evidence was of very low quality; this prevented us from drawing conclusions about the effectiveness of specific SMT techniques in infants, children and adolescents. Outcomes in the included studies were mostly parent or patient-reported; studies did not report on intermediate outcomes to assess the effectiveness of SMT techniques in relation to the hypothesized spinal dysfunction. Severe harms were relatively scarce, poorly described and likely to be associated with underlying missed pathology. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique in infants, children and adolescents. We encourage future research to describe effectiveness and safety of specific SMT techniques instead of SMT as a general treatment approach.

But chiros do more than just SMT, I hear some say.

Yes, they do!

But they nevertheless manipulate virtually every patient, and the additional treatments they use are merely borrowed from other disciplines.

So, why are the numbers increasing then?

I suggest this as a main reason:

chiropractors are systematically misleading the public about the value of their trade.

Due to polypharmacy combined with the rising popularity of so-called alternative medicines (SCAM), oncology patients are at particular risk of drug-drug interactions (DDI) or herb-drug interactions (HDI). Caution is therefore indicated.

The aims of this study were to assess DDI and HDI in outpatients taking oral anticancer drugs.

All prescribed and non-prescribed medications, including SCAM, were prospectively collected by hospital pharmacists during a structured interview with the patient. DDI and HDI were analyzed using four interaction software programs: Thériaque®, Drugs.com®, Hédrine, and Memorial Sloan Kettering Cancer Center (MSKCC) database. All detected interactions were characterized by severity, risk, and action mechanism. The need for pharmaceutical intervention to modify drug use was determined on a case-by-case basis.

294 patients were included, with a mean age of 67 years. The median number of chronic drugs per patient was 8 [1-29] and 55% of patients used at least one SCAM. At least 0ne interaction was found for 267 patients (90.8%): 263 (89.4%) with DDI, 68 (23.1%) with HDI, and 64 (21.7%) with both DDI and HDI. Only 13% of the DDI were found in Thériaque® and Drugs.com® databases, and 125 (2.5%) were reported with a similar level of risk on both databases. 104 HDI were identified with only 9.5% of the interactions found in both databases. 103 pharmaceutical interventions were performed, involving 61 patients (20.7%).

The authors concluded that potentially clinically relevant drug interactions were frequently identified in this study, showing that several databases and structured screening are required to detect more interactions and optimize medication safety.

This figure of potential HDIs is high – much higher than in most previous studies. A possible explanation could be that the study was carried out in France where the use of herbal remedies is considerable. As some HDIs can cause serious problems for patients, my advice is to think twice about using herbal remedies while taking prescription drugs. I think this advice is sound regardless of whether someone is suffering from cancer or any other condition.

It has been reported by several outlets that a young woman is fighting for her life after a chiropractic adjustment went horribly wrong. Caitlin Jensen had only recently graduated from University. When she went for what was meant to be a simple chiropractic adjustment on June 16, she suffered four dissected arteries in her neck, this damage led to cardiac arrest, stroke and her being without a pulse for over 10 minutes, requiring resuscitation.

She was rushed to the Memorial Hospital in Savannah, Georgia, where she was operated on. She was then taken to the neuro ICU in a critical condition with a traumatic brain injury. Every day since she’s been fighting. Currently, she is conscious and able to respond to verbal commands by blinking her eyes, as well as wiggling the toes of her left foot. However, most of her body remains paralyzed.

Her mother Darlene has been posting updates about her daughter’s condition on Facebook. On Saturday Darlene shared the latest news on the condition of her daughter. “She gave her best effort to smile today, and it was the most beautiful thing I’ve ever seen,” Darlene said. “She is progressing with her movements on the left side – wiggling and flexing. She can’t lift her arm yet, or turn her head. Her right side is unchanged – still no movement. Her face doesn’t move very much yet, but she can open her eyes widely to show surprise, and the left corner of her mouth tries to smile. Adorable. Still working on the pneumonia. The antiplatelet therapy seems to be going OK. We don’t see any signs of internal bleeding and are praying that it stays that way.”

And the day before, Darlene posted: “Two weeks ago tonight we didn’t know if Caitlin would make it through the night,” Darlene said. “Dire and catastrophic are two of the words that we heard from our ICU team. We knew they didn’t casually throw around words like that. But – she is alive, and every day is a little better. The accomplishments are both small and monumental at the same time. Today, she gave us a thumbs up. We have been working on this, and she got it! She also nodded again today. It helps to see these things because it reassures us that she is working hard to stay with us and recover. Caitlin is strong, disciplined, and well practised in exercising her brain, and I truly believe that her science background and all of her time studying is going to help her in this long journey. “

Studies have found that traumatic cervical artery dissection is one of the leading causes of stroke in patients under the age of 45, and recent chiropractic neck manipulation is among factors that can be associated with risk of vertebral artery dissection.

Following the tragedy, Caitlin’s mother, Darlene, launched a GoFundMe and has raised more than US$20,000 (AU $29,334 or £16,512) for her ongoing medical expenses.

It is clear that these news reports lack important medical details. What is equally clear is the fact that most such cases are never reported in the medical literature and are thus available only in this fragmented form. The reason for this lamentable situation is obvious: there is no post-marketing surveillance system for chiropractic (such a safeguard would be bad for business, of course).

Consequently, chiropractors across the globe continue to be able to say that such reports are unreliable. The medical literature, they are keen to point out, holds only very few case studies of serious risks of chiropractic spinal manipulation. Hence they falsely claim on every possible occasion that their adjustments are safe. The end effect is that many consumers continue to wrongly assume that chiropractic manipulations might be worth a try.

Guest post by Björn Geir

I have tried to find a form or type of quackery that can be confirmed to have died out and is no longer practised. Once I thought I had found one, but it turns out that phrenology is still “a thing” and is being practised by a few eccentrics.

I am almost convinced by now that any quackery or SCAM, as Professor Ernst has proposed to call it, never dies. Once someone has invented a SCAM, it will live on forever, like the proverbial zombie, neither dead nor properly alive and useful. Even bloodletting, the archetypical reject from the practice of medicine, is still being practised in some corners of this world. Google “Wet cupping” or “Hijama” if you don’t believe me.

The world will have to live with health-related scam and swindle but its popularity can and should be suppressed and held to an acceptable low. If truth and science are promoted and SCAM is vigilantly and constantly opposed, then public trust in it can be held back and even reversed as now has been shown in Norway.

My somewhat abridged translation of an article published on June 30th on the Norwegian state broadcasting services website.

————

Norwegians have become much more sceptical towards natural medicine

Fifteen years ago, most Norwegians had faith in natural medicine. Not anymore.

– This is dramatic. A total reversal of opinion, says John Spilling of Ipsos, a company that performs an annual survey of public opinion in Norway. About 3500 people have been interviewed every year since 1985.

The survey, called Norwegian Monitor, has shown that the alternative industry had its heyday in the 80´s and 90´s, at least according to the Norwegian population’s confidence in natural medicine.

On average, eight out of ten thought this kind of therapy and naturopaths could help when ordinary doctors had given up.

But after the turn of the millennium, something started to happen.

The confidence plummeted.

A screenshot from the article showing the representation of the annual Norwegian Monitor survey results for the statement: Naturopaths and natural medicine can often help when ordinary doctors and medicine fall short.

The results are represented as follows:

Black – Impossible to answer
Grey – No answer
Dark red – Totally disagree
Light red – Partially disagree
Dark blue – Partially agree
Light blue – Totally agree

The graph in the article is interactive so you can find the individual rates by hovering over the bars in the article online.

This year only three out of ten fully or partially agree that natural medicine and naturopaths can help. Mr. Spilling is surprised by the magnitude of change, which also has been steadily declining instead of the usual ups and downs seen in so many other areas.

– I see almost no parallels, he says.

The patients stopped coming

The article interviews Ms. Hilde Moldestad. A homeopath since many decades, now retired and leads the Norwegian Homeopathic Patient Association.

Ms. Moldestad marked the decline already while practising.

– The patients stopped coming, because the trends were such that no one was to believe that there was anything good about homeopathy.

She also noted a strongly declining interest within the patient association.

– There are less and less members. People are not so interested in being team members anymore, they want it free online.

Ms. Moldestad is determined that homeopathy works.

– The irony is that the more research that shows that homeopathy works, the stronger the opposition to using the method.

The [Norwegian] National Research Center for Alternative Medicine writes that there is no solid evidence that homeopathic medicines have an effect. And both the Norwegian Medicines Agency and the Norwegian Pharmacists’ Association believe that in practice the pills only contain water and sugar.

– But we are up in a paradigm shift. The damage that has been inflicted on humanity during the period in which school medicine has been allowed to dominate, can no longer be undermined, says Ms. Moldestad in the patient association.The article then interviews Mr. Gunnar Tjomlid, an active Norwegian sceptic who talks about some local background stories of local interest and speculates that perhaps this change correlates with the introduction and distribution of internet access in Norway.

Less use

It is not only the Norwegian Monitor survey that shows a decline for the alternative industry. Every two years, the National Research Center for Alternative Medicine (Nafkam) conducts a survey on, among other things, how often Norwegians visit alternative therapists.

– In 2012, you had just under 40 percent who had been to an alternative therapist. And in December 2020, it was 22 percent. So, there has been a declining trend, says Mr. Ola Lillenes, information director at Nafkam.

At the same time, self-treatment, especially with self-help techniques, has increased.

– Healing and homeopathy are probably among those who have fallen the most through these years.

Education and emotions

Jarle Botnen runs the Bø Institute of Natural Medicine in Telemark. In addition, he is part of the steering group in the association of alternative treatment organizations. Over 1000 therapists are affiliated with this organisation which is named Saborg.

– There is a noticeable decline, that is exactly correct, says Botnen.

He has several theories as to why Norwegians have become more sceptical of natural medicine.

Norwegians have received more education and have less trust in their own feelings.

People are used to simple solutions, such as over-the-counter painkillers. They do not treat the cause of the ailments, which takes more time.

It is difficult to distinguish charlatans from the serious [alternative practitioners]. The industry has also not managed to cooperate well enough, according to Botnen.

The pharmaceutical industry has been lobbying to get more of the market for alternative medicine.

The attitude in the media has changed from being positive to natural medicine to often the opposite.

Small brown glass bottles with homeopathic pills lie in a drawer in a pharmacy.

Sales of homeopathic medicines have declined at the same time as Norwegians have become more sceptical of natural medicine.

– We often hear remarks such as “we trust the authorities”, “the authorities have approved the preparation or treatment”. This is reflected in the consumption of chemical and synthetic medicine, which has increased somewhat formidably during this period, Botnen believes.

John Spilling in Ipsos says it is true that people have great confidence in the public sector. Confidence in hospitals and elderly care has also increased, while the alternative industry has had the opposite development.

– Most of Norway’s population does not trust this type of product. I can only understand that the situation of this industry is very different than in 2001.

End of article————-

These are indeed positive and convincing results. I suspect a similar trend has been happening in most other populations? It would be very interesting to know if a similar trend has been observed elsewhere.

In 2007, we published a systematic review summarizing the efficacy of homeopathic remedies used as a sole or additional therapy in cancer care. We have searched the literature using the databases: Amed (from 1985); CINHAL (from 1982); EMBASE (from 1974); Medline (from 1951); and CAMbase (from 1998). Randomized and non-randomized controlled clinical trials including patients with cancer or past experience of cancer receiving single or combined homeopathic interventions were included. The methodological quality of the trials was assessed by Jadad score. Six studies met our inclusion criteria (five were randomized clinical trials and one was a non-randomized study); but the methodological quality was variable including some high-standard studies. Our analysis of published literature on homeopathy thus found insufficient evidence to support the clinical efficacy of homeopathic therapy in cancer care.

Meanwhile, more trials have emerged, not least a dubious study by Frass et al which is currently under investigation. This means that a new evaluation of the totality of the available evidence might be called for. I am pleased to report that such an assessment has just been published.

In this systematic review, the researchers included clinical studies from 1800 until 2020 to evaluate evidence of the effectiveness of homeopathy on physical and mental conditions in patients during oncological treatment.

In February 2021 a systematic search was conducted searching five electronic databases (Embase, Cochrane, PsychInfo, CINAHL, and Medline) to find studies concerning the use, effectiveness, and potential harm of homeopathy in cancer patients.

From all 1352 search results, 18 studies with 2016 patients were included in this SR. The patients treated with homeopathy were mainly diagnosed with breast cancer. The therapy concepts include single and combination homeopathic remedies (used systemically or as mouth rinses) of various dilutions. Outcomes assessed were the influence on toxicity of cancer treatment (mostly hot flashes and menopausal symptoms), time to drain-removal in breast cancer patients after mastectomy, survival, quality of life, global health and subjective well-being, anxiety, and depression as well as safety and tolerance.

The included studies reported heterogeneous results: some studies described significant differences in quality of life or toxicity of cancer treatment favoring homeopathy, whereas others did not find an effect or reported significant differences to the disadvantage of homeopathy or side effects caused by homeopathy. The majority of the studies have low methodological quality.

The authors concluded that, for homeopathy, there is neither a scientifically based hypothesis of its mode of action nor conclusive evidence from clinical studies in cancer care.

I predict that, if we wait another 15 years, we will have even more studies. I also predict that some of them will be less than reliable or even fake. Finally, I predict that the overall result will still be mixed and unconvincing.

Why can I be so sure?

  1. Because homeopathy lacks biological plausibility as a treatment of cancer (or any other condition).
  2. Because highly diluted homeopathic remedies are pure placebos.
  3. Because homeopathy has developed into a cult where one is no longer surprised to see studies emerging that are too good to be true.
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