MD, PhD, FMedSci, FSB, FRCP, FRCPEd

commercial interests

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We have discussed this notorious problem before: numerous charities (such as one that treats HIV and malaria with homeopathy in Botswana, or the one claiming that homeopathy can reverse cancer) are a clear danger to public health. I have previously chosen the example of ‘YES TO LIFE’ and explained that they promote unproven and disproven alternative therapies as cures for cancer (and if you want to get really sickened, look who act as their supporters and advisors). It is clear to me that such behaviour can hasten the death of many vulnerable patients.

Yet, many such charities get tax and reputational benefits by being registered charities in the UK. The question is CAN THIS SITUATION BE JUSTIFIED?

Currently, the UK Charity commission want to answer it. Specifically, they are asking you the following question:

  • Question 1: What level and nature of evidence should the Commission require to establish the beneficial impact of CAM therapies?
  • Question 2: Can the benefit of the use or promotion of CAM therapies be established by general acceptance or recognition, without the need for further evidence of beneficial impact? If so, what level of recognition, and by whom, should the Commission consider as evidence?
  • Question 3: How should the Commission consider conflicting or inconsistent evidence of beneficial impact regarding CAM therapies?
  • Question 4: How, if at all, should the Commission’s approach be different in respect of CAM organisations which only use or promote therapies which are complementary, rather than alternative, to conventional treatments?
  • Question 5: Is it appropriate to require a lesser degree of evidence of beneficial impact for CAM therapies which are claimed to relieve symptoms rather than to cure or diagnose conditions?
  • Question 6: Do you have any other comments about the Commission’s approach to registering CAM organisations as charities?

I am sure that most readers of this blog have something to say about these questions. So, please carefully study the full document, go on the commission’s website, and email your response to: legalcharitablestatus@charitycommission.gsi.gov.uk . Don’t delay it; do it now!

THANK YOU!

On this blog, we have had (mostly unproductive) discussions with homeopath so often that sometimes they sound like a broken disk. I don’t want to add to this kerfuffle; what I hope to do today is to summarise  a certain line of argument which, from the homeopaths’ point of view, seems entirely logical. I do this in the form of a fictitious conversation between a scientist (S) and a classical homeopath (H). My aim is to make the reader understand homeopaths better so that, future debates might be better informed.

HERE WE GO:

S: I have studied the evidence from studies of homeopathy in some detail, and I have to tell you, it fails to show that homeopathy works.

H: This is not true! We have plenty of evidence to prove that patients get better after seeing a homeopath.

S: Yes, but this is not because of the remedy; it is due to non-specific effect like the empathetic consultation with a homeopath. If one controls for these factors in adequately designed trials, the result usually is negative.

I will re-phrase my claim: the evidence fails to show that highly diluted homeopathic remedies are more effective than placebos.

H: I disagree, there are positive studies as well.

S: Let’s not cherry pick. We must always consider the totality of the reliable evidence. We now have a meta-analysis published by homeopaths that demonstrates the ineffectiveness of homeopathy quite clearly.

H: This is because homeopathy was not used correctly in the primary trials. Homeopathy must be individualised for each unique patient; no two cases are alike! Remember: homeopathy is based on the principle that like cures like!!!

S: Are you saying that all other forms of using homeopathy are wrong?

H: They are certainly not adhering to what Hahnemann told us to do; therefore you cannot take their ineffectiveness as proof that homeopathy does not work.

S: This means that much, if not most of homeopathy as it is used today is to be condemned as fake.

H: I would not go that far, but it is definitely not the real thing; it does not obey the law of similars.

S: Let’s leave this to one side for the moment. If you insist on individualised homeopathy, I must tell you that this approach can also be tested in clinical trials.

H: I know; and there is a meta-analysis which proves that it is effective.

S: Not quite; it concluded that medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

If you call this a proof of efficacy, I would have to disagree with you. The effect was tiny and at least two of the best studies relevant to the subject were left out. If anything, this paper is yet another proof that homeopathy is useless!

H: You simply don’t understand homeopathy enough to say that. I tried to tell you that the remedy must be carefully chosen to fit each unique patient. This is a very difficult task, and sometimes it is not successful – mainly because the homeopaths employed in clinical trials are not skilled enough to find it. This means that, in these studies, we will always have a certain failure rate which, in turn, is responsible for the small average effect size.

S: But these studies are always conducted by experienced homeopaths, and only the very best, most experienced homeopaths were chosen to cooperate in them. Your argument that the trials are negative because of the ineffectiveness of the homeopaths – rather than the ineffectiveness of homeopathy – is therefore nonsense.

H: This is what you say because you don’t understand homeopathy!

S: No, it is what you say because you don’t understand science. How else would you prove that your hypothesis is correct?

H: Simple! Just look at individual cases from the primary studies within this meta-analysis . You will see that there are always patients who did improve. These cases are the proof we need. The method of the RCT is only good for defining average effects; this is not what we should be looking at, and it is certainly not what homeopaths are interested in.

S: Are you saying that the method of the RCT is wrong?

H: It is not always wrong. Some RCTs of homeopathy are positive and do very clearly prove that homeopathy works. These are obviously the studies where homeopathy has been applied correctly. We have to make a meta-analysis of such trials, and you will see that the result turns out to be positive.

S: So, you claim that all the positive studies have used the correct method, while all the negative ones have used homeopathy incorrectly.

H: If you insist to put it like that, yes.

S: I see, you define a trial to have used homeopathy correctly by its result. Essentially you accept science only if it generates the outcome you like.

H: Yes, that sounds odd to you – because you don’t understand enough of homeopathy.

S: No, what you seem to insist on is nothing short of double standards. Or would you accept a drug company claiming: some patients did feel better after taking our new drug, and this is proof that it works?

H: You see, not understanding homeopathy leads to serious errors.

S: I give up.

A new survey from the Frazer Institute, an independent, non-partisan Canadian public policy think-tank, suggests that more and more Canadians are using alternative therapies. In 2016, massage was the most common type of therapy that Canadians used over their lifetime with 44 percent having tried it, followed by chiropractic care (42%), yoga (27%), relaxation techniques (25%), and acupuncture (22%). Nationally, the most rapidly expanding therapies over the past two decades or so (rate of change between 1997 and 2016) were massage, yoga, acupuncture, chiropractic care, osteopathy, and naturopathy. High dose/mega vitamins, herbal therapies, and folk remedies appear to be in declining use over that same time period.

“Alternative treatments are playing an increasingly important role in Canadians’ overall health care, and understanding how all the parts of the health-care system fit together is vital if policymakers are going to find ways to improve it,” said Nadeem Esmail, Fraser Institute senior fellow and co-author of Complementary and Alternative Medicine: Use and Public Attitudes, 1997, 2006 and 2016.

The updated survey of 2,000 Canadians finds more than three-quarters of Canadians — 79 per cent — have used at least one complementary or alternative medicine (CAM) or therapy sometime in their lives. That’s an increase from 74 per cent in 2006 and 73 per cent in 1997, when two previous similar surveys were conducted. In fact, more than one in two Canadians (56 per cent) used at least one complementary or alternative medicine or therapy in the previous 12 months, an increase from 54 per cent in 2006 and 50 per cent in 1997.

And Canadians are using those services more often, averaging 11.1 visits in 2016, compared to fewer than nine visits a year in both 2006 and 1997. In total, Canadians spent $8.8 billion on complementary and alternative medicines and therapies last year, up from $8 billion (inflation adjusted) in 2006.

The majority of respondents — 58 per cent — support paying for alternative treatments privately and don’t want them included in provincial health plans. Support for private payment is even highest (at 69 per cent) among 35- to 44-year-olds. “Complementary and alternative therapies play an increasingly important role in Canadians’ overall health care, but policy makers should not see this as an invitation to expand government coverage — the majority of Canadians believe alternative therapies should be paid for privately,” Esmail said.

This seems to be a good survey, and it offers a host of interesting information. Yet, it also leaves many pertinent questions unanswered. The most important one might be WHY?

Why are so many people trying treatments which clearly are unproven or disproven?

Enthusiasts would obviously say this is because they are useful in some way. I would, however, point out that the true reason might well be that consumers are systematically mislead about the value of alternative therapies, as I have shown on this blog so many times.

Nevertheless, this seems to be a good survey – there are hundreds, if not thousands of surveys in the realm of alternative medicine which are of such deplorable quality that they do not deserve to be published at all – but even with a relatively good survey, we need to be cautious. For instance, I have no difficulty designing a questionnaire that would guarantee a result of 100% prevalence of alternative medicine usage. All I would need to do is to include the following two questions:

  • Have you ever used plant-based products for your well-being or comfort?
  • Have you ever prayed while being ill?

Drinking a cup of tea would already have to prompt a positive reply to the 1st question. And if you answer yes to the 2nd question, it would be interpreted as using prayer as a therapy.

I think, I rest my case.

The question whether spinal manipulative therapy (SMT) is effective for acute low back pain is still discussed controversially. Chiropractors (they use SMT more regularly than other professionals) try everything to make us believe it does work, while the evidence is far less certain. Therefore, it is worth considering the best and most up-to-date data.

The  aim of this paper was to systematically review studies of the effectiveness and harms of SMT for acute (≤6 weeks) low back pain. The research question was straight forward: Is the use of SMT in the management of acute (≤6 weeks) low back pain associated with improvements in pain or function?

A through literature search was conducted to locate all relevant papers. Study quality was assessed using the Cochrane Back and Neck (CBN) Risk of Bias tool. The evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. The main outcome measures were pain (measured by either the 100-mm visual analog scale, 11-point numeric rating scale, or other numeric pain scale), function (measured by the 24-point Roland Morris Disability Questionnaire or Oswestry Disability Index [range, 0-100]), or any harms measured within 6 weeks.

Of 26 eligible RCTs identified, 15 RCTs (1711 patients) provided moderate-quality evidence that SMT has a statistically significant association with improvements in pain (pooled mean improvement in the 100-mm visual analog pain scale, −9.95 [95% CI, −15.6 to −4.3]). Twelve RCTs (1381 patients) produced moderate-quality evidence that SMT has a statistically significant association with improvements in function (pooled mean effect size, −0.39 [95% CI, −0.71 to −0.07]). Heterogeneity was not explained by type of clinician performing SMT, type of manipulation, study quality, or whether SMT was given alone or as part of a package of therapies. No RCT reported any serious adverse event. Minor transient adverse events such as increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.

The authors concluded that among patients with acute low back pain, spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks, with transient minor musculoskeletal harms. However, heterogeneity in study results was large.

This meta-analysis has been celebrated by chiropractors around the world as a triumph for their hallmark therapy, SMT. But there have also been more cautionary voices – not least from the lead author of the paper. Patients undergoing spinal manipulation experienced a decline of 1 point in their pain rating, says Dr. Paul Shekelle, an internist with the West Los Angeles Veterans Affairs Medical Center and the Rand Corporation who headed the study. That’s about the same amount of pain relief as from NSAIDs, over-the-counter nonsteroidal anti-inflammatory medication, such as ibuprofen. The study also found spinal manipulation modestly improved function. On average, patients reported greater ease and comfort engaging in two day-to-day activities — such as finding they could walk more quickly, were having less difficulty turning over in bed or were sleeping more soundly.

It’s not clear exactly how spinal manipulation relieves back pain. But it may reposition the small joints in the spine in a way that causes less pain, according to Dr. Richard Deyo, an internist and professor of evidence-based medicine at the Oregon Health and Science University. Deyo wrote an editorial published along with the study. Another possibility, Deyo says, is that spinal manipulation may restore some material in the disk between the vertebrae, or it may simply relax muscles, which could be important. There may also be mind-body interaction that comes from the “laying of hands” or a trusting relationship between patients and their health care provider, he says.

Deyo notes that there are many possible treatments for lower back pain, including oral medicine, injected medicine, corsets, traction, surgery, acupuncture and massage therapy. But of about 200 treatment options, “no single treatment is clearly superior,” he says.

In another comment by Paul Ingraham the critical tone was much clearer: “Claiming it as a victory is one of the best examples I’ve ever seen of making lemonade out of science lemons! But I can understand the mistake, because the review itself does seem positive at first glance: the benefits of SMT are disingenuously summarized as “statistically significant” in the abstract, with no mention of clinical significance (effect size; see Statistical Significance Abuse). So the abstract sounds like good news to anyone but the most wary readers, while deep in the main text the same results are eventually conceded to be “clinically modest.” But even even that seems excessively generous: personally, I need at least a 2-point improvement in pain on a scale of 10 to consider it a “modest” improvement! This is not a clearly positive review: it shows weak evidence of minor efficacy, based on “significant unexplained heterogeneity” in the results. That is, the results were all over the place — but without any impressive benefits reported by any study — and the mixture can’t be explained by any obvious, measurable factor. This probably means there’s just a lot of noise in the data, too many things that are at least as influential as the treatment itself. Or — more optimistically — it could mean that SMT is “just” disappointingly mediocre on average, but might have more potent benefits in a minority of cases (that no one seems to be able to reliably identify). Far from being good news, this review continues a strong trend (eg Rubinstein 2012) of damning SMT with faint praise, and also adds evidence of backfiring to mix. Although fortunately “no RCT reported any serious adverse event,” it seems that minor harms were legion: “increased pain, muscle stiffness, and headache were reported 50% to 67% of the time in large case series of patients treated with SMT.” That’s a lot of undesirable outcomes. So the average patient has a roughly fifty-fifty chance of up to roughly maybe a 20% improvement… or feeling worse to some unknown degree! That does not sound like a good deal to me. It certainly doesn’t sound like good medicine.”

END OF QUOTE

As I have made clear in many previous posts, I do fully agree with these latter statements and would add just three points:

  1. We know that many of the SMT studies completely neglect reporting adverse effects. Therefore it is hardly surprising that no serious complications were on record. Yet, we know that they do occur with sad regularity.
  2. None of the studies controlled for placebo effects. It is therefore possible – I would say even likely – that a large chunk of the observed benefit is not due to SMT per se but to a placebo response.
  3. It seems more than questionable whether the benefits of SMT outweigh its risks.

CBC news (Canada) reported yesterday that, more than a decade ago, the Manitoba Chiropractic Health Care Commission had been tasked to review the cost effectiveness of chiropractic services. It therefore prepared a report in 2004 for the Manitoba province and the Manitoba Chiropractors Association. Since then, this report has been kept secret. The report makes 37 recommendations, including:

  • Manitoba Health should limit its funding to “chiropractic treatment of acute lower back pain.”
  • Manitoba Health should provide “limited coverage of the treatment of neck pain.” The report called the literature around the efficacy of chiropractic care for neck pain “ambiguous or at best weakly supportive” and noted such treatment carried a “not insignificant safety risk.”
  • Manitoba Health should not fund chiropractic treatment anyone under 18 “as the literature does not unequivocally justify” the “efficacy or safety” of such treatment.

A Manitoba Ombudsman’s Office report from 2012 might shed some light on why the Manitoba Chiropractic Health Care Commission’s report was never made public. Someone had attempted to get a copy of the report, but large parts of it were redacted. “Access to this record was refused on the basis that disclosure would be harmful to a third party’s business interest,” the ombudsman report notes, “and harm the economic or financial interests or negotiating position of a public body.”

The report also challenged claims that chiropractic treatments can be address a wide variety of medical conditions. It stated that there was not enough evidence to conclude chiropractic treatments are effective in treating muscle tension, migraines, HIV, carpal tunnel syndrome, gastrointestinal problems, infertility or cancer, or as a preventive care treatment. It also said there was not enough evidence to conclude chiropractic treatments are effective for children.

The report urged Manitoba Health to establish a monitoring system to keep a closer eye on “the advertising practices of the Manitoba Chiropractors Association and its members to ensure claims regarding treatments are restricted to those for which proof of efficacy and safety exist.” It suggested the government should have regulatory powers over chiropractic ads.

A recent CBC I-Team investigation found Manitoba chiropractors advertising treatment for a wide range of conditions including Alzheimer’s, autism and pediatric services. The commission report contained sharp criticisms of previous reports that suggested funding chiropractic care could save the health-care system money. Dr. Pranlal Manga authored two widely cited reports which claim that by offering publicly funded chiropractic care, provinces can cut health-care costs. “The Manga study on Manitoba must be rejected as a guide to public policy,” the commission report states, “because its assumptions, methodology and costing of recommendations are all deeply flawed.” The reports states, “What limited evidence the Commission has suggests he [Manga] grossly exaggerates possible medical savings.” Dr. Manga did not respond to CBC’s repeated attempts to contact him.

The commission report also made recommendations around the use of X-ray machines by chiropractors. It suggested chiropractors not own and operate X-ray machines “Given the restrictive conditions under which X-rays are advisable, their poor correlation with low-back problems, their apparent limitation as a guide to appropriate treatment …[and] the apparent complete lack of monitoring [of] the use of X-ray by chiropractors.”  Instead, it recommended consulting with radiologists when imaging is deemed necessary. “The Commission is of the view that the public interest, and even chiropractic itself, would be better served if chiropractors had access to radiologists for this service, rather than perform it themselves,” the report said.

All three report authors declined comment. Calls to Dave Chomiak, who was health minister at the time the report was prepared, were not returned. In an email to CBC, Manitoba Chiropractors Association president Perry Taylor said, “I personally have never seen this 13-year-old document and [it] pre-dates my time as President. As such I have no comment on this.” The CBC I-Team offered to go through the report with Taylor but he did not respond.

MY COMMENT:

This report seems to confirm much of what we have discussed repeatedly on this blog: Chiropractic is not nearly as effective and safe as chiropractors try to make us believe. To hide this fact is certainly dishonest and unethical, but it is in some ways understandable: this knowledge would directly threaten the income of most chiropractors.

Yesterday I commented on another post: “the conflict of interest seems obvious: if homeopaths speak the truth, they are out of business. therefore, they are taught untruths from the first day of their training and eventually end up believing them. there is only one solution, as far as I can see: regulators must prevent them from making false claims. if not, this will go on for another 200 years and damage many patients’ health”. In the light of the above report, I will now re-phrase this: the conflict of interest seems obvious: if chiropractors allowed the truth to be known, they would soon be out of business. Therefore, they are taught untruths from the first day of their training and many end up believing them. There is only one solution, as far as I can see: regulators must prevent chiropractors from making false claims. If not, this abuse will go on for another 120 years and damage many patients’ health.

The ‘SOCIETY OF HOMEOPATHS’ (SoH) have published an official complaint they recently filed with the BBC. As it gives an intriguing insight into their mind-set, I could not resist reproducing it here (warts and all):

“Prompted by the interview with Simon Stevens of NHS England on the Today Programme, on 31st March, the Society of Homeopaths deplores the lack of balance in the BBC’s coverage of Homeopathy and urges you to review your approach to coverage of the subject.

During the Today interview, following wide-ranging discussion of issues around the future of the NHS, Sarah Montague suddenly threw in a question about the amount spent on Homeopathy within the NHS, evidently catching Mr Stevens unawares.

The annual budget of the NHS is approximately £110billion.  Of this, £4million per year (0.0036 of the NHS budget) is spent on Homeopathy.  This hardly justifies the unbalanced and hectoring approach from Sarah Montague.

We acknowledge that it is not always possible or necessary to achieve balance on a particular topic within a single programme but the BBC seems to have a consistent line across all of its platforms of opposition to, and disparagement of, Homeopathy.  A recent example is a piece on the Health section of the BBC website in October 2106 by Nick Tiggle which displayed no balance at all and denigrated Homeopathy and Homeopaths with little or no space given to alternative views.

From these and other instances, it seems clear that the BBC has a biased attitude towards Homeopathy, which may be the result of relying too heavily on a small number of ‘experts’, who openly and persistently campaign against complementary and alternative medicine. These ‘experts’ operate in a similar way to climate change deniers, referring to a limited range of research, often of poor quality, to support their claims that there is ‘no evidence for homeopathy’.

We look forward to BBC programmes which fulfill its mission to explain and provide balance and coverage of the positive effects of Homeopathy.

Mark Taylor Chief Executive Society of Homeopaths”

END OF QUOTE

This hardly needs a comment – perhaps just 6 short points:

  • To the best of my knowledge, the BBC has a policy of not being seen to be biased. The discussion referred to above was about the NHS stopping to pay for treatments that are either not effective (e. g. cough syrups) or cheaper to buy OTC than on prescription (e. g. paracetamol). Homeopathy is both. Therefore it would have even been biased NOT to bring homeopathy into the discussion.
  • To claim the BBC-interviewer caught Stevens off guard is just silly: when you go on the radio to discuss such issues, homeopathy MUST be on your mind.
  • To claim that the BBC is generally biased against homeopathy (on the basis of two anecdotes) is equally silly. The SoH should have done some systematic research on this – perhaps they did and found it failed to support their point? – this would have shown that there is plenty of (far too much) pro-homeopathy stuff on the BBC.
  • To say or imply that homeopathy is of debatable or even no value to the NHS does not disclose bias; on the contrary, it is a reflection of the scientific truth which the BBC has an obligation to report.
  • With their complaint, the SoH disclose an embarrassing degree of naivety and an alarming detachment from reality.
  • Whichever way a rational observer might look at this, the BBC should in future become a much more outspoken defender of the scientific truth – on homeopathy and everything else!!!

The recent meta-analysis by Mathie et al for non-individualised homeopathy (recently discussed here) identified just 3 RCTs that were rated as  ‘reliable evidence’. But just how rigorous are these ‘best’ studies? Let’s find out!

THE FIRST STUDY

The objective of the first trial was “to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women.” Its design was that of a multicentre (35 centres in France), randomized, double-blind, placebo-controlled. One hundred and eight menopausal women, ≥50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥5 hot flashes per day with a significant negative effect on the women’s professional and/or personal life. Treatment was either BRN-01 tablets, a registered homeopathic medicine [not registered in the UK] containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards [available OTC in France]. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrolment and was continued for 12 weeks. The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01. The authors concluded that BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication.

Laboratoires Boiron provided BRN-01, its matching placebo, and financial support for the study. Randomization and allocation were carried out centrally by Laboratoires Boiron. I would argue that the treatment time in this study was way too short for generating a therapeutic response. The evolution of the HFS in the two groups was assessed by analysis of the area under the curve (AUC) of the mean scores recorded weekly from each patient in each group over the duration of the study, including those at enrollment (before any treatment). I wonder whether this method was chosen only when the researchers noted that the HFS at the pre-defined time points did not yield a significant result or whether it was pre-determined (elsewhere in the methods section we are told that “The primary evaluation criterion was the effect of BRN-01 on the HFS, compared with placebo. The HFS was defined as the product of the daily frequency and intensity of all hot flashes experienced by the patient, graded by the women from 1 to 4 (1 = mild; 2 = moderate; 3 = strong; 4 = very strong). These data were recorded by the women on a self-administered questionnaire, assisted by a telephone call from a clinical research associate. Data were collected (i) during the first 2 days after enrolment and before any medication had been taken; (ii) then every Tuesday and Wednesday of each week until the 11th week of treatment, inclusive; and (iii) finally, every day of the 12th week of treatment.”). Two of the authors of this paper are employees of Boiron.

THE SECOND STUDY

The second trial was aimed at finding out “whether a well-known and frequently prescribed homeopathic preparation could mitigate post-operative pain.” It was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). The authors concluded that Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.

Traumeel is a mixture of 6 ingredients, 4 of which are in the D2 potency. Thus it neither is administered as a homeopathic remedy (no ‘like cures like’) nor is it highly diluted. In fact, it is not homeopathy at all but belongs to a weird offspring of homeopathy called ‘homotoxicology’ [this is an explanation from my book: Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel.] The HEEL Company (Baden-Baden, Germany) provided funding for the performance and monitoring of this project, supplied the study medication and placebo, and prepared the randomization list. The positive outcome mentioned in the authors’ conclusion refers to a secondary endpoint. I would argue that the authors should not have noted it there and should have made it clear that the trial generated a negative result.

THE THIRD STUDY

Finally, the third of the 3 ‘rigorous’ studies “evaluated the effectiveness of the homeopathic preparation Plumbum Metallicum  (PM) in reducing the blood lead levels of workers exposed to this metal.” The Brazilian researchers recruited 131 workers to this RCT who took PM in the CH15 potency or placebo for 35 days (10 drops twice daily). Thereafter, the percentage of workers whose lead level had fallen by at least 25% did not differ between the groups, both on intention to treat and per protocol analyses. The authors concluded that PM “had no effect in this study in terms of reducing serum lead in workers exposed to lead.”

This study lacks a power calculation, and arguably the period might have been too short to show an effect. The trial was published in the journal HOMEOPATHY which, some might argue, has not the most rigorous of peer-review procedures.

CONCLUDING REMARKS

The third study seems the most rigorous by far, in my view. The other two trials are seriously under-whelming in several respects, primarily because we cannot be sure how much influence the commercial interests of the sponsor had on their findings. I am sure others will spot weaknesses in all three trials that I failed to see.

Mathie et al partly disagree with my assessment when they write in their paper: “We report separately our model validity assessments of these trials, evaluating consequently their overall quality based on a GRADE-like principle of ‘downgrading’ [14]: two trials [23, 25] rated here as reliable evidence were downgraded to ‘low quality’ overall due to the inadequacy of their model validity; the remaining trial with reliable evidence [24] was judged to have adequate model validity. The latter study [24] thus comprises the sole RCT that can be designated ‘high quality’ overall by our approach, a stark finding that reveals further important aspects of the preponderantly low quality of the current body of evidence in non-individualised homeopathy.”

References 23, 24 and 25 are Padilha (the paper on Plumbum Metallicum), Colau (the RCT on menopausal women) and Singer (the Traumeel trial) respectively. This means that – as per Mathie’s assessment – just the Colau study remains as the sole trial with ‘reliable evidence’ for non-individualised homeopathy.

What Mathie et al seem to forget entirely is that none of the 3 RCTs is a trial of homeopathy as defined by treatment according to the ‘like cures like’ principle. The authors of the second study acknowledge this fact by stating: “Homeopathic purists may find fault in the administration of a standardized combination homeopathic formula to all patients, based upon clinical diagnosis – as opposed to the individualized manner dictated by standard homeopathic practice.”

So, which ever way we look upon this evidence, we cannot possibly deny that the evidence for non-individualised homeopathy is rubbish.

D D Palmer was born on March 7, 1845; so, why do chiros celebrate the ‘CHIROPRACTIC AWARENESS WEEK’ from 10 – 16 of April? Perhaps out of sympathy with the homeopaths (many US chiros also use homeopathy) who had their ‘big week’ during the same period? Please tell me, I want to know!

Anyway, the HAW almost ‘drowned’ the CAW – but only almost.

The British Chiropractic Association did its best to make sure we don’t forget the CAW. On their website, we find an article that alerts us to their newest bit of research. Here are some excerpts:

The consumer survey by the British Chiropractic Association (BCA) of more than 2,000 UK adults who currently suffer from back or neck pain, or have done so in the past, found that almost three in five (56%) people experienced pain after using some form of technological device. Despite this, only 27% of people surveyed had limited or stopped using their devices due to concerns for their back or neck health and posture. The research showed people were most likely to experience back or neck pain after using the following technological devices:

•    Laptop computer (35%)
•    Desktop computer (35%)
•    Smart phone (22%)
•    Tablet (20%)
•    Games console (17%)

The age group most likely to experience back or neck pain when using their smart phone were 16-24 year olds, while nearly half (45%) of young adults 25-34 year olds) admitted to experiencing back or neck pain after using a laptop. One in seven (14%) 16-24 year olds attributed their back or neck pain to virtual reality headsets.

As part of Chiropractic Awareness Week (10-16 April) the BCA is calling for technology companies to design devices with posture in mind, to help tech proof our back health. BCA chiropractor Rishi Loatey comments: “We all know how easy it is to remain glued to our smart phone or tablet, messaging friends or scrolling through social media. However, this addiction to technology could be causing changes to posture, which can lead to increased pressure on the muscles, joints and discs in the spine. Technology companies are now starting to issue older phone models which hark back to a time before smart phones enabled people to do everything from check emails and take pictures, to internet banking. Returning to a time of basic functionality, which may see people look to limit the time spent on their phone, can only be good news for our backs. Yet, in an age where people can now track their health and wellbeing using their phone, technology companies should also start looking at ways to make their devices posture friendly from the outset, encouraging us to take time away from our desks and breaks from our scrolling, gaming and messaging.”

END OF QUOTE

So, here we have it: another piece of compelling, cutting edge research by the BCA. They have made us giggle before but rarely have I laughed so heartily about a ‘professional’ organisation confusing so unprofessionally correlation with causation.

Considering the amount of highly public blunders they managed to inflict on the profession in recent years, I have come to the conclusion that the BCA is a cover organisation of BIG PHARMA with the aim of giving chiropractic a bad name!

 

Homeopathic remedies work for animals and therefore they cannot be placebos!!!

This argument is the standard reply of believers in homeopathy (not least of Prince Charles). It shows, I think, two things:

  1. Believers in homeopathy fail to understand the placebo effect.
  2. They are ill-informed or lying about the evidence regarding homeopathy in animals.

As we have explained on this blog over and over again: the evidence for homeopathy in animals is very much like that in humans: it fails to show that highly diluted homeopathic remedies are more than placebos (see, for instance here, here and here). Now a further study confirms this fact.

The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, the researchers also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. They recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. Cows were observed for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. No significant differences were noted in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk.

The authors concluded that the results indicated no additional effect of homeopathic treatment compared with placebo.

The question is HOW MUCH MORE EVIDENCE IS NEEDED BEFORE HOMEOPATHS ABANDON THEIR BOGUS CLAIM?

To honour Hahnemann’s birthday, a National Convention was held yesterday on ‘World Homeopathy Day’ in New Delhi. The theme of the convention is “Enhancing Quality Research in Homeopathy through scientific evidence and rich clinical experiences”. They could have done with this new study of Influenzinum 9C, it seems to me. This is a homeopathic remedy made from the current influenza vaccine. Influenzinum 9C, also known as homeopathic flu nosode. It is claimed to:

  • strengthen the body and increase its resistance to the season’s flu viruses,
  • protect against cold & flu symptoms such as body aches, nausea, chills, fever, headaches, sore throat, coughs, and congestion,
  • enforce the flu vaccine’s action if you have opted for the flu shot,
  • deal with aftereffects of the flu, and
  • alleviate adverse effects of the flu shot.

As these are the claims made by homeopaths (here is but one example of many: “I’ve been using this for over 30 years for my family, and we have never had the flu!”), French researchers have tested whether Influenzinum works. They just published the results of the first study examining the effectiveness of Influenzinum against influenza-like illnesses.

They conducted a retrospective cohort study during winter 2014-2015. After influenza epidemic, a self-assessment questionnaire was offered to patients presenting for a consultation. The primary endpoint was the declaration of an influenza-like illness. The exposed patients (treated by Influenzinum) were matched to two non-exposed patients (untreated) with a propensity score. A conditional logistic model expressed influenza-like illness risk reduction provided by the Influenzinum.

The cohort included 3514 patients recruited from 46 general practitioners. After matching, the treated group (n=2041) and the untreated group (n=482) did not differ on variables collected. Thus Influenzinum preventive therapy did not significantly alter the likelihood of influenza-like illness.

The authors concluded that Influenzinum preventive therapy did not appear effective in preventing influenza-like illness.

This can be no surprise to anyone you knows what ‘C9’ means: it signifies a dilution of 1: 1 000 000 000 000 000 000 (plus 9 times vigorous shaking, of course).

I am sure that some homeopaths will now question whether Influenzinum is truly homeopathic. Is it based on the ‘like cures like’ principle? Before some clever Dick comments ‘THIS SHOWS THAT PROF ERNST HAS NOT GOT A CLUE ABOUT HOMEOPATHY’, please let me point out that it was not I but the homeopaths who insisted in labelling Influenzinum ‘homeopathic’ (see, for instance, here: “Influenzinum Dose is a homoeopathic medicine created by Laboratoire Boiron. Single dose to be consumed in one step. This homoeopathic medicine is generally used as a substitute for the flu vaccine”). AND WHO AM I TO QUESTION THE AUTHORITY OF BOIRON???

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