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

methodology

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When tested rigorously, the evidence for so-called alternatives medicine (SCAM) is usually weak or even negative. This fact has prompted many SCAM enthusiasts to become utterly disenchanted with rigorous tests such as the randomised clinical trial (RCT). They seem to think that, if the RCT fails to generate the findings we want, let’s use different methodologies instead. In other words, they are in favour of observational studies which often yield positive results.

This line of thinking is prevalent in all forms of SCAM, but probably nowhere more so that in the realm of homeopathy. Homeopaths see that rigorous RCTs tend not to confirm their belief and, to avoid cognitive dissonance, they focus on observational studies which are much more likely to confirm their belief.

In this context, it is worth mentioning a recent article where well-known homeopathy enthusiasts have addressed the issue of observational studies. Here is their abstract:

Background: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades.

Method: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide.

Results: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe “real-world” care settings and can assist with the design and inform the results of randomised controlled trails.

Conclusions: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

In their paper, the authors state this:

It is important to realize three areas where observational research can be valuable. For one, as already mentioned, it can be valuable as a preparatory type of research for designing good randomized studies. Second, it can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Additionally, it can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. This might also lead to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions.

My comments to this are as follows:

  1. Observational research can be valuable as a preparatory type of research for designing good randomized studies. This purpose is better fulfilled by pilot studies (which are often abused in SCAM).
  2. Observational research can be valuable as a stand-alone type of research, where pragmatic or ethical reasons stand against conducting a randomized study. Such situations rarely arise in the realm of SCAM.
  3. Observational research can be valuable as the only adequate method where choices are involved: for instance, in any type of lifestyle research or where patients have very strong preferences, such as in homeopathy and other CAM. I fail to see that this is true.
  4. Observational research leads to a diversification of research efforts and a broader, more realistic, picture of the effects of therapeutic interventions. The main aim of research into the effectiveness of SCAM should be, in my view, to determine whether the treatment per se works or not. Observational studies are likely to obscure the truth on this issue.

Don’t get me wrong, I am not saying that observational studies are useless; quite to the contrary, they can provide very important information. But what I am trying to express is this:

  • We should not allow double standards in medical research. The standards and issues of observational research as they exist in conventional medicine must also apply to SCAM.
  • Observational studies cannot easily determine cause and effect between the therapy and the outcome.
  • Observational studies cannot be a substitute for RCTs.
  • Depending on their exact design, observational studies measure the outcome caused by a whole range of factors, including the therapy per se, the placebo-effect, the natural history of the disease, the regression towards the mean.
  • Observational studies are particularly useful in effectiveness research, AFTER the efficacy of a therapy has been established by RCTs.
  • If RCT fail to show that a therapy is effective and observational studies seem to indicate that they work, the therapy in question is probably a placebo.
  • SCAM-enthusiasts’ preference for observational studies is transparently due to motivated reasoning.

Pisa syndrome (PS) is a condition in which there is sustained involuntary flexion of the body and head to one side and slight rotation of the trunk so the person appears to lean like the Leaning Tower of Pisa. The PS can occur as a complication of Parkinson’s disease (PD). It can also be an adverse effect of some medications. It is characterized by a trunk lateral flexion higher than 10 degrees which is reversible when lying. The underlying pathophysiological mechanisms responsible for the development of PS are poorly understood. One pathophysiological hypothesis is that PS in PD is caused by an altered verticality perception, due to a somatosensory impairment.

The management of PS remains a challenge. Physiotherapy with early rehabilitation emphasising stretching exercises for the external oblique and paraspinal muscles is usually recommended. Therapy is also needed to improve static, dynamic posture and the control of pain symptoms. Osteopathic Manipulative Treatment (OMT) is also sometimes advocated for PS, but does it work?

The aim of the study was to assess OMT efficacy on postural control in PD-PS patients by stabilometry. In this single-blinded trial the investigators studied 24 PD-PS patients, 12 of whom were randomly assigned to receive a multidisciplinary physical therapy protocol (MIRT) and sham OMT, while the other 12 received OMT plus MIRT for one month. The primary endpoint was the eye closed sway area assessment after the intervention. Evaluation of trunk lateral flexion (TLF) was also performed.

At one month, the sway area of the OMT group significantly decreased compared to placebo (mean delta OMT – 326.00±491.24 mm2, p = 0.01). The experimental group TLF showed a mean inclination reduction of 3.33 degrees after treatment (p = 0.044, mean d = 0.54). Moreover, a significant positive association between delta ECSA and delta TLF was observed (p = 0.04, r = 0.46).

The authors concluded that among PD-PS patients, MIRT plus OMT showed preliminary evidence of postural control and TLF improvement, compared to the control group.

The authors entitled their paper ‘Efficacy of Osteopathic Manipulative Treatment on Postural Control in Parkinsonian Patients With Pisa Syndrome: A Pilot Randomized Placebo-Controlled Trial’. As a pilot study, it should not test efficacy but explore the feasibility of a definitive trial. The fact the authors report outcome data, indicates to me that this is, in fact, not a pilot study, but a hopelessly underpowered clinical trial. This means that the findings could be due merely to chance alone. And this, in turn, means that the researchers owe it to their patients to conduct a properly powered RCT.

Am I the only one who is tired of hearing that, in India, homeopathy is doing wonders for the current pandemic? All of the reports that I have seen are based on little more than hearsay, anecdotes or pseudo-science. If anyone really wanted to find out whether homeopathy works, they would need more than that; in fact, they would need to conduct a clinical trial.

But wait!

As it happens, there are already ~500 clinical trials of homeopathy. Many show positive effects, but the reliable ones usually don’t. Crucially, the totality of the evidence fails to be positive. So, running further studies is hardly a promising exercise. In fact, considering how utterly implausible homeopathy is, it even seems like an unethical waste of resources.

But many homeopaths disagree, particularly those in India. And it has been reported that several trials have been given the go-ahead in India and are now up and running. This regrettable fact is being heavily exploited for swaying public opinion in favour of homeopathy. The way I see it, the situation is roughly this:

  • a few trials of homeopathy are being set up;
  • they are designed by enthusiasts of homeopathy who lack research expertise;
  • therefore their methodology is weak and biased towards generating a false-positive result;
  • while this is going on, the homeopathic propaganda machine is running overtime;
  • when the results will finally emerge, they will get published in a 3rd rate journal;
  • homeopaths worldwide will celebrate them as a triumph for homeopathy;
  • critical thinkers will be dismayed at their quality and will declare that the conclusions drawn by over-enthusiastic homeopaths are not valid;
  • in the end, we will be exactly where we were before: quasi-religious believers in homeopathy will feel vexed because their findings are not accepted in science, and everyone else will be baffled by the waste of time, opportunity and resources as well as by the tenacity of homeopaths to make fools of themselves.

But criticising is easy; doing it properly is often more difficult.

So, how should it be done?

The way I see it, one should do the following:

  • carefully consider the implausibility of homeopathy;
  • thoroughly study the existing evidence on homeopathy;
  • abandon all plans to study homeopathy in the light of the above.

But this hardly is inconceivable considering the current situation in India. If further studies of homeopathy are unavoidable, the following procedure might therefore be reasonable:

  1. assemble a team of experts including trial methodologists, statisticians, epidemiologists and homeopaths;
  2. ask them to design a rigorous protocol of one or two studies that would provide a definitive answer to the research question posed;
  3. make sure that, once everyone is happy with the protocol, all parties commit to abiding by the findings that will emerge from these trials;
  4. conduct the studies under adequately strict supervision;
  5. evaluate the results according to the protocol;
  6. publish them in a top journal;
  7. do the usual press-releases, interviews etc.

In India, it seems that the last point in this agenda came far too early. This is because, in this and several other countries, homeopathy has become more a belief system than a medicine. And because it is about belief, the believers will avert any truly meaningful and rigorous test of homeopathy’s efficacy.

 

 

In the wake of both the NEJM and the LANCET withdrawing two potentially influential papers due unanswered questions about the source and reliability of the data, one has to ask how good or bad the process of peer review is.

Peer review is the evaluation of work by one or more people with similar competences as the producers of the work (peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. It normally involves multiple steps:

  1. Authors send their manuscript to a journal of their choice for publication.
  2. The journal editor has a look at it and decides whether to reject it straight away (for instance, because the subject area is not of interest) or whether to send it out to referees for examination (often to experts suggested by the authors of the submission).
  3. The referees (usually 2 or 3) have the opportunity to reject or accept the invitation to review the submission.
  4. If they accept, they review the paper and send their report to the editor (usually following a deadline).
  5. The editor tries to come to a decision about publication; often the referees are not in agreement, and a further referee has to be recruited.
  6. Even if the submission is potentially publishable, the referees will have raised several points that need addressing. In such cases, the editor sends the submission back to the original authors asking them to revise the article.
  7. The authors do their revision (often following a deadline) and re-submit their paper.
  8. Now the editor can decide to either publish it or send it back to the referees asking them whether they feel their criticisms have been adequately addressed.
  9. Depending on the referees’ verdicts, the editor makes the final decision and informs all the involved parties accordingly.
  10. If the paper was accepted, it then goes into production.
  11. When this process is finished, the authors receive the proofs for final a check.
  12. Eventually, the paper is published and the readers of the journal may scrutinise it.
  13. Often this prompts comment which may get published.
  14. In this case, the authors of the original paper may get invited to write a reply.
  15. Finally the comments and the reply are published in the journal side by side.

The whole process takes time, sometimes lots of time. I have had papers that took almost two years from submissions to publications. This delay seems tedious and, if the paper is important, unacceptable (if it is not important, it should arguably not be published at all). Equally unacceptable is the fact that referees are expected to do their reviewing for free. The consequence is that many referees do their reviewing less than well.

When I was still at Exeter, I had plenty of opportunity to see the problems of peer review from the reviewers perspective. At a time, I accepted about 5 reviews per week, and in total I surely have reviewed over 1000 papers. I often recommended inviting a statistician to do a specialist review of the stats. Only rarely were such suggestions accepted by the journal editors. Very often I recommended rejecting a submission because it was rubbish, and occasionally, I told the editor that there was a strong suspicion of the paper being fraudulent. The editors very often (I estimate in about 50% of cases) ignored my suggestions and comments and published the papers nonetheless. If the editor did follow my advice to reject a paper, I regularly saw it published elsewhere later (usually in a less well-respected journal). Several times, an author of a submission contacted me directly after seeing my criticism of his paper. Occasionally this resulted in unpleasantness, once or twice even in threats. Eventually I realised that improving the publications in the realm of SCAM was a Sisyphean task, became quite disenchanted with all this and accepted less and less reviews. Today, I do only very few.

I had even more opportunity to see the peer review process from the author’s perspective. All authors must have suffered from unfair or incompetent reviews and most will have experienced the frustrations of the endless delays. Once (before my time in alternative medicine) a reviewer rejected my paper and soon after published results that were uncannily similar to mine. In alternative medicine, researchers tend to be rather emotional about their subject. Imagine, for instance, the review you might get from Dana Ullmann of a trial of homeopathy that fails to show what he believes in.

Finally, since 40 years, I have also had the displeasure of experiencing peer review as an editor. This often seemed like trying to sail between the devil and the deep blue sea. Editors want to fill their journals with the best science they can find. But all too often, they receive the worst science they can imagine. They are constantly torn by tensions pulling them in opposite directions. And they have to cope not just with poor quality submissions but also with reviewers who miss deadlines and do their work badly.

So, peer review is fraught with problems! The trouble is that there are few solutions that would keep a better check on the reliability of science. Peer review, it often seemed to me, is the worst idea, except for all others. If peer review is to survive (and I think it probably will), there are a few things that could, from my point of view, be done to improve it:

  1. Make it much more attractive for the referees. Payment would be the obvious thing – and by Jove, the big journals like the LANCET and NEJM could afford it. But recognising refereeing academically would be even more important. At present, academic careers depend largely of publications; if they also depended on reviewing, experts would queue up to do it.
  2. The reports of the referees should get independently evaluated according to sensible criteria. These data could be conflated an published as a criterion of academic standing. Referees who fail to to a good job would spoil their chances to get re-invited for this task.
  3. Speed up the entire process. Waiting months on months is hugely counter-productive for all concerned.
  4. Today many journals ask authors for the details of experts who are potential reviewers of their submission and then send the paper in question to them for review. I find this ridiculous! No author I know of has ever resisted the temptation to name people who are friends or owe a favour. Journals should afford the extra work to find who the best independent experts on any particular subject are.

None of this is simple or fool-proof or even sure to work well, of course. But surely it is worth trying to get peer-review right. The quality of future science depends on it.

Cochrane reviews have the reputation to be the most reliable evidence available anywhere. They are supposed to be independent, rigorous, transparent and up-to-date. Usually, this reputation is justified, in my view. But do the 54 Cochrane reviews of acupuncture quoted in my previous post live up to it?

If one had to put the entire body of evidence in a nutshell, it would probably look something  like this:

TOTAL NUMBER OF SYSTEMATIC REVIEWS = 54

POSITIVE CONCLUSIONS BASED ON MORE THAN ONE HIGH QUALITY STUDY = 2

FAILURE TO REACH CONVINCINGLY POSITIVE CONCLUSIONS = 52

The two positive reviews are on:

1) prevention of migraine

2) prevention of tension-type headache

Both of the positive reviews are by Linde et al.

Allow me to raise just a few further critical points:

  1. If I counted correctly, 19 of the 54 reviews are authored entirely by Chinese authors. Why could this be a problem? One reason could be that many Chinese authors seem to be biased in favour of acupuncture. Another reason could be that data fabrication is rife in China.
  2. Many if not most of the primary studies are published in Chinese. This means that it is impossible for most non-Chinese co-authors of the review as well as for the referees of the paper to check the accuracy of the data extraction.
  3. I counted a total of 15 reviews which were by authors who one could categorise as outspoken enthusiasts of acupuncture. In these cases, one might be concerned about the trustworthiness of the review’s conclusion.
  4.  Many (some would say most) of the reviews cover subject areas which are frankly bizarre. Who would, for instance, consider acupuncture a plausible treatment for Glaucoma, Mumps or chronic hepatitis B?
  5. Despite almost all of the reviews demonstrating that there is no good reason to recommend acupuncture for the condition in question, hardly any of them draw a transparent, helpful and clear conclusion. One example might suffice: the review of acupuncture for hordeolum concluded that “Low‐certainty evidence suggests that acupuncture with or without conventional treatments may provide short‐term benefits for treating acute hordeolum…” Its Chinese authors reached this conclusion on the basis of 6 primary studies (all from China) which were all of lousy quality. In such a case, the only justified conclusion would be, in my view, something like this: THERE IS NO RELIABLE EVIDENCE …

Despite these serious limitations and avoidable confusions, the totality of the evidence from these 54 Cochrane reviews does send an important message: there is hardly a single condition for which acupuncture is clearly, convincingly and indisputably effective. What I find most regrettable, however, is that the Cochrane Collaboration allowed the often biased review authors to obscure this crucial message so thoroughly. One needs a healthy portion of critical thinking to get through to the truth here – and how many fans of acupuncture possess such a thing?

When I first saw this press-release, I thought it was a hoax. After all, it came from a most dubious homeopathic source. Then I read it again and was no longer sure.

What do you think?

Here it is in full:

Santa Clara, Cuba, April 3,2020 (Prensa Latina) The homeopathic medicine Prevengho-VIR began to be administered as a measure to confront the Covid-19 in this province of central Cuba.

Dr. Mirtha Rosa Hernandez, head of the Department of the Elderly in Villa Clara, reported that the supply of the preparation began in the Grandparents’ Homes and Elderly Homes of the territory, which has 184,000 people over 60 years old, 23.9 percent of the local universe. The medicine is administered by doctors and nurses of the basic working group where the Grandparents’ Homes and Nursing Homes are located in the 13 municipalities of this province.

This homeopathic medicine comes in a 10-milliliter bottle, and the daily dosage is 5 drops, thrice a day; while on the tenth day a reactivation of the initial dose is performed. It is aimed at preventing the respiratory diseases in this risk group, in addition to other medical conditions, such as dengue.

In the upcoming days it will be extended to the Maternal Homes. It is administered by the doctors and the nurses from the basic work group of the senior homes.

She said, that besides avoiding the new coronavirus the formula is also aimed at preventing respiratory diseases in this risk group, in addition to others such as dengue fever.

This medicine can also be administered to children under 10 years old, pregnant women, nursing mothers, and patients with liver disorders.

Combination Medicine
Anas berberiae 200
Baptisia tinctora 200
Bascilinum 30
Pyrogenum 200
Eupetorium perf 200
Influezinum 200
Arsenicum Album 200

As I said, I was not sure whether this was for real. Is it possible that even officials are so stupid, brainwashed or gullible to go for homeopathy in such a serious situation?

In an attempt to find out, I did a little search and quickly found that the story has been reported by multiple media. This, for instance, is what the Miami Herald reported:

As scientists around the world speed up clinical trials to find a cure or vaccine for the coronavirus, the Cuban government will begin distributing a homeopathic remedy to the elderly and other vulnerable people to “prevent” the spread of the disease, a top health official said.

Dr. Francisco Durán, national director of Epidemiology at the Ministry of Public Health, said in a press conference on Sunday that “sublingual drops” of the compound PrevengHo-Vir “prevent different diseases such as influenza, the common cold, dengue, and emerging viral infections such as this one.”

On Monday, Durán tried to correct his statements and said that the product “does not prevent contagion” but rather “increases resistance, the body’s defenses against a certain virus.”

Several state media outlets reported that PrevengHo-Vir is already being used in various Cuban provinces to treat the elderly and other groups vulnerable to the coronavirus. There is no internet record of PrevengHo-Vir, other than press reports about the announcement of its distribution in Cuba.

So, it’s not a hoax!

In this case, let me try to predict what will happen next:

  • When the pandemic is over, the Cubans will publish mortality rates achieved with their homeopathic prevention [A].
  • They will compare them to data from a cohort that did not receive the homeopathic treatment [B].
  • Neither of the data-sets will be transparent and nobody will be able to check its reliability.
  • The comparison will yield a significant difference in favour of homeopathy.
  • The Cubans will use this to market their remedy.
  • The world of homeopathy will use it as a proof that homeopathy is effective (it wouldn’t be the first time).

Nothing wrong with that, some will say. Others who understand research methodology will, however, point out that these data are less than convincing.

In such case/control studies, one large group of patients [A] is compared to another group [B]. Group A has been treated homeopathically, while group B received no homeopathy. Any difference in outcome between A and B might be due to a range of circumstances that are unrelated to the homeopathic treatment, for instance:

  • group A might have been less ill than group B,
  • group A might have been better nourished,
  • group A might have benefited from better hygiene,
  • group A might have received better care,
  • group B might have received treatments that made the situation not better but worse,
  • the researchers might have prettified the data to make group A look better.

Such concerns are not totally unfounded; after all, Cuba seems to have a long history of making irresponsible claims for their homeopathic products.

Resveratrol is one of the most popular dietary supplements. It is an antioxidant found in red grape skin, Japanese knotweed, blueberries and other berries. Resveratrol is available as dietary supplements from red wine extracts, grape seed extracts, Japanese knotweed extracts and other plants. The amount and purity of resveratrol in supplements varies significantly; absorption in the gut is low.

While, for many supplements, there is no or very little research, this one has a huge amount. So, has reseveratrol any proven health effects demonstrated in clinical trials?

The answer is encouraging.

This abstract provides a useful summary:

Resveratrol is a polyphenolic nutraceutical that exhibits pleiotropic activities in human subjects. The efficacy, safety, and pharmacokinetics of resveratrol have been documented in over 244 clinical trials, with an additional 27 clinical trials currently ongoing. Resveretrol is reported to potentially improve the therapeutic outcome in patients suffering from diabetes mellitus, obesity, colorectal cancer, breast cancer, multiple myeloma, metabolic syndrome, hypertension, Alzheimer’s disease, stroke, cardiovascular diseases, kidney diseases, inflammatory diseases, and rhinopharyngitis. The polyphenol is reported to be safe at doses up to 5 g/d, when used either alone or as a combination therapy. The molecular basis for the pleiotropic activities of resveratrol are based on its ability to modulate multiple cell signaling molecules such as cytokines, caspases, matrix metalloproteinases, Wnt, nuclear factor-κB, Notch, 5′-AMP-activated protein kinase, intercellular adhesion molecule, vascular cell adhesion molecule, sirtuin type 1, peroxisome proliferator-activated receptor-γ coactivator 1α, insulin-like growth factor 1, insulin-like growth factor-binding protein 3, Ras association domain family 1α, pAkt, vascular endothelial growth factor, cyclooxygenase 2, nuclear factor erythroid 2 like 2, and Kelch-like ECH-associated protein 1. Although the clinical utility of resveratrol is well documented, the rapid metabolism and poor bioavailability have limited its therapeutic use. In this regard, the recently produced micronized resveratrol formulation called SRT501, shows promise. This review discusses the currently available clinical data on resveratrol in the prevention, management, and treatment of various diseases and disorders. Based on the current evidence, the potential utility of this molecule in the clinic is discussed.

This is a comprehensive review but it fails to critically assess the quality of the clinical trials. Once we do that, we are likely to get disappointed. Many studies are just not up to the mark.

And if we consult a Cochrane review, our enthusiasm for resveratrol disappears completely: Currently, research is insufficient for review authors to evaluate the safety and efficacy of resveratrol supplementation for treatment of adults with T2DM [type 2 diabetes mellitus]. The limited available research does not provide sufficient evidence to support any effect, beneficial or adverse, of four to five weeks of 10 mg to 1000 mg of resveratrol in adults with T2DM. Adequately powered RCTs reporting patient-relevant outcomes with long-term follow-up periods are needed to further evaluate the efficacy and safety of resveratrol supplementation in the treatment of T2DM.

So, for the time being, I might just continue to obtain my resveratrol in very small but regular doses from red wine, I think.

 

 

The objective of this trial, just published in the BMJ, was to assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura. The study was designed as a multi-centre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician. It was conducted in 7 hospitals in China with 150 acupuncture naive patients with episodic migraine without aura.

They were given the following treatments:

  • 20 sessions of manual acupuncture at true acupuncture points plus usual care,
  • 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care,
  • usual care alone over 8 weeks.

The main outcome measures  were change in migraine days and migraine attacks per 4 weeks during weeks 1-20 after randomisation compared with baseline (4 weeks before randomisation).

A total of 147 were included in the final analyses. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham. No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%).

The authors concluded that twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.

Considering the many flaws in most acupuncture studies discussed ad nauseam on this blog, this is a relatively rigorous trial. Yet, before we accept the conclusions, we ought to evaluate it critically.

The first thing that struck me was the very last sentence of its abstract. I do not think that a single trial can ever be a sufficient reason for changing existing guidelines. The current Cochrance review concludes that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Thus, one could perhaps argue that, together with the existing data, this new study might strengthen its conclusion.

In the methods section, the authors state that at the end of the study, we determined the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin. And in the results section, they report that they found no significant difference between the manual acupuncture and sham acupuncture groups for patients’ ability to correctly guess their allocation status.

I find this puzzling, since the authors also state that they tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. They fail to report data on this but this attempt is usually successful in the majority of patients. In the control group, where non-penetrating needles were used, no de-qi could be generated. This means that the two groups must have been at least partly de-blinded. Yet, we learn from the paper that patients were not able to guess to which group they were randomised. Which statement is correct?

This may sound like a trivial matter, but I fear it is not.

Like this new study, acupuncture trials frequently originate from China. We and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. If that is so, one does not need to read the paper, one already knows that it is positive before one has even seen it. Neither do the researchers need to conduct the study, one already knows the result before the trial has started.

You don’t believe the findings of my research nor those of others?

Excellent! It’s always good to be sceptical!

But in this case, do you believe Chinese researchers?

In this systematic review, all RCTs of acupuncture published in Chinese journals were identified by a team of Chinese scientists. An impressive total of 840 trials were found. Among them, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

So, at least three independent reviews have found that Chinese acupuncture trials report virtually nothing but positive findings. Is that enough evidence to distrust Chinese TCM studies?

Perhaps not!

But there are  even more compelling reasons for taking evidence from China with a pinch of salt:

A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations. “Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Chinese research organisations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

So, am I claiming the new acupuncture study just published in the BMJ is a fake?

No!

Am I saying that it would be wise to be sceptical?

Yes.

Sadly, my scepticism is not shared by the BMJ’s editorial writer who concludes that the new study helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence based treatment.

Call me a sceptic, but that statement is, in my view, hard to justify!

 

[If you do not like black humour or sarcasm, please do NOT read this post!!!]

Donald Trump just announced that, at Easter, he wants to see churches packed, his way of saying the lock-down is over because it is damaging the economy. Many others have put forward similar arguments and have pointed out that caring for the vulnerable, sick, old, etc. creates an economic burden that might eventually kill more people than it saves (see for instance ‘Economic crash could cost more lives than coronavirus, study warns‘).

Many people have also argued that homeopathy is unjustly vilified because it is truly a wholesome and safe medicine that should be used routinely. The notion here is that, alright, the evidence is not brilliant, but 200 years of experience and millions of fans cannot be ignored.

I have been wondering whether these two lines of thinking could not be profitably combined. Here is my suggestion based on the following two axioms.

  1. The economy is important for all our well-being.
  2. Homeopaths have a point in that the value of experience must not be ignored.

What follows is surprisingly simple: in view of the over-riding importance of the economy, let’s prioritise it over health. As it would look bad to deny those poor corona victims all forms of healthcare, let’s treat them homeopathically. This would make lots of people happy:

  • those who think the economy must take precedent,
  • those who fear the huge costs of saving corona patients (homeopathy is very cheap),
  • those who argued for decades that we never gave homeopathy a fighting chance to show its worth.

There is a downside, of course. There would be a most lamentable mortality rate. But, to paraphrase Dominic Cummings, if a few oldies have to snuff it, so be it!

Once we get used to this innovative approach – I suggest we call it integrative medicine – we might even consider adopting it for other critical situations. When we realise, for instance, that the pension pots are empty, we could officially declare that homeopathy is the ideal medicine for anybody over 60.

What do you think?

 

I have often stated jokingly that ‘HOMEOPATHY IS INCURABLE’; well, I was wrong! There seems to be a treatment that works quite reliably.

It’s called humour.

The Brits have been the pioneers in this field. One of the best examples is this classic by Mitchell and Webb.

 

In my view, it marked a turning point in UK homeopathy. After it’s enormous success, even the NHS re-considered its previously positive stance on homeopathy.

Now, a brilliant French comedian, Jeremy Ferrari, is having a similar success with his homeopathy-show in France. And it too marks the turning point where homeopathy is starting to be phased out from reimbursement in France.

So, are comedians the ones that bring consumers to reason when it comes to absurdities such as homeopathy? Or are comedians gifted at picking up the Zeitgeist and thus merely the ones who hammer the last nail into the coffin of homeopathy?

I think it is probably a bit of both.

But, whatever it is, these guys are brilliant! They achieve more good with their work than others writing clever articles in the Lancet and other medical journals. One good laugh seems to be more efficacious that pages of critical analysis.

If my blog has in the past stimulated some of these comedians to do their ingenious work – and I happen to know it has – I am both delighted and proud.

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