MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

conflict of interest

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?

 

It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?

As with any gift, one ought to ask what precisely it is for. If someone made a donation to research aimed at showing that climate change is a hoax, that white supremacy is justified, or that Brexit is going to give Brits their country back, I doubt that it would be a commendable thing. My point is that research must always be aimed at finding the truth and discovering facts. Research that is guided by creed, belief or misinformation is bound to be counter-productive, and a donation to such activities is likely to be detrimental.

Back to the Samuelis! The story goes that Susan once had a cold, took a homeopathic remedy, and subsequently the cold went away. Ever since, the two Samuelis have been supporters not just of homeopathy but all sorts of other alternative therapies. I have previously called this strikingly common phenomenon an ‘epiphany‘. And the Samuelis’ latest gift is clearly aimed at promoting alternative medicine in the US. We only need to look at what their other major donation in this area has achieved, and we can guess what is now going to happen at UCI. David Gorski has eloquently written about the UCI donation, and I will therefore not repeat the whole, sad story.

Instead I want to briefly comment on what, in my view, should happen, if a wealthy benefactor donates a large sum of money to medical research. How can one maximise the effects of such a donation? Which areas of research should one consider? I think the concept of prior probability can be put to good use in such a situation. If I were the donor, I would convene a panel of recognised experts and let them advise me where there are the greatest chances of generating important breakthroughs. If one followed this path, alternative medicine would not appear anywhere near the top preferences, I dare to predict.

But often, like in the case of the Samuelis, the donors have concrete ideas about the area of research they want to invest in. So, what could be done with a large sum in the field of alternative medicine? I believe that plenty of good could come it. All one needs to do is to make absolutely sure that a few safeguards are in place:

  • believers in alternative medicine must be kept out of any decisions processes;
  • people with a solid background in science and a track-record in critical thinking must be put in charge;
  • the influence of the donor on the direction of the research must be minimised as much as possible;
  • a research agenda must be defined that is meaningful and productive (this could include research into the risks of alternative therapies, the ethical standards in alternative medicine, the fallacious thinking of promoters of alternative medicine, the educational deficits of alternative practitioners, the wide-spread misinformation of the public about alternative medicine, etc., etc.)

Under all circumstances, one needs to avoid that the many pseudo-scientists who populate the field of alternative or integrative medicine get appointed. This, I fear, will not be an easy task. They will say that one needs experts who know all about the subtleties of acupuncture, homeopathy, energy-healing etc. But such notions are merely smoke-screens aimed at getting the believers into key positions. My advice is to vet all candidates using my concept of the ‘trustworthiness index’.

How can I be so sure? Because I have been there, and I have seen it all. I have researched this area for 25 years and published more about it than any of the untrustworthy believers. During this time I trained about 90 co-workers, and I have witnessed one thing over and over again: someone who starts out as a believer, will hardly ever become a decent scientist and therefore never produce any worthwhile research; but a good scientist will always be able to acquire the necessary knowledge in this or that alternative therapy to conduct rigorous and meaningful research.

So, how should the UCI spend the $ 200 million? Apparently the bulk of the money will be to appoint 15 faculty chairs across medicine, nursing, pharmacy and population health disciplines. They envisage that these posts will go to people with expertise in integrative medicine. This sounds extremely ominous to me. If this project is to be successful, these posts should go to scientists who are sceptical about alternative medicine and their main remit should be to rigorously test hypotheses. Remember: testing a hypothesis means trying everything to show that it is wrong. Only when all attempts to do so have failed can one assume that perhaps the hypothesis was correct.

My experience tells me that experts in integrative medicine are quite simply intellectually and emotionally incapable of making serious attempts showing that their beliefs are wrong. If the UCI does, in fact, appoint people with expertise in integrative medicine, it is, I fear, unavoidable that we will see:

  • research that fails to address relevant questions;
  • research that is of low quality;
  • promotion masquerading as research;
  • more and more misleading findings of the type we regularly discuss on this blog;
  • a further boost of the fallacious concept of integrative medicine;
  • a watering down of evidence-based medicine;
  • irreversible damage to the reputation of the UCI.

In a nutshell, instead of making progress, we will take decisive steps back towards the dark ages.

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.

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.

On this blog, we have often discussed the risks of spinal manipulation. As I see it, the information we have at present suggests that

  • mild to moderate adverse effects are extremely frequent and occur in about half of all patients;
  • serious adverse effects are being reported regularly;
  • the occur usually with chiropractic manipulations of the neck (which are not of proven efficacy for any condition) and often relate to vascular accidents;
  • the consequences can be permanent neurological deficits and even deaths;
  • under-reporting of such cases might be considerable and therefore precise incidence figures are not available;
  • there is no system to accurately monitor the risks;
  • chiropractors are in denial of these problems.

Considering the seriousness of these issues, it is important to do more rigorous research. Therefore, any new paper published on this subject is welcome. A recent article might shed new light on the topic.

The objective of this systematic review was to identify characteristics of 1) patients, 2) practitioners, 3) treatment process and 4) adverse events (AE) occurring after cervical spinal manipulation (CSM) or cervical mobilization. A systematic searches were performed in 6 electronic databases up to December 2014. Of the initial 1043 articles thus located, 144 were included, containing 227 cases. 117 cases described male patients with a mean age of 45 and a mean age of 39 for females. Most patients were treated by chiropractors (66%). Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57%  of the cases and 45.8% had immediate onset symptoms. The overall distribution of gender for CAD was 55% for female. Patient characteristics were described poorly. No clear patient profile, related to the risk of AE after CSM, could be extracted, except that women seemed more at risk for CAD. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AE using standardized terminology.

This article provides little new information; but it does confirm what I have been saying since many years: NECK MANIPULATIONS ARE ASSOCIATED WITH SERIOUS RISKS AND SHOULD THEREFORE BE AVOIDED.

This post is based on an article by Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University, Australia. I took the liberty of slightly modifying his text for the purpose of this blog. The article informs us about the regulation of nonsense which, as I have often argued, is likely to result in nonsense.

Australia’s drugs regulator seems to be endorsing unfounded claims about homeopathy and traditional Chinese medicine as part of its review of how complementary medicines are regulated. In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers can claim their products do, known as “permitted indications”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.

If approved, suppliers will be able to use the permitted indication to market their products. The resulting problem is obvious.  For instance, despite the TGA’s Complaints Resolution Panel upholding complaints of a lack of evidence that magnesium and homeopathy “relieve muscle cramps (and restless legs)”, this permitted indication is on its draft list. Other examples of dodgy claims include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”. The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”. None of them have any basis in fact or science. There are also around 900 additional indications for unspecified “traditions”.

Traditional medicines are not necessarily safe, as emerging data highlights how common adverse reactions and drug interactions really are. For example, Hyland’s homeopathic baby teething products were recalled by the US Food and Drug Administration and then the TGA because they contained high levels of belladonna alkaloids which caused adverse events in hundreds of babies. In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, traditional Chinese medicine represented around 17.3% (equivalent to around 230,000 cases).

Listed medicines are supposed to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed. To safeguard shoppers, consumer representatives, suggested the proposed list of permitted indications should be short and only contain wordings such as, “may assist” or “may help”. For consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the US Federal Trade Commission uses for homeopathic products. For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.

MY CONCLUSION

As I see it, the problem is that the evidence for many of the claims which are about to be allowed is either absent, seriously flawed or negative. Yet, the purpose of any regulation of this kind must be to protect consumers from purchasing ineffective and sometimes dangerous products. Regulators are keen to balance this aim against another aim: helping an industry to thrive. It is never easy to get such a balance right. But to allow nonsense, pseudoscience and overt falsehoods to creep in, must surely be wrong, unethical and illegal.

 

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.

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.

 

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?

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.

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