MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

scientific misconduct

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If you had chronic kidney disease (CKD), would you be attracted by an article entitled ‘How to Reduce Creatinine Level in Homeopathy’? (Elevated levels are normally caused by CKD which makes it an important diagnostic test to diagnose the condition) I am sure many patients would! A few days ago, an article with exactly this title caught my eye; it comes from this website. I find it remarkable and cannot resist showing you a short excerpt from it:

START OF QUOTE

…These [homeopathic] medicines work in two ways. First of all, they control the condition so that no more damage is done to the kidneys. Secondly, they start elimination the root causes of renal failure. Unlike allopathic medicines, there are no side effects associated with the use of Homeopathic medicines. If treatment is done in a right, patients starts feeling better within few weeks. After few months, most of the patients are recovered and their kidney starts functioning properly and normally. And then your creatinine level will come down…

Toxin-Removing Treatment for patients with high creatinine level

Here we recommend you another treatment. It is Toxin-Removing Treatment, which is a combination of various Chinese medicine. Compared with homeopathy, Chinese medicine has a particularly longer history. It can expel waste products and extra fluid out of body to make internal environment good for kidney self-healing and other medication application. It can also dilate blood vessels and remove stasis to improve blood circulation and increase blood flow into damaged kidneys so that enough essential elements can be transported into damaged kidneys to speed up kidney recovery. Besides, it can strengthen your immunity to fight against kidney disease. After about one week’s treatment, you will see floccules in urine, which are wastes being passed out. After about half month’s treatment, your high creatinine, high BUN and high uric acid level will go down. After about one month’s treatment, your kidney function will start to increase. With the improvement of renal function, creatinine can be excreted out naturally.

END OF QUOTE

After reading this article some CKD patients might decide to try homeopathy or Chinese Herbal Medicine (CHM) for their condition. This, however, would be very ill-advised.

Why?

Because there is not a jot of evidence to suggest that homeopathy works for CKD. If any homeopath reading this has a different opinion, please show us the evidence.

There is also, as far as I can see, little good evidence to suggest that CHM is effective for CKD. On the contrary, there is quite a bit of evidence to show that CHM can cause kidney damage.

So?

The above article is misleading to the extreme! Or, to put it bluntly, it’s full of lies.

But why is this remarkable? On the Internet, we find thousands of similarly idiotic texts promoting bogus treatments for every disease known to mankind – and nobody seems to bat an eyelash about it. Nobody seems to think that the public needs to be better protected from the habitual liars who write such vile stuff. Many influential people and institutions not merely tolerate such abuse but seem to support it.

Precisely … and this is why I find this article, together with the thousands of similar ones, remarkable.

 

 

Reiki has been on my mind repeatedly (see for instance here, here, here and here). It is one of those treatments that are too crazy for words and too implausible to mention. Yet a new paper firmly claims that it is more than a placebo.

This review evaluated clinical studies of Reiki to determine whether there is evidence for Reiki providing more than just a placebo effect. The available English-language literature of Reiki was reviewed, specifically for

  • peer-reviewed clinical studies,
  • studies with more than 20 participants in the Reiki treatment arm,
  • studies controlling for a placebo effect.

Of the 13 suitable studies,

  • 8 demonstrated Reiki being more effective than placebo,
  • 4 found no difference but had questionable statistical resolving power,
  • one provided clear evidence for not providing benefit.

The author concluded that these studies provide reasonably strong support for Reiki being more effective than placebo. From the information currently available, Reiki is a safe and gentle “complementary” therapy that activates the parasympathetic nervous system to heal body and mind. It has potential for broader use in management of chronic health conditions, and possibly in postoperative recovery. Research is needed to optimize the delivery of Reiki.

These are truly fantastic findings! Reiki is more than a placebo – would have thought so? Who would have predicted that something as implausible as Reiki would one day be shown to work?

Now let’s start re-writing the textbooks of physics and therapeutics and research how we can optimize the delivery of Reiki.

Hold on – not so quick! Here are a few reasons why we might be sceptical about the validity of this review:

  • It was published in one of the worst journals of alternative medicine.
  • The author claimed to include just clinical trials but ended up including non-clinical studies and animal studies.
  • Four trials were not double-blind.
  • There was no critical assessment of the studies methodological quality.
  • The many flaws of the primary studies were not mentioned in this review.
  • Papers not published in English were omitted.
  • The author who declared no conflict of interest has this affiliation: “Australasian Usui Reiki Association, Oakleigh, Victoria, Australia”.

I think we can postpone the re-writing of textbooks for a little while yet.

The claims that are being made for the health benefits of Chinese herbal medicine are impressive. I am not sure that there is even a single human disease that is not alleged to be curable with the use of some Chinese herbal mixture. I find this worrying because some patients might actually believe such outrageous nonsense, particularly since Chinese researchers seem to bend over backwards to support them with science… or should I say pseudoscience?

This study was aimed at evaluating the association between mortality rate and early use of Chinese herbal products (CHPs) among patients with lung cancer. The researchers conducted a retrospective cohort study based on the National Health Insurance Research Database, Taiwan Cancer Registry, and Cause of Death Data. Patients with newly diagnosed lung cancer between 2002 and 2010 were classified as either the CHP (n = 422) or the non-CHP group (n = 2828) based on whether they used CHP within 3 months after first diagnosis of lung cancer. A Cox regression model was used to examine the hazard ratio (HR) of death for propensity score (PS) matching samples.

After PS matching, average survival time of the CHP group was significantly longer than that of the non-CHP group. The adjusted HR (0.82; 95% CI: 0.73-0.92) in the CHP group was lower than the non-CHP group. Stratified by clinical cancer stages, CHP group had longer survival time in the stage 3 subgroup. When the exposure period of CHP use was changed from 3 to 6 months, results remained similar.

The authors concluded that results indicated that patients with lung cancer who used CHP within 3 months after first diagnosis had a lower hazard of death than non-CHP users, especially for stage 3 lung cancer. Further experimental studies are needed to examine the causal relationship.

I would argue the direct opposite: further studies along these lines would be a waste of time!

I can name numerous reasons for this, for example:

  • Investigating CHP as though it is one entity is nonsense. There are thousands of different CHPs; some are placebos; some are toxic; and a few might even have some health effects.
  • The observed effect is almost certainly an artefact; the matching of the groups might have been sub-optimal; the CHP group differed systematically from the control group, for instance, by adhering to a healthier life-style; etc, etc.

All of this should be so obvious that it hardly deserves a mention. Why then do the authors not point it out prominently and clearly? Why did they ever embark on such a fatally flawed project? I cannot be sure, of course, … but perhaps one possible answer might be that the lead author is affiliated to a Department of Chinese Medicine?

 

The goal of this study was to assess clinical outcomes observed among adult patients who received acupuncture treatments at a United States Air Force medical center.

This retrospective chart review was performed at the Nellis Family Medicine Residency in the Mike O’Callaghan Military Medical Center at Nellis Air Force Base in Las Vegas, NV. The charts were from 172 consecutive patients who had at least 4 acupuncture treatments within 1 year. These patients were suffering from a wide range of symptoms, including pain, anxiety and sleep problems. The main outcome measures were prescriptions for opioid medications, muscle relaxants, benzodiazepines, and nonsteroidal anti-inflammatory drugs (NSAIDS) in the 60 days prior to the first acupuncture session and in the corresponding 60 days 1 year later; and Measure Yourself Medical Outcome Profile (MYMOP2) values for symptoms, ability to perform activities, and quality of life.

The most common 10 acupuncture treatments in descending order were: (1) the Auricular Trauma Protocol; (2) Battlefield Auricular Acupuncture; (3) Chinese scalp acupuncture, using the upper one-fifth of the sensory area and the Foot Motor Sensory Area; (4) the Koffman Cocktail; (5) lumbar percutaneous electrical nerve stimulation (PENS); (6) various auricular functional points; (7) Chinese scalp acupuncture, using the frontal triangle pattern; (8) cervical PENS; (9) the Great American Malady treatment; and (10) tendinomuscular meridian treatment with surface release.

The results show that opioid prescriptions decreased by 45%, muscle relaxants by 34%, NSAIDs by 42%, and benzodiazepines by 14%. MYMOP2 values decreased 3.50–3.11 (P < 0.002) for question 1, 4.18–3.46 (P < 0.00001) for question 3, and 2.73–2.43 (P < 0.006) for question 4.

The authors concluded that in this military patient population, the number of opioid prescriptions decreased and patients reported improved symptom control, ability to function, and sense of well-being after receiving courses of acupuncture by their primary care physicians.

The phraseology used by the authors is intriguing; they imply that the clinical outcomes were the result of the acupuncture treatment without actually stating it. This is perhaps most obvious in the title of the paper: Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Association is not causation! But the implication of a cause effect relationship is clearly there. Once we realise who is behind this research we understand why: This study was funded by the ACUS Foundation as part of a Cooperative Research and Development Agreement with the 99th Medical Group, at Nellis Air Force Base. 

The mission of Acus Foundation is to educate military physicians in the science and art of medical acupuncture, and to facilitate its integration into conventional military care… we are the most experienced team of physician teachers and practitioners of acupuncture in the United States. If they are so experienced, they surely also know that there are many explanations for the observed outcomes which are totally unrelated to acupuncture, e. g.:

  • the natural history of the conditions that were being treated;
  • the conventional therapies the soldiers received;
  • the regression to the mean;
  • social desirability;
  • placebo effects.

In fact the results could even indicate that acupuncture caused a delay of clinical improvement; without a control group, we cannot know either way. All we can safely assume from this study is that it is yet another example of promotion masquerading as research.

The UK ‘Faculty of Homeopathy’ (FoH) is the professional body of British doctors who specialise in homeopathy. As doctors, FoH members have been to medical school and should know about evidence, science etc., I had always thought. But perhaps I was mistaken?

The FoH has a website with an interesting new post entitled ‘Scientific evidence and Homeopathy’. Here I have copied the section on CLINICAL TRIALS OF HOMEOPATHY. I have read it several times and must admit: it is a masterpiece, in my view – not a masterpiece in accurate reporting, but a masterpiece in misleading the public. The first and most obvious thing that struck me is the fact that is cites not a single clinical trial. But read for yourself (the numbers in round brackets were inserted by me and refer to my comments below):

START OF QUOTE

By August 2017 1,138 clinical trials of homeopathy had been published (1). Details can be found on the CORE-HOM database also maintained by the Carstens Foundation and accessible without charge: http://archiv.carstens-stiftung.de/core-hom

Four (2) systematic review/meta-analyses of homeopathy for all conditions have been published.[26],[27],[28]  Of these, three (3) reached a positive conclusion: that there is evidence that homeopathy is clinically effective (4). The exception is the review by Shang et al.46  This meta-analysis was controversial, particularly because its conclusions were based on only eight clinical trials whose identity was concealed until several months after the publication, precluding informed examination of its results (5) (6). The only undisputed conclusion (7) of this paper is that clinical trials of homeopathy are of higher quality than matched trials of conventional medicine: of 110 clinical trials each of homeopathy and conventional medicine, 21 trials of homeopathy but only 9 trials of conventional medicine were of ‘higher quality’.[29] [30]

A leading Swedish medical researcher (8) remarked: To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be dis­regarded.  Alternatively, flawed statistical methods had to be applied.”[31] Higher quality equates to less risk of bias, Mathie et al analysed randomized clinical trials of individualized homeopathy, showing that the highest quality trials yielded positive results (9).[32]

Systematic reviews of randomized controlled trials of homeopathy in specific clinical situations have also yielded positive results, including: allergies and upper respiratory tract infections (2 systematic reviews),[33],[34] (10) (11) Arnica in knee surgery,[35] (12) Childhood diarrhoea,[36] Post-operative ileus,[37] (13) Rheumatic diseases,[38] (14) Seasonal allergic rhinitis (hay fever) (2 systematic reviews),[39] [40] (15) (16) and vertigo.[41] (17)

END OF QUOTE

MY COMMENTS:

  1. This is a wild exaggeration which was made possible by counting all sorts of clinical reports as ‘clinical trials’. A clinical trial  “follows a pre-defined plan or protocol to evaluate the effects of a medical or behavioral intervention on health outcomes.” This would exclude most observational studies, case series, case reports. However, the figure cited here includes such reports.
  2. The author cites only three!
  3. Does the author mean ‘two’?
  4. This is not quite true! I have dedicated an entire post to this issue.
  5. True, the Shang meta-analysis has been criticised – but exclusively by homeopaths who, for obvious reasons, were unable to accept its negative findings. In fact, it is a solid piece of research.
  6. Why does the author not mention the most recent systematic review of homeopathy?  Perhaps because it concluded: Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
  7. Really? Undisputed? Even by the logic of the author’s last sentence, this would be disputed.
  8. The ‘leading researcher’ is Prof Hahn who has featured many times on my blog. He seems to be more than a little unhinged when it comes to the topic of homeopathy.
  9. The author forgot to mention that Mathie – who was sponsored by the British Homeopathic Association – included this little caveat in his conclusions: The low or unclear overall quality of the evidence prompts caution in interpreting the findings.
  10. Reference 33 is the infamous ‘Swiss report’ that has been shown to be fatally flawed over and over again.
  11. Reference 34 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  12. This review concluded: In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial. Only a deluded homeopath can call this a ‘positive result’.
  13. This is a systematic review by my team. It showed that several flawed trials produced a false positive result, while the only large multicentre trial was negative. Our conclusions therefore include the statement that  several caveats preclude a definitive judgment. Only a deluded homeopath can call this a ‘positive result’.
  14. This reference refers to the following abstract: Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide. Only a deluded homeopath can call this a ‘positive result’.
  15. The first reference refers to a paper where the author analysed three of his own studies.
  16. Reference 40 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  17. This reference refers to a review of Vertigoheel@ that includes observational studies. One of its authors was an employee of the manufacturer of the product. Vertigoheel is not a homeopathic remedy (it does not adhere to the ‘like cures like’ principle) but a homotoxicologic product. Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel. Our own systematic review of RCTs of homotoxicology included 7 trials which were mostly of a high methodological standard, according to the Jadad score. The trials tested the efficacy of seven different medicines for seven different indications. The results were positive in all but one study. Important flaws were found in all trials. These render the results of the primary studies less reliable than their high Jadad scores might suggest. Despite mostly positive findings and high ratings on the Jadad score, the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.

So!

What do we make of all this?

To say that it is disappointing would, I think, be an understatement. The FoH is not supposed to be a lobby group of amateurs ignorant of science and evidence; it is a recognised professional organisation who must behave ethically. Patients and consumers should be able to trust the FoH. The fact that the FoH publish misinformation on such a scale should, in my view, be a matter for the General Medical Council.

I just came across a new article entitled ” Vaccinated children four times more likely to suffer from ADHD, autism“. It was published in WDDTY, my favourite source of misleading information. Here it is:

Vaccinated children are nearly four times more likely to suffer from learning disabilities, ADHD and autism, a major new study has discovered—and they are six times more likely to suffer from one of these neuro-developmental problems if they were also born prematurely.

The vaccinated child is also more likely to suffer from otitis media, the ear infection, and nearly six times more likely to contract pneumonia.

But the standard childhood vaccines do at least do their job: the vaccinated child is nearly eight times less likely than the unvaccinated to develop chicken pox, and also less likely to suffer from whooping cough (pertussis).

Researchers from Jackson State University are some of the first to look at the long-term effects of vaccination. They monitored the health of 666 children for six years from the time they were six—when the full vaccination programme had been completed—until they were 12. All the children were being home-schooled because it was one of the few communities where researchers could find enough unvaccinated children for comparison; 261 of the children hadn’t been vaccinated and 208 hadn’t had all their vaccinations, while 197 had received the full 48-dose course.

The vaccinated were more likely to suffer from allergic rhinitis, such as hay fever, eczema and atopic dermatitis, learning disability, ADHD (attention-deficit, hyperactive disorder), and autism. The risk was lower among the children who had been partially vaccinated.

Vaccinated children were also more likely to have taken medication, such as an antibiotic, or treatment for allergies or for a fever, than the unvaccinated.

END OF QUOTE

I looked up the original study to check and found several surprises.

The first surprise was that the study was called a ‘pilot’ by its authors, even in the title of the paper: “Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children.”

The second surprise was that even the authors admit to important limitations of their research:

We did not set out to test a specific hypothesis about the association between vaccination and health. The aim of the study was to determine whether the health outcomes of vaccinated children differed from those of unvaccinated homeschool children, given that vaccines have nonspecific effects on morbidity and mortality in addition to protecting against targeted pathogens [11]. Comparisons were based on mothers’ reports of pregnancy-related factors, birth histories, vaccinations, physician-diagnosed illnesses, medications, and the use of health services. We tested the null hypothesis of no difference in outcomes using chi-square tests, and then used Odds Ratios and 96% Confidence Intervals to determine the strength and significance of the association…

What credence can be given to the findings? This study was not intended to be based on a representative sample of homeschool children but on a convenience sample of sufficient size to test for significant differences in outcomes. Homeschoolers were targeted for the study because their vaccination completion rates are lower than those of children in the general population. In this respect our pilot survey was successful, since data were available on 261 unvaccinated children…

Mothers’ reports could not be validated by clinical records because the survey was designed to be anonymous. However, self-reports about significant events provide a valid proxy for official records when medical records and administrative data are unavailable [70]. Had mothers been asked to provide copies of their children’s medical records it would no longer have been an anonymous study and would have resulted in few completed questionnaires. We were advised by homeschool leaders that recruitment efforts would have been unsuccessful had we insisted on obtaining the children’s medical records as a requirement for participating in the study.

A further potential limitation is under-ascertainment of disease in unvaccinated children. Could the unvaccinated have artificially reduced rates of illness because they are seen less often by physicians and would therefore have been less likely to be diagnosed with a disease? The vaccinated were indeed more likely to have seen a doctor for a routine checkup in the past 12 months (57.5% vs. 37.1%, p < 0.001; OR 2.3, 95% CI: 1.7, 3.1). Such visits usually involve vaccinations, which nonvaccinating families would be expected to refuse. However, fewer visits to physicians would not necessarily mean that unvaccinated children are less likely to be seen by a physician if their condition warranted it. In fact, since unvaccinated children were more likely to be diagnosed with chickenpox and whooping cough, which would have involved a visit to the pediatrician, differences in health outcomes are unlikely to be due to under-ascertainment.

The third surprise was that the authors were not at all as certain as WDDTY in their conclusions: “the study findings should be interpreted with caution. First, additional research is needed to replicate the findings in studies with larger samples and stronger research designs. Second, subject to replication, potentially detrimental factors associated with the vaccination schedule should be identified and addressed and underlying mechanisms better understood. Such studies are essential in order to optimize the impact of vaccination of children’s health.”

The fourth surprise was to find the sponsors of this research:

Generation Rescue is, according to Wikipedia, a nonprofit organization that advocates the incorrect view that autism and related disorders are primarily caused by environmental factors, particularly vaccines. These claims are biologically implausible and are disproven by scientific evidence. The organization was established in 2005 by Lisa and J.B. Handley. They have gained attention through use of a media campaign, including full page ads in the New York Times and USA Today. Today, Generation Rescue is known as a platform for Jenny McCarthy‘s autism and anti-vaccine advocacy.

The Children’s Medical Safety Research Institute (CMSRI) was, according to Vaxopedia, created by and is funded by the Dwoskin Family Foundation. It provides grants to folks who will do research on “vaccine induced brain and immune dysfunction” and on what they believe are other “gaps in our knowledge about vaccines and vaccine safety”, including:

While they claim that they are not an anti-vaccine organization, it should be noted that  Claire Dwoskin once said that “Vaccines are a holocaust of poison on our children’s brains and immune systems.”

Did I say SURPRISE?

I take it back!

When it comes to WDDTY, nothing does surprise me.

To a significant extend, this blog has always exposed untruths in the realm of alternative medicine – not just one or two, but hundreds. Obviously, some of them are more clear-cut than others. If, for instance, someone claims that acupuncture has been proven to be effective for a given condition, this many seem like a lie or untruth to you, like a misinterpretation of the evidence to someone else, or like the truth to a third person.

But there are some statements which are demonstrably false. These are often the most irritating lies, frequently forwarded by people who should know better and who nevertheless insist on not being truthful. Below I have listed a few, randomly-chosen examples upon which I have previously commented. For clarity, I have copied the quotes in question, linked them to my original posts, named the authors in brackets, and added a brief comment by myself in bold print.

I was at Exeter when Ernst took over what was already a successful Chair in CAM. (anonymous reviewer of my book at Amazon)

Anyone can check this fairly easily, for instance, in my memoir ‘A SCIENTIST IN WONDERLAND’, there was no pre-existing chair at Exeter.

Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), (Dr Peter Fisher, homeopath of the Queen)

This was painfully investigated during a 13 (!) months inquiry which found that I did not leak this report. Again you find the full details in my memoir.

…homeopathic care is recommended for people who have been exposed (or think they have been exposed) to toxic substances… (Dana Ullman US homeopath)

As far as this statement implies that homeopathy is effective for treating intoxications, this is not only a lie but a very dangerous nonsense.

Homeopathy has a long history of being used successfully in veterinary practice for both domestic and farm animals. (UK Faculty of Homeopathy)

If this is to suggest that homeopathy is of proven effectiveness in treating diseases of animals, this is a lie.

Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes. (Lisa is the mastermind behind All Natural Ideas)

Homeoprophylaxis has never been proven to prevent any disease; this lie could kill millions.

There are essentially two categories of critics. The first category consists of individuals who are totally ignorant of homeopathy and just repeating propaganda they’ve been exposed to. The second category is people who know that homeopathy works, but have a vested financial interest in destroying it. (Alan Schmukler, US homeopathy)

This lie is quite funny in its transparent defamation of the truth, I think.

Homeopathy works like a vaccine. (Dr Batra, Indian homeopath)

Homeopathy does not even remotely work like a vaccine; in fact, it works like a placebo, if at all.

…UK invests 0% of its research budget on CAM… (Dr Michael Dixon, GP and advisor to Prince Charles)

There has always been a sizable budget for CAM-research in the UK.

Even cancer viruses have, on record, been put into vaccinations. There is no actual vaccine for cancer. The only reason to put cancer viruses in the mix is to create more cases of cancer. In this day and age, one of the most dangerous things you can do for your health is to get vaccinated… (US homeopath)

In this short quote, there are more lies than I care to comment on. The paranoia of the anti-vaccination brigade is astounding and endangers many lives.

A lie is a statement used intentionally for the purpose of deception. In alternative medicine, we encounter so many lies that one would need to continually publish volume after volume to expose just the most harmful untruths. The danger of these lies is that some people might believe them. This could seriously harm their health. Another danger is that we might get used to them, trivialise them, or – like Trump and co – start thinking of them as ‘alternative facts’.

I will continue to do my best to prevent any of this from happening.

 

I have repeatedly cautioned about the often poor quality of research into alternative medicine. This seems particularly necessary with studies of acupuncture, and especially true for such research carried out in China. I have also frequently noted that certain ‘CAM journals’ are notoriously prone to publishing rubbish. So, what can we expect from a paper that:

  • is on alternative medicine,
  • focusses on acupuncture,
  • is authored by Chinese researchers,
  • was published in the Journal of Alternative and Complementary Medicine (JACM)?

The answer is PROBABLY NOT A LOT!

As if for confirming my prediction, The JACM just published this systematic review. It reports pairwise and network meta-analyses to determine the effectiveness of acupuncture and acupuncture-related techniques for the treatment of psoriasis. A total of 13 RCTs were included. The methodological quality of these studies was ‘not rigorous’ according to the authors – in fact, it was lousy. Acupoint stimulation seemed to be more effective than non-acupoint stimulation. The short-term treatment effect was superior to the long-term effect (as one would expect with placebo). Network meta-analysis suggested that acupressure or acupoint catgut embedding generate superior effects compared to medications. It was noted that acupressure was the most effective treatment of all the acupuncture-like therapies.

The authors concluded that acupuncture-related techniques could be considered as an alternative or adjuvant therapy for psoriasis in short term, especially of acupressure and acupoint catgut embedding. This study recommends further well-designed, methodologically rigorous, and more head-to-head randomized trials to explore the effects of acupuncture-related techniques for treating psoriasis.

And what is wrong with that?

EVERYTHING!

  • The review is of very poor quality.
  • The primary studies are even worse.
  • The English language is defective to the point of being not understandable.
  • The conclusions are misleading.

Correct conclusions should read something like this: Due to the paucity and the poor quality of the clinical trials, this review could not determine whether acupuncture and similar therapies are effective for psoriasis.

And then there is, of course, the question about plausibility. How plausible is the assumption that acupuncture might affect a genetic autoimmune disease like psoriasis. The answer, I think, is that the assumption is highly unlikely.

In the above review, most of the 13 primary RCTs were from China. One of the few studies not conducted in China is this one:

56 patients suffering from long-standing plaque psoriasis were randomized to receive either active treatment (electrostimulation by needles placed intramuscularly, plus ear-acupuncture) or placebo (sham, ‘minimal acupuncture‘) twice weekly for 10 weeks. The severity of the skin lesions was scored (PASI) before, during, and 3 months after therapy. After 10 weeks of treatment the PASI mean value had decreased from 9.6 to 8.3 in the ‘active’ group and from 9.2 to 6.9 in the placebo group (p < 0.05 for both groups). These effects are less than the usual placebo effect of about 30%. There were no statistically significant differences between the outcomes in the two groups during or 3 months after therapy. The patient’s own opinion about the results showed no preference for ‘active’ therapy. It was also clear from the answers that the blinded nature of the study had not been discovered by the patients. In conclusion, classical acupuncture is not superior to sham (placebo) ‘minimal acupuncture‘ in the treatment of psoriasis.

Somehow, I trust these conclusions more than the ones from the review!

And somehow, I get very tired of journal editors failing to do their job of rejecting papers that evidently are embarrassing, unethical rubbish.

Systematic reviews are aimed at summarising and critically evaluating the evidence on a specific research question. They are the highest level of evidence and are more reliable than anything else we have. Therefore, they represent a most useful tool for both clinicians and researchers.

But there are, of course, exceptions. Take, for instance, this recent systematic review by researchers from the

  • Texas Chiropractic College, Pasadena, the Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport,
  • Department of Planning, Policy and Design, University of California, Irvine,
  • VA Puget Sound Health Care System, Tacoma,
  • New York Chiropractic College, Seneca Falls,
  • Logan University College of Chiropractic, Chesterfield,
  • University of Western States, Portland.

Its purpose was to evaluate the effectiveness of conservative non-drug, non-surgical interventions, either alone or in combination, for conditions of the shoulder. The review was conducted from March 2016 to November 2016 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), and was registered with PROSPERO. Eligibility criteria included randomized controlled trials (RCTs), systematic reviews, or meta-analyses studying adult patients with a shoulder diagnosis. Interventions qualified if they did not involve prescription medication or surgical procedures, although these could be used in the comparison group or groups. At least 2 independent reviewers assessed the quality of each study using the Scottish Intercollegiate Guidelines Network checklists. Shoulder conditions addressed were

  • shoulder impingement syndrome (SIS),
  • rotator cuff-associated disorders (RCs),
  • adhesive capsulitis (AC),
  • nonspecific shoulder pain.

Twenty-five systematic reviews and 44 RCTs met inclusion criteria. Low- to moderate-quality evidence supported the use of manual therapies for all 4 shoulder conditions. Exercise, particularly combined with physical therapy protocols, was beneficial for SIS and AC. For SIS, moderate evidence supported several passive modalities. For RC, physical therapy protocols were found beneficial but not superior to surgery in the long term. Moderate evidence supported extracorporeal shockwave therapy for calcific tendinitis RC. Low-level laser was the only modality for which there was moderate evidence supporting its use for all 4 conditions.

The authors concluded that the findings of this literature review may help inform practitioners who use conservative methods (eg, doctors of chiropractic, physical therapists, and other manual therapists) regarding the levels of evidence for modalities used for common shoulder conditions.

This review has so many defects that it would be boring to list them here.

The PRISMA guidelines  – I happen to be a co-author – state, for instance, that the abstract (the above text is from the abstract) should provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number. It is obvious that the review authors have omitted several of these items.

And that is just the abstract!  There is much, much more to criticise in this paper.

The most striking deficit, in my view, is the useless conclusion: the one from the abstract (the part of the paper that will be read most widely) could have been written before the review had even been started. It is therefore not based on the data presented. Crucially it does not match the stated aim of this review (“to evaluate the effectiveness of conservative…interventions”).

But why? Why did the authors bother to follow PRISMA? Why did they formulate this bizarre conclusion in their abstract? Why did they do a review in the first place?

I fear, the answers might be embarrassingly simple:

  • They only pretended to follow PRISMA guidelines because that gives their review a veneer of respectability.
  • They formulated the conclusions because otherwise they would have needed to state that the evidence for manual therapy is less than convincing.
  • They conducted the review to promote chiropractic, and when the data were not as they had hoped for, they just back-paddled in an attempt to hide the truth as much as possible.

If this were an isolated case, I would not have bothered to mention it. But sadly, in the realm of chiropractic (and alternative medicine in general) we currently witness a plethora of rubbish reviews (published by rubbish journals). To the naïve observer, they might look rigorous and therefore they will be taken seriously. The end-effect of this pollution of the literature with rubbish is that we get a false-positive impression about the validity of the treatments in question. Consequently, we will see a host of wrong decisions on all levels of healthcare.

The big question is: HOW DO WE PROTECT OURSELVES FROM THIS DANGEROUS TREND?

I only see one solution: completely disregard certain journals that have been identified to regularly publish nonsense. Sadly, the wider medical community is far from having arrived at this point. As far as I can see, the problem has not even been identified yet as a serious issue that needs addressing. For the foreseeable future, we will probably have to live with this type of pollution of our medical literature.

How often have I pointed out that most studies of chiropractic (and other alternative therapies) are overtly unethical because they fail to report adverse events? And if you think this is merely my opinion, you are mistaken. This new analysis by a team of chiropractors aimed to describe the extent of adverse events reporting in published RCTs of Spinal Manipulative Therapy (SMT), and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.

The Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analysed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analysed using tests for equality of proportions with continuity correction.

Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.

The authors concluded that although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.

We conducted a very similar analysis back in 2012. Specifically, we evaluated all 60 RCTs of chiropractic SMT published between 2000 and 2011 and found that 29 of them did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred (which I find hard to believe since reliable data show that about 50% of patients experience adverse effects after consulting a chiropractor). Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors. Our conclusion was that adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The new paper suggests that the situation has improved a little, yet it is still wholly unacceptable. To conduct a clinical trial and fail to mention adverse effects is not, as the authors of the new article suggest, against current guidelines; it is a clear and flagrant violation of medical ethics. I blame the authors of such papers, the reviewers and the journal editors for behaving dishonourably and urge them to get their act together.

The effects of such non-reporting are obvious: anyone looking at the evidence (for instance via systematic reviews) will get a false-positive impression of the safety of SMT. Consequently, chiropractors are able to claim that very few adverse effects have been reported in the literature, therefore our hallmark therapy SMT is demonstrably safe. Those who claim otherwise are quite simply alarmist.

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