Edzard Ernst

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

This randomized clinical trial tested the effects of laying on of hands (LooH) as a complementary therapy to kinesiotherapy, on pain, joint stiffness, and functional capacity of older women with knee osteoarthritis (KOA) compared to a control group.

Participants were assigned into 3 groups:

  1. LooH with a spiritual component (Group – SPG),
  2. LooH without a spiritual component (Group – LHG),
  3. a control group receiving no complementary intervention (Control Group – CG).

Patients were assessed at baseline, 8 weeks, and 16 weeks. Primary outcomes were joint stiffness and functional capacity (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), and pain (WOMAC and visual analogue scale). Secondary outcomes were anxiety, depression, mobility, and quality of life. Differences between groups were evaluated using an intention-to-treat approach.

A total of 120 women with KOA were randomized (40 participants per group). At 8 weeks, SPG differed significantly from the LHG for WOMAC Functional Status; Anxiety levels; and also from the CG for all outcomes with exception of WOMAC Stiffness. After 16 weeks, SPG differed significantly from the LHG only for WOMAC Functional Status and also from the CG for all outcomes with exception of WOMAC Stiffness and timed up-and-go.

The authors concluded that the results suggest that LooH with a “spiritual component” may promote better long-term functional outcomes than both LooH without a “spiritual component” and a control group without LooH.

This is an interesting study which seems well designed. Its findings are surprising and lack scientific plausibility. Therefore, sceptics will find it hard to accept the results and suspect some hidden bias or confounding to have caused it rather than the laying on of hands. SCAM enthusiasts would then probably claim that such an attitude exemplifies the bias of sceptics.

So, what can be done to find out who is right and who is wrong?

Whenever we are faced with a surprising finding based on a seemingly rigorous trial, it is wise to realise that there  is a plethora of possible explanations and that speculations are usually not very helpful. There is always a danger of a clinical trial producing false or misleading findings. This could be due to a plethora of reasons such as error, undetected bias or confounding, fraud, etc.

What we really need is an independent replication – better two.

‘Infodemics’ are outbreaks of false information including rumours, stigma, and conspiracy theories. All of these have been common during the COVID-19 pandemic. The detection, assessment, and response to rumours, stigma, and conspiracy theories in real time are a challenge.

An international team of researchers followed and examined COVID-19-related rumours, stigma, and conspiracy theories circulating on online platforms, including fact-checking agency websites, Facebook, Twitter, and online newspapers, and their impacts on public health. Information was extracted between December 31, 2019 and April 5, 2020, and descriptively analysed. The team performed a content analysis of the news articles to compare and contrast data collected from other sources.

The researchers identified 2,311 reports of rumours, stigma, and conspiracy theories in 25 languages from 87 countries. Claims were related to:

  • illness, transmission and mortality (24%),
  • control measures (21%),
  • treatment and cure (19%),
  • cause of disease including the origin (15%),
  • violence (1%),
  • and miscellaneous (20%).

Of the 2,276 reports for which text ratings were available, 1,856 claims were false (82%).

The authors concluded that misinformation fuelled by rumours, stigma, and conspiracy theories can have potentially serious implications on the individual and community if prioritized over evidence-based guidelines. Health agencies must track misinformation associated with the COVID-19 in real time, and engage local communities and government stakeholders to debunk misinformation.

These findings are as perplexing as they are frightening. On this blog, we have since the beginning of the pandemic focussed on the SCAM for COVID-19. We have seen that this health crisis provided an occasion for almost any quackery on the planet:

  • homeopaths,
  • supplement salesmen,
  • TCM-practitioners,
  • chiropractors,
  • anti-vaxxers,
  • Siddha-doctors,
  • Vitamin-peddlers,
  • politicians,
  • evangelists,
  • acupuncturists,
  • herbalists,
  • essential oil salesmen.

They all crept out of the woodwork. Their methods may differ, but their aim seems to be the same: to make a fast buck regardless of how many people their activities might kill.

The ketogenic diet (KD) is a currently popular high-fat, low-carbohydrate diet; it limits the intake of glucose which results in the production of ketones by the liver and their uptake as an alternative energy source by the brain. KD is an effective treatment for intractable epilepsy. In addition, it is being promoted as a so-called alternative medicine (SCAM) for a wide range of conditions, including:

  • weight loss,
  • cognitive and memory enhancement,
  • type II diabetes,
  • cancer,
  • neurological and psychiatric disorders.

However, these indications are not supported by good evidence.

A side effect of KD is “keto flu,” a syndrome of transient symptoms generally reported as occurring within the first few weeks of adhering to the diet. These symptoms can feel similar to the flu and are caused by the body adapting to a new diet consisting of very little carbohydrates.

Ketones are by-products of fat breakdown and become the main energy source when following the KD. Normally, fat is reserved as a secondary fuel source to use when glucose is not available. This switch to burning fat for energy is called ketosis. It occurs during specific circumstances, including starvation, fasting … or KD. The KD reduces carbohydrates typically to under 50 grams per day. This drastic reduction may cause withdrawal-like symptoms, similar to those experienced when weaning off an addictive substance.

A recent paper aimed to characterize the pattern of symptoms, severity and time course of keto flu as related by users of online forums. Online forums referring to “keto flu,” “keto-induction,” or “keto-adaptation” in the URL were identified. Passages describing personal experiences of keto flu were categorized with reference to pattern of symptoms, severity, time course, and remedies proposed.

The search criteria identified 75 online forums, 43 met inclusion criteria and contained 448 posts from 300 unique users. Seventy-three made more than one post (mean 3.12, range 2-11). Descriptors of personal experience of keto flu, reported by 101 of 300 users, included 256 symptom descriptions involving 54 discrete symptoms. Commonest symptoms were “flu,” headache, fatigue, nausea, dizziness, “brain fog,” gastrointestinal discomfort, decreased energy, feeling faint and heartbeat alterations.

Symptom reports peaked in the first and dwindled after 4 weeks. Resolution of keto flu symptoms was reported by 8 users between days 3 and 30 (median 4.5 ). Severity of symptoms, reported by 60 users in 40 forums, was categorized as mild (N = 15), moderate (N = 23), or severe (N = 22). Eighteen remedies were proposed by 121 individual users in 225 posts. The following treatments were most frequently recommended (numbers represent the number of times of each recommendation was made):

Increase sodium intake 58
Supplement with electrolytes 38
Drink broth (including bone broth, stock cubes) 27
Increase magnesium 25
Increase potassium 24

I find this paper interesting, not least because of the unusual methodological approach. It seems to confirm that, even though the KD is often recommended as safe, it is associated with significant side-effects. One adverse effect remained unmentioned, while leading to more people discontinuing the diet than any other side-effect: the fact that the diet is quite unpalatable on the long-run and soon puts people off eating. This, of course, might be one mechanism by which KD leads to weight loss.

During the last decades, the sales-figures for so-called alternative medicine (SCAM) have been increasing steadily and substantially. A recent report predicts this trend to continue:

… The global market for alternative and complementary medicines is projected to experience substantial growth in the next few years. The rising expenditure of the healthcare facilities is considered as the major factor that is likely to encourage the growth of the overall market in the coming years. In addition, the increasing number of initiatives being taken by Governments across the globe to promote alternative and complementary medicines is projected to accelerate the market’s growth. Thanks to these factors, the global alternative and complementary medicine market is likely to exhibit a promising growth rate in the near future.

A significant rise in the number of initiatives by NGOs and government organizations to encourage the use of alternative and complementary medicines is estimated to bolster global market in the near future. In addition to this, technological advancements in this field and the rising inclination of consumers towards these medicines and practices are likely to offer lucrative growth opportunities for the leading players operating in the alternative and complementary medicine market across the globe. However, the lack of scientific results is expected to hamper the overall growth of the market in the next few years…

From a regional perspective, Europe is considered as one of the leading segment, thanks to the significant revenue contribution in the last few years. This region is expected to account for a large share of the global alternative and complementary medicine market with the rising use of botanicals. In addition to this, the increasing awareness among consumers regarding the availability of effective alternative and complementary medicines and the benefits they offers are expected to encourage the growth of the Europe market in the coming years.

Furthermore, with the rising popularity of medical tourism, the alternative and complementary medicine market in Asia Pacific is projected to witness a steady growth in the next few years. Moreover, the presence of a large number of new players operating in this region is likely to offer promising growth opportunities over the forecast period. The Middle East and Africa segment is anticipated to experience a healthy growth in the alternative and complementary medicine market in the near future.

The global market for alternative and complementary medicines is presently at a highly competitive stage and is predicted to experience an intense level of competition among the leading players in the coming years. The prominent players in the market are focusing on the expansion of the product portfolio so as to attract a large number of consumers across the globe. This is likely to help them in creating a brand name and acquiring a leading position in the global market. Some of the leading players operating in the alternative and complementary medicine market across the globe are Herb Pharm, Yoga Tree, Quantum Touch Inc., Helio USA Inc., Pure encapsulations, Inc., Pacific Nutritional Inc., Deepure Plus, Herbal Hills, Iyengar Yoga Institute, The Healing Company, and Nordic Naturals.

Yes, I know, this is little more than hot air mixed with platitudes and advertisements to purchase the full report. I used to buy such documents for my department and research but was invariably disappointed. They provide are expensive and of very little of value.

Yet, one thing has been confirmed over the years: the prediction of steady growth of the SCAM-industry is rarely wrong (certain sections, such as homeopathy, have been shrinking in some regions, but the industry as a whole is financially healthy). The scientific evidence seems to get less and less convincing, yet consumers buy more and more of these products. They may do little good and have the potential to cause quite a bit of harm, but consumers continue to waste their money on them.

The question is: why?

There are, of course, many reasons. An important one is that the gullible public wants to believe in SCAM, and the SCAM-industry is highly skilled in misleading us. What is worse: many governments, instead of limiting the damage, are mildly or even overtly supportive of the SCAM-industry.

Whenever I contemplate this depressing state of affairs, I realise that my blog is important. It is only a drop in the ocean, I know, but still…

 

 

 

We probably all think we know what is meant by ‘pseudo-science’. But, in fact, the more you think about it, the less certain you are likely to become. Many very smart people have tried shed some light on this question and, in the end, had to admit that it is far from clear.

In his book ‘Decision Making and Rationality in the Modern World‘, Keith Stanovich makes a fresh attempt to tackle the problem. Here is a list of criteria that he deems important:

• The use of psychobabble – words that sound scientific, but are used incorrectly, or in a misleading manner. For example, “energy therapies” for psychological problems are often premised on biofeedback, meridian lines, quantum energies, and a host of other concepts that may sound impressive, but lack evidence.

• A substantial reliance on anecdotal evidence. Evidence for pseudoscience is typically anecdotal and consequently difficult to verify. For a class example, instructors may want to show students the Q-Ray bracelet website 1 and read the many quotes submitted by Q-Ray users. Although the quotes sound compelling, there is no scientific evidence to support any claims attached to them. In fact, the Q-Ray company lost a lawsuit in 2011 and was ordered to refund over $11 million dollars to people who purchased a Q-Ray bracelet.

• Extraordinary claims in the absence of extraordinary evidence (Truzzi, 1978Sagan, 1995). In pseudosciences, assertions are often highly implausible in light of existing knowledge yet are not backed by convincing evidence. For a class example, instructors may wish to describe how infomercials promoting Q-Ray bracelets state that the “bracelet rips [pain] right out of the body 2.” and are “designed to optimize your natural positive energy 1.”

• Unfalsifiable claims – Most pseudoscientific claims are incapable of being refuted in principle. For example, proponents of traditional Chinese medicine (TCM) believe the human body has an invisible energy force called Qi (Zollman and Vickers, 1999). Qi is a crucial component of TCM, even though it cannot be measured or tested scientifically.

• An absence of connectivity to other research (Stanovich, 2010). Connectivity refers to the extent to which assertions build on extant knowledge. For example, homeopathic practitioners state that homeopathic treatments become stronger as they become more dilute, and that water has memory. Both of these claims run counter to established scientific knowledge (Singh and Ernst, 2008).

• Absence of adequate peer review. Peer review is far from perfect, but it is a key safeguard against error. Instructors may wish to encourage students to contrast the claims advanced by the authors of peer-reviewed versus non-peer-reviewed articles.

• Lack of self-correction. Pseudosciences frequently persist despite refutation. Often, proponents of pseudoscience will use the idea that since the treatment or idea has been used for thousands of years it must be correct (e.g., astrology), an error often called the ad antiquetem fallacy (or, argument from antiquity).

Yes, I know, nothing fundamentally new here. Nonetheless, I thought the list was thought-provoking, particularly as it harps back to themes which we have discussed regularly on this blog. Stanovich’s list is certainly not comprehensive. Feel free, if you think you can add new aspects to the features that characterise pseudoscience.

One of the many issues that needs addressing about chiropractic is its safety. On this blog, we have had dozens of posts and debates on this topic. Today, I want to try and summarise them by providing a fictitious dialogue between a critic and a chiropractor.

Here we go:

Critic (CR): It seems to me that most of the chiros I talk to are convinced that their hallmark therapy, spinal manipulation, is risk-free.

Chiro (CH): Hallmark therapy? Not true! Osteopaths, physios, doctors they all use spinal manipulation.

CR: I know, but name me a profession that employs it more regularly than you chiros.

CH: In any case, it is as good as risk-free; nothing is totally devoid of risk, but chiropractic spinal manipulation (CSMT) is generally very safe, because we are better trained at it than the others.

CR: Do you say that because you believe it or because you know it?

CH: I know it.

CR: That means you have the evidence to prove it?

CH: Yes, of course. Over the years, I have treated over a thousand patients and never heard of any problems.

CR: Without a monitoring system of adverse events that occur after chiropractic spinal manipulation, this is pretty meaningless.

CH: Monitoring systems do not establish causality.

CR: No, but they are a start and can tell you whether there is a problem that requires looking into.

CH: Let me remind you please that the question of safety is foremost an issue for conventional medicine; this is why a monitoring system is useful for drugs. We actually do not need one, because CSMT is safe.

CR: Are you sure?

CH: Yes, V DabbsW J Lauretti have shown this very clearly in their seminal paper comparing drug treatments with chiropractic. 

CR: The much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim. Is there not a better comparison for supporting your point?

CH: Not as far as I know. But you can trust our collective experience: CSMT is safe!

CR: Don’t you think that the issue is too important to rely purely on experience? Your collective experience can be very misleading, you know.

CH: Then tell me why chiros pay only a fraction of the insurance premium compared to doctors.

CR: Yes, that is the argument many chiros love. But it also is a very poor one: doctors treat patients who are often very ill, while chiros treat mostly sore backs. Don’t you think that explains a lot about the difference in insurance premiums?

CH: Perhaps, but if you claim CSMT to be harmful, how about you supporting your claim with evidence?

CR: Sure, the best is to review systematically all prospective studies on the topic; and if you do this, the conclusion is that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

CH: I bet these are studies done by people who are against chiropractic.

CR: No, actually the primary studies were all done by chiropractors.

CH: Minor transient problems! These are merely what we expect; things often need to get worse before they get better.

CR: Imagine that a drug company claims such BS about the side-effects of a new drug.

CH: But that’s different!

CR: In what way?

CH: Big Pharma is only out to make money.

CR: And chiros?

CH: That’s different too.

CR: What about the serious adverse events like vertebrobasilar accidents, disk herniation, and cauda equina syndrome? Are you going to deny they exist?

CH: Some of those serious complications, while rare, are conditions that existed prior to CSMT being performed with the practitioner missing it upon initial examination.

CR: How do you know?

CH: I know this from experience.

CR: I already told you that experience is unreliable.

CH: Then show me the evidence that I am wrong.

CR: No, you have to come up with the evidence; the burden of proof is evidently on your shoulders.

CH: Whatever! As long as there is no good evidence, I cannot accept that serious complications are a real problem.

CR: That’s just fine: you say “as long as there is no good evidence…” and, at the same time, you prevent good evidence from emerging by preventing a decent AE monitoring system.

CH: I always knew that one cannot have a reasonable discussion with you. I consider that I have won this debate; this issue is now closed.

 

Chronic rhinosinusitis (CRS) is a common disorder. This trial tested the efficacy of individualized homeopathy (IH) in comparison with placebo in patients with CRS.

This double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analogue scale scores, and five numeric rating scales (0-10) assessing intensity of sneezing, rhinorrhoea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen’s d) were calculated on the intention-to-treat sample.

The two groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonicaLycopodium clavatumSulphurNatrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.

The authors who are affiliated with the following institutions:

  • Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.
  • Department of ENT, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.
  • Department of Paediatrics, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.
  • Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.
  • Department of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India.
  • Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India.

concluded that there was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion.

Sorry, but this is the wrong conclusion. In the name of honesty and research integrity, it should read something like this:

Our study failed to show that IH has a significant effect on CRS.

But of course, this is no surprise. Why should IH work for CRS? The only remotely interesting finding here, in my view, is the fact that the authors noted not a single homeopathic aggravation (i. e. the occurrence of the ‘drug picture’ in a patient and thus a kind of homeopathic ‘proving’). Using IH, homeopaths would expect aggravations with some regularity. Could it be that homeopathic aggravations (and ‘provings’) are, like all effects of homeopathy, the result of misinterpretation, fantasy and wishful thinking? Investigating the issue systematically, we found already 17 years ago that this systematic review does not provide clear evidence that the phenomenon of homeopathic aggravations exists.

You have probably guessed it: I am not a fan of Donald Trump (he made several previous appearances on this blog, see here, here here and here). There are many things that I dislike about him, and his attitude towards vaccination is but one of them. Researchers from Australia and from my own University (!) have conducted two studies on this subject which I find extraordinary and important. Here is their abstract:

Donald Trump is the first U.S. President to be on the record as having anti-vaccination attitudes. Given his enormous reach and influence, it is worthwhile examining the extent to which allegiance to Trump is associated with the public’s perceptions of vaccine safety and efficacy. In both Study 1 (N = 518) and Study 2 (N = 316), Trump voters were significantly more concerned about vaccines than other Americans. This tendency was reduced to non-significance after controlling for conspiracist ideation (i.e., general willingness to believe conspiracy theories) and, to a lesser degree, political conservatism. In Study 2, participants were later exposed to real Trump tweets that either focused on his anti-vaccination views, or focused on golf (the control condition). Compared to when the same respondents were sampled a week earlier, there was a significant increase in vaccine concern, but only among Trump voters who were exposed to the anti-vaccination tweets. The effects were exclusively negative: there was no evidence that anti-vaccination Trump tweets polarized liberal voters into becoming more pro-vaccination. In line with the social identity model of leadership, Study 2 indicates that some leaders do not simply represent the attitudes and opinions of the group, but can also change group members’ opinions.

I find this paper so important and excellent that I take the liberty of quoting from the authors’ discussion:

Both studies showed that people who voted for Trump in the 2016 Presidential election were more concerned about vaccines than other voters. When it came to general concern about vaccines, this “Trump effect” was entirely accounted for by the fact that Trump voters are not only more politically conservative than other Americans but also (and independently) more predisposed to believe conspiracy theories. In fact, the tendency for Trump voters to have greater concerns about the MMR vaccine in particular was not explained so much by their political conservatism as it was by their conspiracist ideation.

Study 1 illustrates that Trump voters are particularly prone to anti-vaccination attitudes. Study 2 further demonstrates that these attitudes are not static: it shows that a revered, prototypical ingroup member can actively exacerbate this propensity to endorse factually unfounded beliefs.

One overarching debate about the influence of political leaders is the extent to which they shape supporters’ views, or merely reflect them. Study 2 makes clear that the “Trump effect” is not merely a case of Trump holding a mirror to people’s pre-existing views: his messages have the power to change attitudes. As such, future research needs to
take seriously the impact of Trump as a change-agent, one that is impeding the broader campaign to increase vaccination uptake and to eliminate infectious diseases.

________________________

So, the ‘Trump-Effect’ on vaccination attitudes is strongly negative. This leads me to suspect that the ‘Trump-Effect’ on many other issues is just as profoundly detrimental. For the sake not just of public health, let us hope that the US public will dismiss their dangerous president when they go to the ballot in just a few weeks time.

On this blog, I have discussed the adverse events (AEs) of spinal manipulative therapy (SMT) with some regularity, and we have seen that ~ 50% of patients who receive SMT from a chiropractor experience some kind of AE. In addition there are many serious complications. In my book, I discuss, apart from the better-known vascular accidents followed by a stroke or death, the following:

  • atlantoaxial dislocation,
  • cauda equina syndrome,
  • cervical radiculopathy,
  • diaphragmatic paralysis,
  • disrupted fracture healing,
  • dural sleeve injury,
  • haematoma,
  • haematothorax,
  • haemorrhagic cysts,
  • muscle abscess,
  • muscle abscess,
  • myelopathy,
  • neurologic compromise,
  • oesophageal rupture
  • pneumothorax,
  • pseudoaneurysm,
  • soft tissue trauma,
  • spinal cord injury,
  • vertebral disc herniation,
  • vertebral fracture,
  • central retinal artery occlusion,
  • nystagmus,
  • Wallenberg syndrome,
  • ptosis,
  • loss of vision,
  • ophthalmoplegia,
  • diplopia,
  • Horner’s syndrome.

Considering this long list, we currently have far too little reliable information. A recent publication offers further information on this important topic.

The aim of this study was to identify beliefs, perceptions and practices of chiropractors and patients regarding benign AEs post-SMT and potential strategies to mitigate them. Clinicians and patients from two chiropractic teaching clinics were invited to respond to an 11-question survey exploring their beliefs, perceptions and practices regarding benign AEs post-SMT and strategies to mitigate them.

A total of 39 clinicians (67% response rate) and 203 patients (82.9% response rate) completed the survey. The results show that:

  • 97% of the chiropractors believed benign AEs occur.
  • 82% reported their own patients have experienced an AE.
  • 55% of the patients reported experiencing benign AEs post-SMT, with the most common symptoms being pain/soreness, headache and stiffness.
  • 61.5% of the chiropractors reported trying a mitigation strategy with their patients.
  • Yet only 21.2% of patients perceived their clinicians had tried any mitigation strategy.
  • Chiropractors perceived that patient education is most likely to mitigate benign AEs, followed by soft tissue therapy and/or icing after SMT.
  • Patients perceived stretching was most likely to mitigate benign AEs, followed by education and/or massage

 

The authors concluded that this is the first study comparing beliefs, perceptions and practices from clinicians and patients regarding benign AEs post-SMT and strategies to mitigate them. This study provides an important step towards identifying the best strategies to improve patient safety and improve quality of care.

The question that I have often asked before, and I am bound to ask again after seeing such results, is this:

If there were a drug that causes temporary pain/soreness, headache and stiffness in 55% of all patients (plus an unknown frequency of a long list of serious complications), while being of uncertain benefit, do you think it would still be on the market?

 

Opioid over-use has become a huge problem, particularly in the US. Proponents of complementary and alternative medicine (CAM) – or so-called alternative medicine (SCAM) as I prefer to call it these days – have been keen to suggest that they have a solution to this problem. But is this really true? So far, the evidence was slim, to say the least.

This systematic review evaluated the effectiveness of the integrative medicine (IM) approach or any of the CAM therapies to reduce or cease opioid use in CP patients.

The electronic searches yielded 5,200 citations. Twenty-three studies were selected. Eight studies were randomized controlled trials, 7 were retrospective studies, 4 studies were prospective observational, 3 were cross-sectional, and one was quasi-experimental. The majority of the studies showed that opioid use was reduced significantly after using IM. Cannabinoids were among the most commonly investigated approaches in reducing opioid use, followed by multidisciplinary approaches, cognitive-behavioural therapy (CBT), and acupuncture. The majority of the studies had limitations related to sample size, duration, and study design.

The authors concluded that there is a small but defined body of literature demonstrating positive preliminary evidence that the IM approach including CAM therapies can help in reducing opioid use. As the opioid crisis continues to grow, it is vital that clinicians and patients be adequately informed regarding the evidence and opportunities for IM/CAM therapies for CP.

The authors who are from the Canadian College of Naturopathic Medicine in Ontario, Canada (and who claim to have no conflict of interest) seem to have forgotten to discuss some not so unimportant details and questions:

  • Why did they include studies with extremely weak designs in their review (such studies are likely to produce false positive findings)?
  • Why did they consider treatments such as CBT as CAM (most experts would characterise them as conventional psychological therapies)?
  • Why did they not conduct a separate analysis of the RCT-evidence (is it because that would not have generated the result they wanted?)?

My reading of the RCTs – the only type of study that might give a reliable answer to the question posed- is that they do not show a opioid-sparing effect of CAM use, particularly if we eliminate those studies that tested treatments which are not truly CAM. In any case, as I have said several times before, the way to avoid over-prescribing opioid is not through using more therapies of doubtful effectiveness but through prescribing less opioids. And to achieve that, doctors should just do what they learnt in medical school (at least I did all those years ago).

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