MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bias

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.

A sizeable proportion of the general population is convinced that certain moon phases and moon signs may impact their health as well as the onset and clinical course of diseases. Those who believe in alternative medicine tend, I guess, to belong to this group. Here is a quote from one of the many websites making such claims: Understanding moon cycles and how they affect the body can be a key to better health. To understand how the moon influences your health the first step is to realize that your human body is made up of over 60% water, and the moon affects all water on the Earth.  The moon controls the ebb and flow of the oceanic tides and it controls your human body in the same way.

There is, of course, no plausible reason for such claims and convictions, but this rarely stops the gullible. And anyway, it could be true – or couldn’t it?

This study investigated the perioperative and long-term outcome of living donor kidney transplantation (LDKT) dependent on moon phases and zodiac signs. Patient data were prospectively collected in a continuously updated kidney transplant database. Two hundred and seventy-eight consecutive patients who underwent LDKT between 1994 and December 2009 were selected for the study and retrospectively assigned to the four moon phases (new-moon, waxing-moon, full-moon, and waning-moon) and the corresponding zodiac sign (moon sign Libra), based on the date of transplantation. Pre-existing comorbidities, perioperative mortality, surgical outcome, and long-term survival data were analysed.

Of all LDKT procedures, 11.9; 39.9; 11.5; and 36.5% were performed during the new, waxing, full, and waning moon, respectively, and 6.2% during the moon sign Libra, which is believed to interfere with renal surgery. Survival rates at 1, 5, and 10 years after transplantation were 98.9, 92, and 88.7% (patient survival) and 97.4, 91.6, and 80.6% (graft survival) without any differences between all groups of lunar phases and moon signs. Overall perioperative complications and early graft loss occurred in 21.2 and 1.4%, without statistical difference (p > 0.05) between groups.

The authors concluded that moon phases and the moon sign Libra had no impact on early and long-term outcome measures following LDKT in our study. Thus, concerns of patients awaiting LDKT regarding the ideal time of surgery can be allayed, and surgery may be scheduled independently of the lunar phases.

The authors also concede that their study has some limitations. First, it is a retrospective analysis of a single transplant centre and the number of patients is not huge. In addition, due to the retrospective design of the study, no randomization of the patients was possible. However, a randomization of the patients would systematically ignore the patients preferences. Realization of such a randomized trial would therefore be challenging. As a consequence, we do not know in how many cases the transplant was scheduled according to the lunar phases on the explicit request of the patient. It would be interesting to know whether a strong desire of the patient and a corresponding fulfilment has any influence on the short- and long-term success of the surgery.

Nonsense, I hear the loonies shout: there are numerous studies confirming that the moon has a definite effect on our health!

How do you explain that?

I think there are at least two possible explanations:

  1. these studies were methodologically flawed and lack independent replications;
  2. it cannot be excluded that patients’ fear of the wrong moon-phase might exert a negative influence on their health, irrespective of any influence of the moon. In this case, the moon-phase itself would be irrelevant, but the fear would mimic a real phenomenon.

I recently came across this article; essentially it claims that, in 1918, chiropractic proved itself to be the method of choice for treating the flu!

Unbelievable?

Here is a short quote from it:

Chiropractors got fantastic results from influenza patients while those under medical care died like flies all around. Statistics reflect a most amazing, almost miraculous state of affairs. The medical profession was practically helpless with the flu victims but chiropractors seemed able to do no wrong.”

“In Davenport, Iowa, 50 medical doctors treated 4,953 cases, with 274 deaths. In the same city, 150 chiropractors including students and faculty of the Palmer School of Chiropractic, treated 1,635 cases with only one death.”

“In the state of Iowa, medical doctors treated 93,590 patients, with 6,116 deaths – a loss of one patient out of every 15. In the same state, excluding Davenport, 4,735 patients were treated by chiropractors with a loss of only 6 cases – a loss of one patient out of every 789.

“National figures show that 1,142 chiropractors treated 46,394 patients for influenza during 1918, with a loss of 54 patients – one out of every 886.”

“Reports show that in New York City, during the influenza epidemic of 1918, out of every 10,000 cases medically treated, 950 died; and in every 10,000 pneumonia cases medically treated 6,400 died. These figures are exact, for in that city these are reportable diseases.”

“In the same epidemic, under drugless methods, only 25 patients died of influenza out of every 10,000 cases; and only 100 patients died of pneumonia out of every 10,000 cases…”

“In the same epidemic reports show that chiropractors in Oklahoma treated 3,490 cases of influenza with only 7 deaths. But the best part of this is, in Oklahoma there is a clear record showing that chiropractors were called in 233 cases where medical doctors had cared for the patients, and finally gave them up as lost. The chiropractors saved all these lost cases but 25.”

END OF QUOTE

So what does that sort of ‘evidence’ really show?

Does it prove that chiropractic is effective against influenza?

No!

Does it even suggest that chiropractic is effective against influenza?

No!

What then?

I think it shows that some chiropractors (like many homeopaths) are deluded to a point where they are unable to differentiate pseudoscience from science, anecdote from evidence, cause from effect, etc.

In the case you need more explanations, let me re-phrase this section from a previous post:

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated by chiropractors, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that chiropractic works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless.

The TIMES HIGHER EDUCATION (THE) reported yesterday that the British School of Osteopathy (BSO) has won university college title, meaning that it could be on the road towards full university status. University college title, awarded by the Privy Council on the advice of the Department for Education (DfE) and the Higher Education Funding Council for England, is usually seen as a step towards full university status. The London-based BSO already secured degree-awarding powers and access to Hefce public teaching and research funding in 2015. The BSO will be known, from September, as the University College of Osteopathy.

The THE quoted me saying “Osteopathy is based on implausible assumptions, and there is no good evidence for its effectiveness. Yet osteopaths regularly make all sorts of therapeutic claims. These facts make the BSO not a candidate for becoming a university; on the contrary, such a move would significantly downgrade the credibility of UK universities and make a mockery of academia and evidence-based healthcare.”

Charles Hunt, the BSO principal, responded: “We recognise that for some of the things that some osteopaths are doing, there is very limited evidence [to demonstrate their effectiveness], and we need to gain more for that. But within medicine, there’s a lot of things that also do not have evidence for them, but some medical practitioners are doing [them anyway].”

What???

The BSO principal should offer a course on logical fallacies and enlist as the first student in it, I thought when reading his response.

Anyway, having stated that “osteopaths regularly make all sorts of therapeutic claims”, I better provide some evidence. Perhaps another occasion for a slide-show?

Here are a few images I found on Twitter that are relevant in this context.

[please click to see them full size]

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.

This article could well be proof that homeopathy is ineffective against paranoia.

START OF QUOTE

Given the fact that homeopathy has met with resistance simultaneously on multiple fronts, many are wondering if this is an organized effort. Dr. Larry Malerba, who has practiced homeopathic medicine for more than 25 years, says that he has never witnessed this level of antipathy toward holistic medicine before:

“When one considers the broad array of recent anti-homeopathy activities that cross international borders, it would be naïve to think that there wasn’t a common motivating influence. One has to wonder who stands to gain the most from this witch hunt.”

Homeopathy, in particular, is a thorn in the side of Pharma because of the fact that its unique medicines are FDA regulated, safe, inexpensive, and can’t be patented. Malerba asked the question,

“Could it be that the media is missing the larger story here, that a powerful medical monopoly is seeking to destroy one of its most successful competitors?”

In India, where homeopathy enjoys tremendous popularity, there are an estimated 250 thousand homeopathic practitioners. Indian homeopath, Dr Sreevals G Menon, seems to agree that there is something fishy going on. He recently wrote:

“The renewed and more vigorous attack on the efficacy of homoeopathy as a curative therapy picked up internationally by the media is nothing but a sinister pogrom by the powerful pharmaceutical corporations the world over.” 

… Homeopathic supporters have long suspected that Pharma is secretly funding skeptic organizations. It appears that Pharma astroturfs by taking advantage of skeptic organizations that have strong anti-holistic medicine beliefs, encouraging them to spread false information about homeopathy.

But questions remain. Does this constitute an anti-democratic assault on freedom of medical choice? Are media outlets that have been manipulated by corporate medical interests feeding false information to consumers? Why is an increasingly popular medical therapy known for its long track record of safety suddenly receiving so much negative attention?…

END OF QUOTE

I do sympathize with those poor homeopathy fans!

Paranoia is a nasty condition!

And their placebos are useless for alleviating it.

Sad – really sad.

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.

Someone alerted me to this article – and I was delighted, of course:

While social media might feel at times like it is all about food, fashion and celebrities, there can be much more to it than that. You can transform your feeds into places of scientific discovery, if you just follow the right people.

WIRED has put together a list of the best scientists to follow on Twitter and Instagram to make your feeds more informed places.

The article then lists 11 blogs and includes mine!!! Here is the short entry about it:

Edzard Ernst

Chair in Complementary Medicine at the University of Exeter, Ernst has studied the evidence, or lack of, towards alternative medicine for 25 years. “My goal is to provide objective evidence and reliable information,” he says on his blog. “This ambition did not endear me to many believers in alternative medicine.” Follow him for strong opinions (based on facts) and heated arguments.

Such praise is great!

But I must not forget that I also get criticism – lots of it.

Often I am accused of no posting balanced views. This is not scientific, my detractors claim.

I do think about criticism quite a bit – some of it is justified, of course, but this particular point puzzles me.

Let me explain.

A blog is very different from a scientific paper. A blog is “a regularly updated website or web page, typically one run by an individual or small group, that is written in an informal or conversational style.” When I write a blog, I am trying to be a decent journalist.

A scientific paper is “is a written and published report describing original research results.” When I write a scientific paper, I am trying to be a decent scientist.

I have published plenty of blog-posts and even more scientific articles; when I do a scientific paper, I aim at being balanced, objective, cautious, systematic, etc. I (typically together with several co-authors) work on such an article for months, revise and re-revise it many times. I get it peer-reviewed and change it according to the ideas of the peer-reviewers.

Hardly any of this happens when I write a blog. It is done quickly in hours, not months, it therefore might even contain a few errors (for which I apologise), it is often aimed at provoking discussions and debates, it uses language that I would not dream of employing in a scientific paper. My blog-posts are rarely aimed at expressing a balanced view; they are mostly about my spontaneous criticism of, or amazement about something I came across in the last day or so.

While all of this is totally obvious to me, I now realise that it is not nearly as clear to those who are novices to science and research, or those who never have read or published a scientific article. So, let’s be clear: if you want to criticise my posts, please do so – I always try to learn from constructive criticism. But please try to understand that this blog is not the place where I publish scientific papers. Please avoid criticising a banana for failing to taste like an orange.

 

This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:

  1. low frequency manual acupuncture (LF-MA),
  2. high frequency manual acupuncture (HF-MA),
  3. low frequency electro acupuncture (LF-EA)
  4. and high frequency electro acupuncture (HF-EA).

A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.

During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.

The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.

Let me explain:

  • acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
  • the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
  • acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?

The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.

Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.

This recently published report provides updated clinical practice guidelines from the Society for Integrative Oncology on the use of integrative therapies for specific clinical indications during and after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue, quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphedema, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance.

The practice guidelines are based on a systematic literature review from 1990 through 2015. The recommendations are as follows:

  • Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction.
  • Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders.
  • Meditation and yoga are recommended to improve quality of life.
  • Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting.
  • Acetyl-L-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy due to a possibility of harm.
  • No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment-related side effects.

The authors conclude that there is a growing body of evidence supporting the use of integrative therapies, especially mind-body therapies, as effective supportive care strategies during breast cancer treatment. Many integrative practices, however, remain understudied, with insufficient evidence to be definitively recommended or avoided.

I have to admit that I am puzzled by this paper.

The first obvious point to make is that these treatments are not ‘integrative therapies’; they are alternative or complementary and I fail to see what is integrative about them.

The second point is that the positive recommendations are based on often poor-quality studies which did not control for placebo effects.

The third point is that the negative recommendations are woefully incomplete. There are many more alternative therapies for which there is no strong evidence.

The forth point is the conclusion implying that treatment supported by insufficient evidence should be avoided. I would not claim that any of the mentioned treatments is backed by SUFFICIENT evidence. Therefore, we should avoid them all, one might argue.

But these concerns are perhaps relatively trivial or far-fetched. More important is the fact that a very similar article been published in 2014. Here is the abstract:

Background

The majority of breast cancer patients use complementary and/or integrative therapies during and beyond cancer treatment to manage symptoms, prevent toxicities, and improve quality of life. Practice guidelines are needed to inform clinicians and patients about safe and effective therapies.

Methods

Following the Institute of Medicine’s guideline development process, a systematic review identified randomized controlled trials testing the use of integrative therapies for supportive care in patients receiving breast cancer treatment. Trials were included if the majority of participants had breast cancer and/or breast cancer patient results were reported separately, and outcomes were clinically relevant. Recommendations were organized by outcome and graded based upon a modified version of the US Preventive Services Task Force grading system.

Results

The search (January 1, 1990–December 31, 2013) identified 4900 articles, of which 203 were eligible for analysis. Meditation, yoga, and relaxation with imagery are recommended for routine use for common conditions, including anxiety and mood disorders (Grade A). Stress management, yoga, massage, music therapy, energy conservation, and meditation are recommended for stress reduction, anxiety, depression, fatigue, and quality of life (Grade B). Many interventions (n = 32) had weaker evidence of benefit (Grade C). Some interventions (n = 7) were deemed unlikely to provide any benefit (Grade D). Notably, only one intervention, acetyl-l-carnitine for the prevention of taxane-induced neuropathy, was identified as likely harmful (Grade H) as it was found to increase neuropathy. The majority of intervention/modality combinations (n = 138) did not have sufficient evidence to form specific recommendations (Grade I).

Conclusions

Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment. Most integrative therapies require further investigation via well-designed controlled trials with meaningful outcomes.

I have harshly criticised this review on this blog in 2016. For instance, I voiced concern about the authors declaration of conflicts of interest and stated:

 

I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine

The just-published update has a different statement about conflicts of interest:

DISCLOSURES: Linda E. Carlson reports book royalties from New Harbinger and the American Psychological Association. Misha R. Cohen reports royalties from Health Concerns Inc., outside the submitted work. Matthew Mumber owns stock in I Thrive. All remaining authors report no conflicts of interest.

Is this much better than the previous statement? Was the previous statement therefore false?

I wonder.

What do you think?

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