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

cost-effectiveness

Guest post by Udo Endruscheit

Switzerland is probably the European country with the strangest complementary and alternative medicine (CAM) regulations in the health insurance system. A total of five different CAM methods have been included in the benefits catalogue of basic insurance for several years. However, this is subject to a strange proviso. How did this come about?

As almost everywhere in Europe, there was a desire in Switzerland in the 1990s to include CAM in the public healthcare system, with homeopathy naturally once again taking pole position. Initially, the urge to include five CAM modalities in basic care was granted, but only provisionally. A major project called the “Complementary Medicine Evaluation Programme” (PEK) was launched in 1999 to evaluate the procedures. Even back then, the criteria of efficacy, appropriateness and cost-effectiveness were prerequisites for reimbursement in health insurance. PEK was intended to create clarity here.

One part of PEK has been the well-known Shang/Egger (2005) study on homeopathy “Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy”, which was to become a bone of contention without precedent. However, this did not change the negative result for homeopathy.

In any case, clear conclusions were drawn in Switzerland not only from this study, but also from the results of the other evaluations: the provisional inclusion of the methods in statutory basic insurance was terminated.

This in turn enraged the supporters of CAM methods, who thought they had already reached their goal with the provisional decision in their favour. Apparently, they had not even considered the possibility that scientific evaluations could actually lead to a sudden end to their wishes, which they believed had already been fulfilled.

In fact, in 2009, the friends of ineffective methods succeeded in bringing about one of the referendums for which Switzerland is known under the catchphrase “direct democracy”. And they prevailed – around two thirds of the votes cast were in favour of CAM and its inclusion in the Swiss Federal Constitution. However, it should be borne in mind that the two-thirds figure is put into perspective if the approval, including the low voter turnout, is converted to the proportion of the total electorate. This leaves just 17 per cent who voted for the CAM. And a closer look at the issue of the constitution also reveals that no unconditional protection space has been created for CAM. This is more or less a kind of good behaviour clause for CAM methods, but not rules that could render laws null and void.

The Swiss government was faced with the question of how to avoid simply ignoring the result of the referendum, while at the same time complying with the still valid requirements for reimbursement in basic insurance. So the representatives of the five CAM directions were actually asked to come to the Federal Office of Public Health with their proof of efficacy and economic efficiency. This was done in 2011.

Of course, this was a little bizarre at this stage – and of course nothing came of it. Or actually it did: once again, no proof could be provided. Meanwhile, a lot of time had passed again and a new Federal Council was forced to take up the matter.

The latter, Alain Berset, came up with the plan that the necessary proof of efficacy could actually be postponed until after the methods had been included in the catalogue of basic insurance benefits. In other words, he gave the methods a governmental leap of faith (which, in view of the long-year history of the case, meant closing several eyes) and postulated that this should be the matter until someone applied for an evaluation of one of the methods.

This is what happened in the year of our Lord 2017. Apparently everyone was able to make their peace with it, which is hardly surprising after ten years of moving around and around. Only the umbrella organisation of health insurers, Santesuisse, grumbled about it and predicted that the announced cost neutrality of such a measure could hardly be expected. Which Santesuisse did indeed prove in a dossier two years later.

The exhausted Swiss have so far left it at that. Homeopathy remained untouched. This was also unfortunate for the reason that the fairy tale of the clever and innovative Switzerland, which knew how important the wishes and preferences of its patients were, was propagated in Germany. The rather strange result of more than ten years of struggle was even passed around by German homeopaths under the name “Swiss model”. Even the leading Swiss press was embarrassed by this and published a clarifying article. And unfortunately, the Swiss began to get used to the existence of hocus-pocus in their basic insurance and to take it for granted.

Until now. Even in Switzerland, the fact that homeopathy is coming under increasing criticism everywhere has probably not gone unnoticed. And the Swiss are actually a rather critical and resistant people. And so it happened that a single brave inhabitant of the country recently decided to exercise his right to demand a new evaluation of homeopathy. The Federal Office of Public Health must have been surprised – or perhaps they were desperately waiting for it? Perhaps. In any case, the application was accepted without hesitation. Meanwhile, a notification has been issued that the hearing procedure for the evaluation has been initiated. The representatives of homeopathy (the service providers), the representatives of the Swiss medical profession and the representatives of the health insurance companies – the aforementioned Santesuisse – will be heard. The final decision will then be made by the Swiss government’s Department of Home Affairs.

How many attempts at an evaluation has this actually been – the third? The fourth? We can’t keep up … We have seen the consequences of scientific questions being decided by majorities. It is to be hoped that Switzerland will not add another chapter to the drama that has been going on since 2005. Mr Berset’s successor, who has been in office since the beginning of the year, should only be given a brief reminder: in Switzerland, too, homeopathy has no effect beyond contextual effects. And that is not enough to prove efficacy, appropriateness and cost-effectiveness.

But cheers to the courageous descendant of William Tell, who is about to single-handedly bring down homeopathy in the Swiss healthcare system!

I had the rare pleasure to give an interview for the ‘Frankfurter Allgemeine’. As it was, of course, in German, I took the liberty to translate it for my non-German speaking readers:

You have researched so-called alternative medicine over several decades, including homeopathy. What is your conclusion?

We are talking about far more than 400 methods – to draw one conclusion about all of them
is completely impossible. Except perhaps for this one: if something sounds too good to be true, it probably is.

Does this apply to homeopathy?

Highly diluted homeopathic remedies are popular because they have no side-effects. But there is also no effect. They are touted as a panacea. This is certainly not the case, on the contrary, they are
ineffective. And any therapy that is ineffective and promoted as a panacea is also dangerous.

How do you explain the fact that so many people swear by homeopathy?

There are several reasons for this. In Germany, homeopathy has an unbroken tradition, it was, for instance, promoted by the Nazis and later in the Federal Republic of Germany. It has a reputation for being gentle and effective. It might be gentle, but it is certainly not effective. It is also supported by lobby groups such as the manufacturers. And most people who use it don’t even understand what it actually is.

In any case, the placebo effect helps. What’s so bad about that??

Nothing at all, on the contrary: it is to be advocated. When we talk about placebo effects, we subsume many things under this umbrella that do not actually belong to it, such as the extensive, empathetic conversation that homeopaths often have with their patients. Besides, a common cold goes away whether you treat it or not. If you then use homeopathy, you can easily get the impression that it worked. Every good, empathetic doctor tries to maximize the placebo effect. To put it bluntly: you don’t need a placebo to generate a placebo effect. Patients also benefit from it when I give an effective remedy with empathy. In addition they benefit from the specific effect of my therapy, which should make up the lion’s share of the therapeutic response. If I withhold the most important thing I mistreat my patient.

But there are diseases for which there are no good remedies.

I often hear that argument. But there is practically always something we can do that at least
improves symptoms. Otherwise you should also say that instead of lying and recommending homeopathy – and thinking that, although there is nothing in it and it doesn’t work, but the patient, being an idiot, should take it nevertheless. It is unethical to use placebos as much as it is to use homeopathy.

Neurophysiologically, the placebo effect is becoming better and better understood.

The Italian neuroscientist Fabrizio Benedetti in particular has done very good work.  But he also warns that this does not justify the use of homeopathy, for example.

Are there any studies on whether the placebo effect of homeopathy with its esoteric superstructure is greater than that giving just a piece of sugar?

There are analyses of what makes a particularly effective placebo. From this, we can learn that effective therapies in evidence-based medicine must be applied with empathy and sufficient time in order to maximize the ever-present placebo effect. So-called alternative medicine often does this quite well, and we can learn something from it. But the reason is that it often has nothing else. Homeopaths are a serious danger because they see homeopathy as a panacea. If someone has homeopathically treated their cold “successfully” for years and then gets cancer, they might think of turning to homeopathy for their cancer. It sounds crazy, but many homeopaths do offer cancer treatments on the internet, for instance. That sends shivers down my spine.

How should doctors and pharmacists react to the demand for homeopathic remedies?

Pharmacists are not primarily salespeople, they are a medical profession – they have to adhere to ethical guidelines. In this respect, evidence-based information of their clients/patients is very important.

Thomas Benkert, President of the German Federal Chamber of Pharmacists, has stated that he would not be able to stop giving advice if he always had to explain the lack of proof of efficacy.

He should perhaps read up on what his ethical duty to patients is.

What if doctors or pharmacists themselves believe in the effect?

Belief should not play a role, but evidence should.

Are you pleased with Lauterbach’s plan to no longer reimburse homeopathy?

I think it’s a shame that he justifies it by saying it’s ineffective. That is true. But the justification should be that it’s esoteric nonsense and therefore ineffective – and dangerous.

In the end, the Bundestag will decide.

I think Lauterbach has a good chance because things have started to move. Medical associations in Germany have spoken out against the additional designation of homeopathy, for example, and overall the wind has changed considerably.

What is it like in the UK, where you live?

The UK healthcare system, NHS, said goodbye to reimbursement of homeopathy about five years ago, even before France. The pharmacists’ association has distanced itself very clearly from homeopathy. However, most pharmacists still sell the remedies and many continue to support them.

You have also had disputes with the current head of state, King Charles. How did that come about?

A few years ago, he commissioned a paper claiming that so-called alternative medicine could save the British health service a lot of money. I protested against this – Charles accused me of leaking it to The Times before it was published. My university launched an investigation, which eventually found me innocent, but it led to the demise of my department. That caused me to retire two years early.

So Charles managed to close down the only research unit in the world that conducted critical and systematic research into so-called alternative medicine. Most researchers in this field only want to confirm their own prejudices and not disprove hypotheses. This is a serious misunderstanding of how science works. If someone reports only positive results for their favorite therapy in all conditions, something is wrong.

Some people say that homeopathy should not be researched because nothing positive can come out of it anyway.

There are certainly some SCAMs that are so nonsensical that they should not be researched, as is currently the case with homeopathy. I put it this way because I have researched homeopathy myself and, from my point of view, the situation was not so crystal clear 30 years ago.

Would you say that you have approached the matter with a sufficiently open mind?

No one can be completely unbiased. That’s why it’s important to do science properly, then you minimize bias as much as possible. When I took up my position at Exeter in 1993, I was perhaps somewhat biased towards homeopathy in a positive sense, because I had learned and used it myself, as well as other alternative medicine methods. The fact that the results then turned out to be negative in the vast majority of cases initially depressed me. But I have to live with that.

Every researcher prefers positive results, also because they are easier to publish. It was clear to me that, if I had succeeded in proving homeopathy right, I wouldn’t get one Nobel Prize, but two. Who wouldn’t want that?

(The interview was conducted by Hinnerk Feldwisch-Drentrup.)

Low back pain (LBP) affects almost all of us at some stage. It is so common that it has become one of the most important indications for most forms of so-called alternative medicine (SCAM). In the discussions about the value (or otherwise) of SCAMs for LBP, we sometimes forget that there are many conventional medical options to treat LBP. It is therefore highly relevant to ask how effective they are. This overview aimed to summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non‐specific LBP.

The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non‐specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety.

Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There was high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non‐steroidal anti‐inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub‐acute LBP and five reviews included participants with chronic LBP.

Acute LBP

Paracetamol

There was high‐certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI ‐0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33).

NSAIDs

There was moderate‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD ‐7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.98 to ‐3.61), high‐certainty evidence for a small between‐group difference for reducing disability (MD ‐2.02 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐2.89 to ‐1.15), and very low‐certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18).

Muscle relaxants and benzodiazepines

There was moderate‐certainty evidence for a small between‐group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98).

Opioids

None of the included Cochrane Reviews aimed to identify evidence for acute LBP.

Antidepressants

No evidence was identified by the included reviews for acute LBP.

Chronic LBP

Paracetamol

No evidence was identified by the included reviews for chronic LBP.

NSAIDs

There was low‐certainty evidence for a small between‐group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD ‐6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐10.74 to ‐3.19), reducing disability (MD ‐0.85 on a 0‐24 scale (higher scores indicate worse disability), 95% CI ‐1.30 to ‐0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI ‐0.92 to 1.17), all at intermediate‐term follow‐up (> 3 months and ≤ 12 months postintervention).

Muscle relaxants and benzodiazepines

There was low‐certainty evidence for a small between‐group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low‐certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57).

Opioids

There was high‐certainty evidence for a small between‐group difference favouring tapentadol compared to placebo at reducing pain intensity (MD ‐8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI ‐1.22 to ‐0.38), moderate‐certainty evidence for a small between‐group difference favouring strong opioids for reducing pain intensity (SMD ‐0.43, 95% CI ‐0.52 to ‐0.33), low‐certainty evidence for a medium between‐group difference favouring tramadol for reducing pain intensity (SMD ‐0.55, 95% CI ‐0.66 to ‐0.44) and very low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing pain intensity (SMD ‐0.41, 95% CI ‐0.57 to ‐0.26).

There was moderate‐certainty evidence for a small between‐group difference favouring strong opioids compared to placebo for reducing disability (SMD ‐0.26, 95% CI ‐0.37 to ‐0.15), moderate‐certainty evidence for a small between‐group difference favouring tramadol for reducing disability (SMD ‐0.18, 95% CI ‐0.29 to ‐0.07), and low‐certainty evidence for a small between‐group difference favouring buprenorphine for reducing disability (SMD ‐0.14, 95% CI ‐0.53 to ‐0.25).

There was low‐certainty evidence for a small between‐group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11).

Antidepressants

There was low‐certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD ‐0.04, 95% CI ‐0.25 to 0.17) and reducing disability (SMD ‐0.06, 95% CI ‐0.40 to 0.29).

The authors concluded as follows: we found no high‐ or moderate‐certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate‐certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high‐certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low‐ and high‐certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate‐certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low‐certainty evidence that NSAIDs and very low‐ to high‐certainty evidence that opioids may provide a small effect on pain. For safety, we found low‐certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low‐certainty evidence that opioids may increase the risk of adverse events.

This is an important overview, in my opinion. It confirms what I and others have been stating for decades: WE CURRENTLY HAVE NO IDEAL SOLUTION TO LBP.

This is regrettable but true. It begs the question of what one should recommend to LBP sufferers. Here too, I have to repeat myself: (apart from staying as active as possible) the optimal therapy is the one that has the most favourable risk/benefit profile (and does not cost a fortune). And this option is not drugs, chiropractic, osteopathy, acupuncture, or any other SCAM – it is (physio)therapeutic exercise which is cheap, safe, and (mildly) effective.

Advocates of so-called alternative medicine (SCAM) often sound like a broken record to me. They bring up the same ‘arguments’ over and over again, no matter whether they happen to be defending acupuncture, energy healing, homeopathy, or any other form of SCAM. Here are some of the most popular of these generic ‘arguments’:

1. It helped me
The supporters of SCAM regularly cite their own good experiences with their particular form of treatment and think that this is proof enough. However, they forget that any symptomatic improvement they may have felt can be the result of several factors that are unrelated to the SCAM in question. To mention just a few:

  • Placebo
  • Regression towards the mean
  • Natural history of the disease

2. My SCAM is without risk
Since homeopathic remedies, for instance, are highly diluted, it makes sense to assume that they cannot cause side effects. Several other forms of SCAM are equally unlikely to cause adverse effects. So, the notion is seemingly correct. However, this ‘argument’ ignores the fact that it is not the therapy itself that can pose a risk, but the SCAM practitioner. For example, it is well documented – and, on this blog, we have discussed it often – that many of them advise against vaccination, which can undoubtedly cause serious harm.

3. SCAM has stood the test of time
It is true that many SCAMs have survived for hundreds or even thousands of years. It is also true that millions still use it even today. This, according to enthusiasts, is sufficient proof of SCAM’s efficacy. But they forget that many therapies have survived for centuries, only to be proved useless in the end. Just think of bloodletting or mercury preparations from past times.

4 The evidence is not nearly as negative as skeptics pretend
Yes, there are plenty of positive studies on some SCAMs This is not surprising. Firstly, from a purely statistical point of view, if we have, for instance, 1 000 studies of a particular SCAM, it is to be expected that, at the 5% level of statistical significance, about 50 of them will produce a significantly positive result. Secondly, this number becomes considerably larger if we factor in the fact that most of the studies are methodologically poor and were conducted by SCAM enthusiasts with a corresponding bias (see my ALTERNATIVE MEDICINE HALL OF FAME on this blog). However, if we base our judgment on the totality of the most robust studies, the bottom line is almost invariably that there is no overall convincingly positive result.

5. The pharmaceutical industry is suppressing SCAM
SCAM is said to be so amazingly effective that the pharmaceutical industry would simply go bust if this fact became common knowledge. Therefore Big Pharma is using its considerable resources to destroy SCAM. This argument is fallacious because:

  1. there is no evidence to support it,
  2. far from opposing SCAM, the pharmaceutical industry is heavily involved in SCAM (for example, by manufacturing homeopathic remedies, dietary supplements, etc.)

6 SCAM could save a lot of money
It is true that SCAMs are on average much cheaper than conventional medicines. However, one must also bear in mind that price alone can never be the decisive factor. We also need to consider other issues such as the risk/benefit balance. And a reduction in healthcare costs can never be achieved by ineffective therapies. Without effectiveness, there can be no cost-effectiveness.

7 Many conventional medicines are also not evidence-based
Sure, there are some treatments in conventional medicine that are not solidly supported by evidence. So why do we insist on solid evidence for SCAM? The answer is simple: in all areas of healthcare, intensive work is going on aimed at filling the gaps and improving the situation. As soon as a significant deficit is identified, studies are initiated to establish a reliable basis. Depending on the results, appropriate measures are eventually taken. In the case of negative findings, the appropriate measure is to exclude treatments from routine healthcare, regardless of whether the treatment in question is conventional or alternative. In other words, this is work in progress. SCAM enthusiasts should ask themselves how many treatments they have discarded so far. The answer, I think, is zero.

8 SCAM cannot be forced into the straitjacket of a clinical trial
This ‘argument’ surprisingly popular. It supposes that SCAM is so individualized, holistic, subtle, etc., that it defies science. The ‘argument’ is false, and SCAM advocates know it, not least because they regularly and enthusiastically cite those scientific papers that seemingly support their pet therapy.

9 SCAM is holistic
This may or may not be true, but the claim of holism is not a monopoly of SCAM. All good medicine is holistic, and in order to care for our patients holistically, we certainly do not need SCAM.

1o SCAM complements conventional medicine
This argument might be true: SCAM is often used as an adjunct to conventional treatments. Yet, there is no good reason why a complementary treatment should not be shown to be worth the effort and expense to add it to another therapy. If, for instance, you pay for an upgrade on a flight, you also want to make sure that it is worth the extra expenditure.

11 In Switzerland it works, too
That’s right, in Switzerland, a small range of SCAMs was included in basic health care by referendum. However, it has been reported that the consequences of this decision are far from positive. It brought no discernible benefit and only caused very considerable costs.

I am sure there are many more such ‘arguments’. Feel free to post your favorites!

My point here is this:

the ‘arguments’ used in defense of SCAM are not truly arguments; they are fallacies, misunderstandings, and sometimes even outright lies. 

 

This study describes the use of so-called alternative medicine (SCAM) among older adults who report being hampered in daily activities due to musculoskeletal pain. The characteristics of older adults with debilitating musculoskeletal pain who report SCAM use is also examined. For this purpose, the cross-sectional European Social Survey Round 7 from 21 countries was employed. It examined participants aged 55 years and older, who reported musculoskeletal pain that hampered daily activities in the past 12 months.

Of the 4950 older adult participants, the majority (63.5%) were from the West of Europe, reported secondary education or less (78.2%), and reported at least one other health-related problem (74.6%). In total, 1657 (33.5%) reported using at least one SCAM treatment in the previous year.

The most commonly used SCAMs were:

  • manual body-based therapies (MBBTs) including massage therapy (17.9%),
  • osteopathy (7.0%),
  • homeopathy (6.5%)
  • herbal treatments (5.3%).

SCAM use was positively associated with:

  • younger age,
  • physiotherapy use,
  • female gender,
  • higher levels of education,
  • being in employment,
  • living in West Europe,
  • multiple health problems.

(Many years ago, I have summarized the most consistent determinants of SCAM use with the acronym ‘FAME‘ [female, affluent, middle-aged, educated])

The authors concluded that a third of older Europeans with musculoskeletal pain report SCAM use in the previous 12 months. Certain subgroups with higher rates of SCAM use could be identified. Clinicians should comprehensively and routinely assess SCAM use among older adults with musculoskeletal pain.

I often mutter about the plethora of SCAM surveys that report nothing meaningful. This one is better than most. Yet, much of what it shows has been demonstrated before.

I think what this survey confirms foremost is the fact that the popularity of a particular SCAM and the evidence that it is effective are two factors that are largely unrelated. In my view, this means that more, much more, needs to be done to inform the public responsibly. This would entail making it much clearer:

  • which forms of SCAM are effective for which condition or symptom,
  • which are not effective,
  • which are dangerous,
  • and which treatment (SCAM or conventional) has the best risk/benefit balance.

Such information could help prevent unnecessary suffering (the use of ineffective SCAMs must inevitably lead to fewer symptoms being optimally treated) as well as reduce the evidently huge waste of money spent on useless SCAMs.

My second entry into this competition is so special that I will show you its complete, unadulterated abstract. Here it is:

Objective

To compare the safety differences between Chinese medicine (CM) and Western medicine (WM) based on Chinese Spontaneous Reporting Database (CSRD).

Methods

Reports of adverse events (AEs) caused by CM and WM in the CSRD between 2010 and 2011 were selected. The following assessment indicators were constructed: the proportion of serious AEs (PSE), the average number of AEs (ANA), and the coverage rate of AEs (CRA). Further comparisons were also conducted, including the drugs with the most reported serious AEs, the AEs with the biggest report number, and the 5 serious AEs of interest (including death, anaphylactic shock, coma, dyspnea and abnormal liver function).

Results

The PSE, ANA and CRA of WM were 1.09, 8.23 and 2.35 times higher than those of CM, respectively. The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM. The AEs with the most reports were rash, pruritus, nausea, dizziness and vomiting for both CM and WM. The proportions of CM and WM in anaphylactic shock and coma were similar. For abnormal liver function and death, the proportions of WM were 5.47 and 3.00 times higher than those of CM, respectively.

Conclusion

Based on CSRD, CM was safer than WM at the average level from the perspective of adverse drug reactions.

__________________

Perhaps there will be readers who do not quite understand why I find this paper laughable. Let me try to answer their question by suggesting a few other research subjects of similar farcicality.

  • A comparison of the safety of vitamins and chemotherapy.
  • A study of the relative safety of homeopathic remedies and antibiotics.
  • An investigation into the risks of sky diving in comparison with pullover knitting.
  • A study of the pain caused by an acupuncture needle compared to molar extraction.

In case my point is still not clear: comparing the safety of one intervention to one that is fundamentally different in terms of its nature and efficacy does simply make no sense. If one wanted to conduct such an investigation, it would only be meaningful, if one would consider the risk-benefit balance of both treatments.

The fact that this is not done here discloses the above paper as an embarrassing attempt at promoting Traditional Chinese Medicine.

 

PS

In case you wonder about the affiliations of the authors and their support:

  1. School of Management, Nanjing University of Posts and Telecommunications, Nanjing, 210003, China
    Jian-xiang Wei
  2. School of Internet of Things, Nanjing University of Posts and Telecommunications, Nanjing, 210003, China
    Zhi-qiang Lu, Guan-zhong Feng & Yun-xia Zhu

The review was supported by the Major Project of Philosophy and Social Science Research in Jiangsu Universities and the Postgraduate Research & Practice Innovation Program of Jiangsu Province, China.

So-called alternative medicine (SCAM) use has been increasingly prevalent among Americans, whereas its relationship with medical non-adherence is unknown. Using the National Health Interview Survey, this analysis evaluated the use of SCAM modalities and their association with cost-related nonadherence to medical care (CRN) among older Americans by gender strata.

Americans, aged 50 or above in the 2012 National Health Interview Survey, were included to evaluate the use of SCAM modalities and their association with CRN. SCAM modalities were categorized as the use of the following in the past 12 months:

  • 1) herbal supplements;
  • 2) chiropractic or osteopathic manipulations;
  • 3) massage;
  • 4) Yoga, tai chi, or qigong;
  • 5) Mantra/mindfulness/spiritual meditation,
  • 6) acupuncture;
  • 7) mind-body therapy;
  • 8) other SCAM modalities including homeopathy, naturopathy, traditional healers, energy healing therapy, biofeedback, hypnosis, and craniosacral therapy.

CRN was defined as needing medical care but not receiving it due to costs and/or having medical care delayed due to costs in the past 12 months. The investigators developed a multivariable logit model to assess the association of the use of SCAM modalities and CRN controlling for patients age, gender, race, ethnicity, insurance status (Medicare, Medicaid, VA/Tri-care, no-insurance, or private insurance), and comorbid conditions (diabetes, arthritis, back and neck problems, heart condition, stroke, lung and breathing problems, and cancer).

A total of 16,360 older Americans were included in the analysis, with 11,278 (68.9%) reporting at least one SCAM modality use, and 1,992 (12.2%) of them reported CRN. Among the 8 SCAM modalities, compared to those not using SCAM, those who used chiropractic were 94% more likely (p=0.01), those who used Mantra/mindfulness/spiritual meditation were 106% more likely (p<0.01), and those using other modalities were 42% more likely (p=0.07) to report CRN. In contrast, those who used mind-body therapy were 43% less likely (p=0.04) to report CRN. The other 4 modalities did not achieve statistically significant levels although the odds ratios were mostly greater than 1.

The authors argue that the differential association between the SCAM modality use and CRN suggested a complex relationship between the utilization of SCAM and patients’ non-adherence to medical care. It is possible that the out-of-pocket payments for those services significantly increased patients’ cost burden and thus made the use of other medical care unaffordable, and it’s also possible that those who already had low resources were more likely to seek SCAM to substitute for more expensive conventional care. Either of these scenarios would present a serious challenge.

The authors concluded that both men and women are more likely to report financial distress while using various SCAM modalities.

These findings are not easy to interpret. To me, they suggest that, in the US, many consumers have been persuaded to prioritize SCAM over conventional medicine, even if they can ill afford it. It throws a dim light on the US society where some folks seem to struggle to pay for what is essential while continuing to afford the superfluous.

In my view, in a just and non-decadent society, conventional healthcare must be free for everyone at the point of delivery, and SCAM is at best an extra that those who want it should pay out of their own pocket.

I have repeatedly reported about what has been happening with homeopathy in France. For many decades, it had a free ride. Things began to change some 10 years ago.

  • In 2014, our book was published in French. I might be fooling myself, but I do hope that it helped to start a ball rolling.
  • Subsequently, French skeptics began raising their voices against quackery in general and homeopathy in particular.
  • In 2015, Christian Boiron, boss of Boiron, stated about people opposing homeopathy that “Il y a un Ku Klux Klan contre l’homéopathie” THERE IS A KU KLUX KLAN AGAINST HOMEOPATHY”.
  • In 2018, 124 doctors published an open letter criticizing the use of so-called alternative medicine (SCAM).
  • In the same year, the Collège National des Généralistes Engseignants, the national association for teaching doctors, pointed out that there was no rational justification for the reimbursement of homeopathics nor for the teaching of homeopathy in medical schools, and they stated bluntly that it is necessary to abandon these esoteric methods, which belong in the history books.
  • Also in 2018, the University of Lille announced its decision to stop its course on homeopathy. The faculty of medicine’s dean, Didier Gosset, said: It has to be said that we teach medicine based on proof – we insist on absolute scientific rigor – and it has to be said that homeopathy has not evolved in the same direction, that it is a doctrine that has remained on the margins of the scientific movement, that studies on homeopathy are rare, that they are not very substantial. Continuing to teach it would be to endorse it.
  • In 2019, the French Academies of Medicine and Pharmacy published a document entitled ‘L’homéopathie en France : position de l’Académie nationale de médecine et de l’Académie nationale de pharmacie’. It stated that L’homéopathie a été introduite à la fin du XVIIIe siècle, par Samuel Hahnemann, postulant deux hypothèses : celle des similitudes (soigner le mal par le mal) et celle des hautes dilutions. L’état des données scientifiques ne permet de vérifier à ce jour aucune de ces hypothèses. Les méta-analyses rigoureuses n’ont pas permis de démontrer une efficacité des préparations homéopathiques. The academies concluded that no French university should offer degrees in homeopathy, and that homeopathy should no longer be funded by the public purse: “no homeopathic preparation should be reimbursed by Assurance Maladie [France’s health insurance] until the demonstration of sufficient medical benefit has been provided. No university degree in homeopathy should be issued by medical or pharmaceutical faculties … The reimbursing of these products by the social security seems aberrant at a time when, for economic reasons, we are not reimbursing many classic medicines because they are more or less considered to not work well enough …”
  • Only weeks later, the French health regulator (HAS) recommended with a large majority the discontinuation of the reimbursement of homeopathic products.
  • The health minister, Agnès Buzyn, announced “Je me tiendrai à l’avis de la Haute Autorité de santé”.
  • Consequently, the powerful French homeopathy lobby mounted political pressure, including a petition with over 1000000 signatures.
  • President Macron allegedly was hesitant and considered a range of options, including a reduction of the percentage of reimbursement.
  • Apparently, the minister stood up for science and, as rumored, even put her job on the line.
  • In July 2019, she announced the end of reimbursement and was quoted saying J’ai toujours dit que je suivrais l’avis de la Haute Autorité de santé (HAS), j’ai donc décidé d’engager la procédure de déremboursement total

Since then, homeopathy has indeed been banned from reimbursement. Here is a short update on the current situation:

After the disengagement of the French Social Security system, the world leader in homeopathy has been trying to convince complementary health insurance companies to take up the torch of large-scale reimbursement. Its seduction operation includes a third-party payment solution to boost sales.

From 1 January 2021, homeopathy is no longer reimbursed by Social Security. In March 2020, Boiron, the largest producer of homeopathics, began a restructuring that led to the loss of 560 jobs in France and the closure of one-third of its 31 production and distribution sites. On Thursday, the site of Chauray (Deux-Sèvres) closed after 33 years of activity.

… The CEO of Boiron, Valérie Lorentz-Poinsot, does not have words strong enough to describe the decision of the former Minister of Health, Agnès Buzyn, to delist homeopathy. Since the view issued in June 2019 by the French Health Authority (HAS) noting the ineffectiveness of 1,100 of these products previously reimbursed by the French health service, the reimbursement of homeopathics was reduced from 30% to 15% in 2020, then to 0% on 1 January 2021.

PS

Oh, I almost forgot to mention: the stocks in Boiron roughly halved during the last 3 years

 

I am pleased to report that our ‘resident homeopathic doctor’ from Germany, Dr. Heinrich Huemmer, posted a review of my new book on Amazon. As his comments are in German, I translated them which was not easy because they are confusing and confused. Now that it’s done, I cannot resist the temptation to show them to you (the references were inserted by me, and refer to my comments below):

First of all, the author, who as a scientist [1] once had a thoroughly positive attitude towards homeopathy [and in a meta-analysis even attested to it significantly positive results in a certain clinical picture [2]], explains the principles and procedures in homeopathy in a clear and objective manner.
In explaining the principle of potentization, however, Ernst’s one-dimensional and completely unscientific matter-bound, quasi-medieval understanding of science shines through for the first time. With the assertion, “both the dilution and the similarity rule contradict the laws of nature” he clearly reveals his unscientific thinking, whereby he could have easily relativized this by an inserted differentiation “presently, known laws of nature”. [3] And not even the following sentence “…we understand very well that it can function only if the known laws of nature would be invalid” is agreed by critically thinking natural scientists. [3] Also the assertion: “The totality of this evidence does not show that homeopathic remedies would be no more than placebo”, is countered by a well-known – belonging to the skeptic movement – expert of the homeopathic study situation with the remark: “Furthermore, you should read my statements and those of the INH more carefully again: Our statement is that there is no robust/reliable/convincing evidence for efficacy beyond placebo. ALSO NOT “NONE” but “none conclusive”, which yes makes a difference in absolute numbers. Just like “no beer” is different than “not a good beer”. ” [4] Since patients usually turn to homeopathy only when so-called scientific medicine negates their illnesses and accordingly has nothing to offer them [5], Ernst’s reference to the fact that patients could “endanger their health” is to be seen as a cheap attempt at discrediting. [6] The reference that this assessment comes from the Australian National Health and Medical Research Council is not without a particularly piquant note, since this NHMRC may have to be held responsible for a particularly infamous attempt at scientific fraud to the disadvantage of homeopathy. [7] Also, the alleged “fact” that “[positive] experiences […] are the result of a long, empathetic, sympathetic encounter with a homoeopath…” can be disproved by immediate – also diagnostically verified – cures, which occurred immediately without a long admission or which failed to appear even after several intensive anamneses under most sympathetic admission against all expectations…..[8] Finally Ernst’s argument “the benefit-cost-argument of homeopathy is not positive” is an absolute air number, because the saving of 1 €/patient and year (in case of abolition of the homeopathy-reimbursement) would not even allow a free new glasses-nose-pad…. [9]

________________________

  1. I am not sure where Homeopathy Heinrich Huemmer (HHH) got the claim from that I, as a scientist, once had a thoroughly positive attitude towards homeopathy. This is not even remotely true! As a very young clinician (40 years ago), I once was quite impressed by homeopathy, never as a scientist (for full details, see my memoir). What HHH seems to display here is his very own misunderstanding about science and scientists: if they are for real (i.e. not pseudoscientists like many of those who research homeopathy), scientists try not to let their personal attitudes get in the way of good science.
  2. I presume that HHH refers here to this meta-analysis: Homeopathy for postoperative ileus? A meta-analysis. I fear that HHH has yet to learn how to read a scientific paper. Our conclusions were: There is evidence that homeopathic treatment can reduce the duration of ileus after abdominal or gynecologic surgery. However, several caveats preclude a definitive judgment. These results should form the basis of a randomized controlled trial to resolve the issue. 
  3. This made me laugh! Does HHH think that only the handful of homeopathic loons who claim that homeopathy has a scientific basis in the unknown laws of nature are truly scientific? And all the rest are unscientific?
  4. I doubt that anyone can understand this passage, perhaps not even HHH. My conclusion that “the totality of this evidence does not show that homeopathic remedies are more than placebo”  merely expresses what even most homeopaths would admit and is unquestionably correct.
  5. This statement is untrue in more than one way. Firstly, responsible clinicians never tell a patient that they have nothing more to offer, simply because this is never the case – there is always something a good clinician can do for his/her patient, even if it is just in terms of palliation or moral support. Secondly, we know that German patients opt to use homeopathy for all sorts of reasons, including as first-line therapy and not as a last resort.
  6. In the book, I refer (and reference the source) to the phenomenon that many homeopaths discourage their patients from vaccination. Unfortunately, this is no ‘cheap attempt’, it is the sad reality. HHH does not even try to dispute it.
  7. HHH does not like the NHMRC report. Fair enough! But he omits to mention that, in the book, I list a total of 4 further official verdicts. Does HHH assume they are all fraudulent? Is there perhaps a worldwide conspiracy against homeopathy?
  8. We all know that HHH is enormously proud of his only publication to which he refers here (on this blog, he must have mentioned it a dozen times). However, in the book, I refer to an RCT for making my point. Which is more convincing, a case report or an RCT?
  9. Here HHH simply demonstrates that he has not understood the concept of cost-effectiveness.

So, what we have here is a near-perfect depiction of a homeopath’s way of thinking. But there is worse in HHH’s comment< I fear.

My book (of 224 pages) scrutinizes – as even its title states – not one but 40 types of so-called alternative medicine (SCAM); 20 of the most effective and 20 of the most dangerous SCAMs. In addition, it covers (in ~ 50 pages) many general topics (like ‘WHAT IS EVIDENCE? or WHY IS SCAM SO POPULAR?). It includes over 200 references to published papers. Yet, HHH reviews and judges the book by commenting exclusively on the meager 5 pages dedicated to homeopathy!

If that does not exemplify the limitations of the homeopathic mind, please tell me what does.

THANK YOU, HHH, FOR MAKING THIS SO CLEAR TO US!

About one in three individuals have elevated blood pressure. This is bad news because hypertension is one of the most important risk factors for cardiovascular events like strokes and heart attacks. Luckily, there are many highly effective approaches for treating elevated blood pressure (diet, life-style, medication, etc.), and the drug management of hypertension has improved over the last few decades.

But unfortunately all anti-hypertensive drugs have side-effects and some patients look towards so-called alternative medicine (SCAM) to normalise their blood pressure. Therefore, we have to ask: are SCAMs effective treatments for hypertension? Because of the prevalence of hypertension, this is a question of great importance for public health.

In 2005, I addressed the issue by publishing a review entitled ‘Complementary/alternative medicine for hypertension: a mini-review‘. Here is its abstract:

Many hypertensive patients try complementary/alternative medicine for blood pressure control. Based on extensive electronic literature searches, the evidence from clinical trials is summarised. Numerous herbal remedies, non-herbal remedies and other approaches have been tested and some seem to have antihypertensive effects. The effect size is usually modest, and independent replications are frequently missing. The most encouraging data pertain to garlic, autogenic training, biofeedback and yoga. More research is required before firm recommendations can be offered.

Since the publication of this paper, more systematic reviews have become available. In order to get an overview of this evidence, I conducted a few simple Medline searches for systematic reviews (SRs) of SCAM published between 2005 and today. I included only SRs that were focussed on just one specific therapy as a treatment of just one specific condition, namely hypertension (omitting SRs with titles such as ‘Alternative treatments for cardiovascular conditions’). Reviews on prevention were also excluded. Here is what I found (the conclusions of each SR is quoted verbatim):

  1. A 2020 SR of auricular acupressure including 18 RCTs: The results demonstrated a favorable effect of auricular acupressure to reduce blood pressure and improve sleep in patients with hypertension and insomnia. Further studies to better understand the acupoints and intervention times of auricular acupressure are warranted.
  2. A 2020 SR of Chinese herbal medicines (CHM) including 30 studies: CHM combined with conventional Western medicine may be effective in lowering blood pressure and improving vascular endothelial function in patients with hypertension.
  3. A 2020 SR of Tai chi including 28 RCTs: Tai Chi could be recommended as an adjuvant treatment for hypertension, especially for patients less than 50 years old.
  4. A 2020 SR of Tai chi including 13 trials: Tai chi is an effective physical exercise in treating essential hypertension compared with control interventions.
  5. A 2020 SR of Tai chi including 31 controlled clinical trials: Tai Ji Quan is a viable antihypertensive lifestyle therapy that produces clinically meaningful BP reductions (i.e., 10.4 mmHg and 4.0 mmHg of SBP and DBP reductions, respectively) among individuals with hypertension.
  6. A 2020 SR of pycnogenol including 7 trials:  the present meta-analysis does not suggest any significant effect of pycnogenol on BP.
  7. A 2019 SR of Policosanol including 19 studies: Policosanol could lower SBP and DBP significantly; future long term studies are required to confirm these findings in the general population.
  8. A 2019 SR of dietary phosphorus including 14 studies: We found no consistent association between total dietary phosphorus intake and BP in adults in the published literature nor any randomized trials designed to examine this association.
  9. A 2019 SR of ginger including 6 RCTs: ginger supplementation has favorable effects on BP.
  10. A 2019 SR of corn silk tea (CST) including 5 RCTs: limited evidence showed that CST plus antihypertensive drugs might be more effective in lowering blood pressure compared with antihypertensive drugs alone.
  11. A 2019 SR of blood letting including 7 RCTs: no definite conclusions regarding the efficacy and safety of BLT as complementary and alternative approach for treatment of hypertension could be drew due to the generally poor methodological design, significant heterogeneity, and insufficient clinical data.
  12. A 2019 SR of Xiao Yao San (XYS) including 17 trials: XYS adjuvant to antihypertensive drugs maybe beneficial for hypertensive patients in lowering BP, improving depression, regulating blood lipids, and inhibiting inflammation.
  13. A 2019 SR of Chinese herbal medicines including 9 RCTs: Chinese herbal medicine as complementary therapy maybe beneficial for postmenopausal hypertension.
  14. A 2019 Cochrane review of guided imagery including 2 trials: There is insufficient evidence to inform practice about the use of guided imagery for hypertension in pregnancy.
  15. A 2019 Cochrane review of acupuncture including 22 RCTs: At present, there is no evidence for the sustained BP lowering effect of acupuncture that is required for the management of chronically elevated BP.
  16. A 2019 SR of wet cupping including 7 RCTs: no firm conclusions can be drawn and no clinical recommendations made.
  17. A 2019 SR of transcendental meditation (TM) including 9 studies: TM was associated with within-group (but not between-groups) improvements in BP.
  18. A 2019 SR of yoga including 49 trials: yoga is a viable antihypertensive lifestyle therapy that produces the greatest BP benefits when breathing techniques and meditation/mental relaxation are included.
  19. A 2018 SR of mindfulness-based stress reduction (MBSR) including 5 studies: The MBSR program is a promising behavioral complementary therapy to help people with hypertension lower their blood pressure
  20. A 2018 SR of beetroot juice (BRJ) including 11 studies: BRJ supplementation should be promoted as a key component of a healthy lifestyle to control blood pressure in healthy and hypertensive individuals.
  21. A 2018 SR of taurine including 7 studies: ingestion of taurine at the stated doses and supplementation periods can reduce blood pressure to a clinically relevant magnitude, without any adverse side effects.
  22. A 2018 SR of acupuncture including 30 RCTs: there is inadequate high quality evidence that acupuncture therapy is useful in treating hypertension.
  23. A 2018 SR of co-enzyme Q10 including 17 RCTs: CoQ10 supplementation may result in reduction in SBP levels, but did not affect DBP levels among patients with metabolic diseases.
  24. A 2018 SR of a traditional Chinese formula Longdanxiegan decoction (LDXGD) including 9 trials: Due to poor methodological quality of the included trials, as well as potential reporting bias, our review found no conclusive evidence for the effectiveness of LDXGD in treating hypertension.
  25. A 2018 SR of viscous fibre including 22 RCTs: Viscous soluble fiber has an overall lowering effect on SBP and DBP.
  26. A 2017 SR of yoga breathing exercise (pranayama) including 13 studies: The pranayama’s effect on BP were not robust against selection bias due to the low quality of studies. But, the lowering BP effect of pranayama is encouraging.
  27. A 2017 SR of dietary nitrate supplementation including 13 trials: Positive effects of medium-term dietary nitrate supplementation on BP were only observed in clinical settings, which were not corroborated by more accurate methods such as 24-h ambulatory and daily home monitorings.
  28. A 2017 SR of Vitamin D supplementation including 8 RCTs: vitamin D is not an antihypertensive agent although it has a moderate SBP lowering effect.
  29. A 2017 SR of pomegranate including 8 RCTs: The limited evidence from clinical trials to date fails to convincingly show a beneficial effect of pomegranate on blood pressure
  30. A 2017 SR of ‘forest bathing’ including 20 trials:  This systematic review shows a significant effect of Shinrin-yoku on reduction of blood pressure.
  31. A 2017 SR of Niuhuang Jiangya Preparation (NHJYP) including 12 RCTs: Our review indicated that NHJYP has some beneficial effects in EH patients with liver-yang hyperactivity and abundant phlegm-heat syndrome.
  32. A 2017 SR of Chinese medicines (CM) including 24 studies: CM might be a promising approach for the elderly with isolated systolic hypertension, while the evidence for CM employed alone was insufficient.
  33. A 2017 SR of beetroot juice including 22 RCTs: Our results demonstrate the blood pressure-lowering effects of beetroot juice and highlight its potential NO3-independent effects.
  34. A 2017 SR of blueberry including 6 RCTs: the results from this meta-analysis do not favor any clinical efficacy of blueberry supplementation in improving BP
  35. A 2016 Cochrane review of co-enzyme Q10 including 3 RCTs: This review provides moderate-quality evidence that coenzyme Q10 does not have a clinically significant effect on blood pressure.
  36. A 2016 SR of Nigella sativa including 11 RCTs: short-term treatment with N. sativa powder can significantly reduce SBP and DBP levels.
  37. A 2016 SR of vitamin D3 supplementation including 30 RCTs: Supplementation may be beneficial at daily doses >800 IU/day for <6 months in subjects ≥50 years old.
  38. A 2016 SR of anthocyanin supplementation including 6 studies: results from this meta-analysis do not favor any clinical efficacy of supplementation with anthocyanins in improving blood pressure.
  39. A 2016 SR of flaxseed including 15 trials: This meta-analysis of RCTs showed significant reductions in both SBP and DBP following supplementation with various flaxseed products.
  40. A 2016 SR of massage therapy including 9 RCTs: This systematic review found a medium effect of massage on SBP and a small effect on DBP in patients with hypertension or prehypertension.
  41. A 2015 SR of massage therapy including 24 studies: There is some encouraging evidence of massage for essential hypertension.
  42. A 2015 SR of transcendental meditation (TM) including 12 studies: an approximate reduction of systolic and diastolic BP of -4.26 mm Hg (95% CI=-6.06, -2.23) and -2.33 mm Hg (95% CI=-3.70, -0.97), respectively, in TM groups compared with control groups.
  43. A 2015 SR of Zhen Wu Decoction (ZWD) including 7 trials: This systematic review revealed no definite conclusion about the application of ZWD for hypertension due to the poor methodological quality, high risk of bias, and inadequate reporting on clinical data.
  44. A 2015 SR of acupuncture including 23 RCTs: Our review provided evidence of acupuncture as an adjunctive therapy to medication for treating hypertension, while the evidence for acupuncture alone lowing BP is insufficient.
  45. A 2015 SR of xuefu zhuyu decoction (XZD) including 15 studies: This meta-analysis provides evidence that XZD is beneficial for hypertension.
  46. A 2015 SR of Shenqi pill including 4 RCTs: This systematic review firstly provided no definite evidence for the efficacy and safety of Shenqi pill for hypertension based on the insufficient data.
  47. A 2015 SR of Jian Ling Decoction (JLD) including 10 trials: Owing to insufficient clinical data, it is difficult to draw a definite conclusion regarding the effectiveness and safety of JLD for essential hypertension.
  48. A 2015 SR of Chinese herbal medicines (CHM) including 5 trials: No definite conclusions about the effectiveness and safety of CHM for resistant hypertension could be drawn.
  49. A 2015 SR of Chinese medicines (CM) including 27 RCTs: When combined with Western medines, CM as a complementary treatment approach has certain effects for the control of hypertension and protection of target organs.
  50. A 2015 SR of berberine including 17 RCTs: This study indicates that berberine has comparable therapeutic effect on type 2 DM, hyperlipidemia and hypertension with no serious side effect.
  51. A 2015 SR of garlic including 9 double-blind trials: Although evidence from this review suggests that garlic preparations may lower BP in hypertensive individuals, the evidence is not strong.
  52. A 2015 SR of chlorogenic acids (CGAs) including 5 studies: CGA intake causes statistically significant reductions in systolic and diastolic blood pressures.
  53. A 2014 SR of omega-3 fatty acid supplementation including 70 RCTs:  provision of EPA+DHA reduces systolic blood pressure, while provision of ≥2 grams reduces diastolic blood pressure.
  54. A 2014 SR of green tea including 20 RCTs: Green tea intake results in significant reductions in systolic blood pressure
  55. A 2014 SR of probiotics including 9 studies: consuming probiotics may improve BP by a modest degree, with a potentially greater effect when baseline BP is elevated, multiple species of probiotics are consumed, the duration of intervention is ≥8 weeks, or daily consumption dose is ≥10(11) colony-forming units.
  56. A 2014 SR of yoga including 17 trials: The evidence for the effectiveness of yoga as a treatment of hypertension is encouraging but inconclusive.
  57. A 2014 SR of yoga including 7 RCTs: very low-quality evidence was found for effects of yoga on systolic and diastolic blood pressure.
  58. A 2014 SR of yoga including 120 studies: yoga is an effective adjunct therapy for HPT and worthy of inclusion in clinical guidelines.
  59. A 2014 SR of moxibustion:  a beneficial effect of using moxibustion interventions on KI 1 to lower blood pressure compared to antihypertensive drugs.
  60. A 2014 SR of acupuncture including 4 sham-controlled RCTs: acupuncture significantly lowers blood pressure in patients taking antihypertensive medications.
  61. A 2014 SR of Tuina including 7 RCTs: The findings from our review suggest that Tuina might be a beneficial adjuvant for patients with EH
  62. A 2014 SR of ‘kidney tonifying’ (KT) Chinese herbal mixture including 6 studies: Compared with antihypertensive drugs alone, KT formula combined with antihypertensive drugs may provide more benefits for patients with SH.
  63. A 2014 SR of Tongxinluo capsule including 25 studies : There is some but weak evidence about the effectiveness of TXL in treating patients with hypertension.
  64. A 2014 SR of moxibustion including 5 RCTs: no confirm conclusion about the effectiveness and safety of moxibustion as adjunctive treatment for essential hypertension could be made
  65. A 2013 SR of Qi Ju Di Huang Wan (QJDHW) including 10 RCTs: QJDHW combined with antihypertensive drugs might be an effective treatment for lowering blood pressure and improving symptoms in patients with essential hypertension.
  66. A 2013 SR of yoga including 17 studies: Yoga can be preliminarily recommended as an effective intervention for reducing blood pressure.
  67. A 2013 SR of Tianma Gouteng Yin (TGY) including 22 RCTs: No confirmed conclusion about the effectiveness and safety of TGY as adjunctive treatment for essential hypertension … could be made.
  68. A 2013 SR of Zhen Gan Xi Feng Decoction (ZGXFD) including 6 RCTs: ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH
  69. A 2013 SR of Tianmagouteng decoction including 9 RCTs: Tianmagouteng decoction can decrease both systolic and diastolic blood pressure.
  70. A 2013 SR of fish oil including 17 RCTs: The small but statistically significant effects of fish-oil supplements in hypertensive participants in this review have important implications for population health and lowering the risk of stroke and ischaemic heart disease.
  71. A 2013 SR of acupuncture including 35 RCTs: While there are some evidences that suggest potential effectiveness of acupuncture for hypertension, the results were limited by the methodological flaws of the studies.
  72. A 2013 SR of yoga including 6 studies: There is some encouraging evidence of yoga for lowering SBP and DBP.
  73. A 2012 SR of spinal manipulation therapy (SMT) including 10 studies: There is currently a lack of low bias evidence to support the use of SMT as a therapy for the treatment of
  74. A 2012 SR of vitamin C including 29 trials: In short-term trials, vitamin C supplementation reduced SBP and DBP.
  75. A 2012 SR of magnesium supplementation including 22 trials: magnesium supplementation appears to achieve a small but clinically significant reduction in BP, an effect worthy of future prospective large randomised trials using solid methodology.
  76. A 2012 SR of Banxia Baizhu Tianma Decoction (BBTD) including 16 RCTs: There is encouraging evidence of BBTD for lowering SBP, but evidence remains weak.
  77. A 2012 SR of Liu Wei Di Huang Wan (LWDHW) including 6 RCTs: LWDHW combined with antihypertensive drugs appears to be effective in improving blood pressure and symptoms in patients with essential hypertension.
  78. A 2012 SR of aromatherapy including 5 studies: The existing trial evidence does not show convincingly that aromatherapy is effective for hypertension.
  79. A 2012 empty Cochrane review: As no trials could be identified, no conclusions can be made about the role of TGYF in the treatment of primary hypertension.
  80. A 2012 SR of yoga including 10 studies: Not only does yoga reduce high BP but it has also been demonstrated to effectively reduce blood glucose level, cholesterol level, and body weight, major problems affecting the American society.
  81. A 2011 SR of L-arginine including 11 RCTs: This meta-analysis provides further evidence that oral L-arginine supplementation significantly lowers both systolic and diastolic BP.
  82. A 2011 SR of soy isoflavones including 14 RCTs: Soy isoflavone extracts significantly decreased SBP but not DBP in adult humans, and no dose-response relationship was observed.
  83. A 2010 SR of moxibustion including 4 RCTs: There is insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.
  84. A 2010 SR of acupunctures including 20 studies: Because of the paucity of rigorous trials and the mixed results, these findings result in limited conclusions. More rigorously designed and powered studies are needed.
  85. A 2010 SR of cupping including 3 trials: the evidence is not significantly convincing to suggest cupping is effective for treating hypertension.
  86. A 2010 empty Cochrane review: There is insufficient evidence to support the benefit of Roselle for either controlling or lowering blood pressure in patients with hypertension.
  87. A 2009 SR of acupuncture including 11 RCTs: the notion that acupuncture may lower high BP is inconclusive.
  88. A 2008 SR of transcendental meditation including 9 studies: The regular practice of Transcendental Meditation may have the potential to reduce systolic and diastolic blood pressure by approximately 4.7 and 3.2 mm Hg, respectively.
  89. A 2008 SR of relaxation therapies including 25 trials:  the evidence in favour of a causal association between relaxation and blood pressure reduction is weak.
  90. A 2007 SR of qigong including 12 RCTs: There is some encouraging evidence of qigong for lowering SBP, but the conclusiveness of these findings is limited.
  91. A 2007 SR of co-enzyme Q10 including 12 trials: coenzyme Q10 has the potential in hypertensive patients to lower systolic blood pressure by up to 17 mm Hg and diastolic blood pressure by up to 10 mm Hg without significant side effects.
  92. A 2007 SR of stress reduction programs including 106 studies: Available evidence indicates that among stress reduction approaches, the Transcendental Meditation program is associated with significant reductions in BP.
  93. A 2006 Cochrance review of magnesium supplementation including 12 RCTs:  the evidence in favour of a causal association between magnesium supplementation and blood pressure reduction is weak and is probably due to bias.
  94. A 2006 Cochrane review of calcium supplementation including 13 RCTs: evidence in favour of causal association between calcium supplementation and blood pressure reduction is weak and is probably due to bias.

ALMOST 100 NEW SRs!

To be honest, if I had known the volume of the material, I would probably not have tackled this task. Since the publication of my mini-review in 2005, there has been an explosion of similar papers:

  • 1 in 2005
  • 2 in 2006
  • 3 in 2007
  • 2 in 2008
  • 1 in 2009
  • 4 in 2010
  • 2 in 2011
  • 8 in 2012
  • 8 in 2013
  • 12 in 2014
  • 12 in 2015
  • 6 in 2016
  • 9 in 2017
  • 7 in 2018
  • 12 in 2019

As this is based on very simple Medline searches, the list is certainly not complete. Despite this fact, several conclusions seem to emerge:

  1. There is no shortage of SCAMs that have been tested for hypertension.
  2. Most seem to have positive effects; in many cases, they seem too good to be true.
  3. Many of the SRs are of poor methodological quality, based on poor quality primary studies, published in less than reputable journals. Some SRs, for instance, include studies without a control group which is likely to lead to false-positive overall conclusions about the effectiveness of the SCAM in question.
  4. In recent years, there are more and more SRs by Chinese authors focussed on Chinese herbal mixtures that are unknown and unobtainable outside China. These SRs are invariably based on studies published in Chinese language in journals that are inaccessible. This means it is almost impossible for the reader, reviewer or editor to check their accuracy. The reliability of the conclusions of these SRs must therefore be doubted.
  5. Most of the primary studies included in the SRs lack long-term data. Thus the usefulness of the SCAM in question is questionable.
  6. With several of the SCAMs, the dose of the treatment and treatment schedule is less than clear. For instance, one might ask how frequently a patient should have acupuncture to control her hypertension.
  7. Some of the SCAMs assessed in these SRs seem of doubtful practicality. For instance, it might not be feasible nor economical for patients to receive regular acupuncture to manage their blood pressure.
  8. Several contradictions emerge from some of the SRs of the same modality. This is particularly confusing because SRs are supposed to be the most reliable type of evidence. In most instances, however, the explanation can easily be found by looking at the quality of the SRs. If SRs are based on uncontrolled studies, or if they fail to critically evaluate the reliability of the included primary trials, they are likely to arrive at conclusions that are too positive. Examples for such confusion are the multiple SRs of co-enzyme Q10 or the three yoga SRs of 2014.
  9. Because of this confusion, SCAM advocates are able to select false-positive SRs to support their opinion that SCAM is effective.
  10. Despite a substantial amount of positive evidence, none of the SCAMs have become part of the routine in the management of hypertension. A 2013 statement by the American Heart Association entitled Beyond medications and diet: alternative approaches to lowering blood pressure: a scientific statement from the american heart association concluded that it is reasonable for all individuals with blood pressure levels >120/80 mm Hg to consider trials of alternative approaches as adjuvant methods to help lower blood pressure when clinically appropriate. A suggested management algorithm is provided, along with recommendations for prioritizing the use of the individual approaches in clinical practice based on their level of evidence for blood pressure lowering, risk-to-benefit ratio, potential ancillary health benefits, and practicality in a real-world setting. 

What lessons might this brief overview of SRs teach us? I think the following points are worth considering:

  • Systematic reviews are the best type of evidence we have for estimating the effectiveness of treatments. But it is essential that they include a strong element of CRITICAL evaluation of the primary studies. Without it, a SR is incomplete and potentially counter-productive.
  • The primary studies of SCAM are far too often of poor quality. This means that researchers should thrive to improve the rigour of their investigations.
  • Both poor-quality primary studies and uncritically conducted SRs are prone to yielding findings that are too good to be true.
  • Editors and reviewers have a responsibility to prevent the publication of trials and SRs that are of poor quality and thus likely to mislead us.
  • Those SCAMs that have shown promising effects on hypertension (for instance Tai chi) should now be submitted to further independent scrutiny to find out whether their efficacy and usefulness can be confirmed, for instance, by 24-h ambulatory and daily home blood pressure monitoring and studies testing their acceptability in real life settings. Subsequently, we ought to determine whether the SCAM in question can be reasonably integrated in routine blood pressure management.
  • The adjunctive use of a SCAM that has been proven to be effective and practical seems a reasonable approach. Yet, it requires proper scientific scrutiny.
  • There is a paucity of cost-effectiveness studies and investigations of the risks of SCAM which needs to be addressed before any SCAM is considered for routine care.
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