Edzard Ernst

MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Several investigations have suggested that chiropractic care can be cost-effective. A recent review of 25 studies, for instance, concluded that cost comparison studies suggest that health care costs were generally lower among patients whose spine pain was managed with chiropractic care. However, its authors cautioned that the studies reviewed had many methodological limitations. Better research is needed to determine if these differences in health care costs were attributable to the type of HCP managing their care.

Better research might come from the US ‘Centers for Medicaid and Medicare Services’ (CMS); they conduced a two-year demonstration of expanded Medicare coverage for chiropractic services in the treatment of beneficiaries with neuromusculoskeletal (NMS) conditions affecting the back, limbs, neck, or head.

The demonstration was conducted in 2005–2007 in selected counties of Illinois, Iowa, and Virginia and the entire states of Maine and New Mexico. Medicare claims were compiled for the preceding year and two demonstration years for the demonstration areas and matched comparison areas. The impact of the demonstration was analyzed through multivariate regression analysis with a difference-in-difference framework.

Expanded coverage increased Medicare expenditures by $50 million or 28.5% in users of chiropractic services and by $114 million or 10.4% in all patients treated for NMS conditions in demonstration areas during the two-year period. Results varied widely among demonstration areas ranging from increased costs per user of $485 in Northern Illinois and Chicago counties to decreases in costs per user of $59 in New Mexico and $178 in Scott County, Iowa.

The authors concluded that the demonstration did not assess possible decreases in costs to other insurers, out-of-pocket payments by patients, the need for and costs of pain medications, or longer term clinical benefits such as avoidance of orthopedic surgical procedures beyond the two-year period of the demonstration. It is possible that other payers or beneficiaries saved money during the demonstration while costs to Medicare were increased.

In view of such results, I believe chiropractors should stop claiming that chiropractic care is cost-effective.

Yes, I admit it: over the years, I had formed a vague impression that homeopaths lack humour. Certainly, many comments on this blog seemed to confirm the notion. But now I changed my mind: some homeopaths are intensely funny.

Yesterday, I found a tweet which read: “NCH and homeopathy to be highlighted at the 2016 American Public Health Association’s conference in Denver”. The tweet provided a link which took me to an abstract authored by Alison Teitelbaum from the US National Center for Homeopathy (on their website, this organization tell us that they “inform legislators and work to secure homeopathy’s place in the U.S health care system while working to ensure that homeopathy is accurately represented in the media”).

The abstract in question summarized a presentation for the up-coming APHA-meeting in Denver. It is so hilariously comical that I simply have to share it with you (for those readers are homeopaths, I have added [in square brackets] a few footnotes explaining the humorous side of it):

Background: Over the last 25 years there has been a marked increase in consumer demand for information about complimentary [1] and alternative medicine, including homeopathy. Anecdotal data [2] suggest that homeopathic consumers are very satisfied with homeopathic medicines, and use them to treat acute, self-limiting conditions, however very little data exists in the published literature examining either topic [3]. Therefore, the purpose of this project was to evaluate homeopathic consumers’ use and satisfaction with homeopathic medicines.

Methods: Survey of nearly 20,000 consumers [4] who had purchased at least 1 over-the-counter (OTC) homeopathic medicine in the past 2 years.

Results: [5] More than 95% of respondents indicated they were very or extremely satisfied with the most recent OTC homeopathic medicine they had purchased and used [6]. More than 96% of respondents indicated they were very or extremely satisfied with the results of OTC homeopathic medicines that they had used in general [7]. Over 98% of respondents reported that they were very likely to purchase OTC homeopathic medicines again in the future [8]. More than 97% of respondents indicated that they were very likely to recommend homeopathic medicines to others [9]. Finally, more than 80% of respondents indicated using OTC homeopathic medicines for acute, self-limiting conditions, such as aches and pains; cold and flu symptoms; and digestive upset [10].

Conclusion: These results support anecdotal evidence [11] that homeopathic consumers are satisfied with OTC homeopathic medicines [12], and are using them to treat acute, self-limiting conditions [13]. Additional research is needed to further explore the use of OTC homeopathic medicine in the US for trends, access, and overall awareness about homeopathy [14].

[1] complimentary medicine = healthcare that costs nothing; complementary medicine = healthcare that complements real medicine; homeopathy should belong to the former category because it contains nothing.

[2] please note how ‘anecdotal data’ becomes ‘anecdotal evidence’ by the time we reach the conclusion; little does the author know that THE PLURAL OF ANECDOTE IS NOT ‘DATA’ BUT ‘ANECDOTES’!!!

[3] this statement implies that the author cannot cope with a Medline search, because there are plenty of articles on this subject.

[4] ‘nearly 20 000’ perfectly reflects the scientific rigor of this project (is it really too demanding to provide the exact figure?)

[5] how come we do not learn anything about the response rate of this survey (did ‘nearly’ everyone reply? or did ‘nearly’ everyone not reply?)?

[6] considering that only homeopathy-fans were included, this figure should be 100%!

[7] considering that only homeopathy-fans were included, this figure should be 100%!

[8] considering that only homeopathy-fans were included, this figure should be 100%!

[9] considering that only homeopathy-fans were included, this figure should be 100%!

[10] ‘more than 80%’ of an unknown rate of responders is about as much as a tin of peas. But I am nevertheless relieved that the majority used placebos merely for self-limiting conditions; the 20% who might have used it for life-threatening conditions are probably all dead – sad!

[11] see footnote number 2

[12] this is like doing a survey in a hamburger joint concluding that all consumers love to eat hamburgers.

[13] except, of course, the unknown percentage of non-responders who might all be dead.

[14] I would re-phrase this last sentence as follows: MORE SUCH PRESENTATIONS ARE NEEDED TO PROVIDE COMIC RELIEF TO OTHERWISE DRY AND BORING MEETINGS ON PUBLIC HEALTH.

A thorough report by the Australian group ‘friends of science in medicine’ has just been published. It casts considerable doubt about the therapeutic value of acupuncture. As I think it is a report well worth reading, I reproduce (with the permission of the authors) a large section below:

What could be the mechanisms by which acupuncture might work?

The proponents of acupuncture have postulated possible mechanisms involving neurovascular bundles, trigger points, connective tissue fascial planes, electrical impedance, migration of nuclear tracers, and other factors. These studies are flawed, inconclusive, contradict one another, and have not been replicated. However, interest in acupuncture, particularly for analgesia, has been related to the ‘gate control’ theory (R. Melzack and P.D. Wall, “Pain mechanisms: a new theory”). According to this theory, the activation of large sensory fibres (touch pressure and vibration) inhibits transmission of nociceptive  (pain recognising) pathways carried by small unmyelinated nerve fibres. This was postulated to occur in the spinal cord and might explain the effect of ‘rubbing’ the skin to reduce acute pain, the use of ‘counter irritants’, defined by the USA FDA as “externally applied substances that cause irritation or mild inflammation of the skin for the purpose of relieving pain in muscles, joints and viscera distal to the site of application”. It has been suggested that acupuncture could act as a counter irritant. Interest grew, in the 1970s, with the discovery of brain endogenous opioid peptides, which mimic the actions of morphine on pain. These discoveries triggered extensive research, both in China and around the world, on the involvement of endogenous opioid peptides and a plethora of many neuropeptides and purines in acupunctureinduced analgesia (H.M. Langevin et al., “Mechanical signaling through connective tissue: A mechanism for the therapeutic effect of acupuncture,” N. Goldman et al., “Adenosine A1 receptors mediate local anti-nociceptive effects of acupuncture,” Z.Q. Zhao “Neural mechanism underlying acupuncture analgesia”.) The discovery of novel neurotransmitters capable of affecting nociception gave extra impetus to explain some analgesic responses to sensory stimulation (e.g. mini-review on “Acupuncture and endorphins” in Neuroscience Letters). However while the concept that sensory stimulation affects pain sensation is well established, efforts to date have not established that this phenomenon is responsible for acupuncture induced analgesia. Although acupuncture is supposed to be a very specific intervention involving skin penetration with needles and manipulation (twirling), many studies include a plethora of other interventions, assumed to be, to a lesser or greater degree, equivalent. These include acupressure, electro-acupuncture, transcutaneous nerve electrical stimulation (TENS), laser acupuncture, tiny gold beads implanted under the skin, and injection of homeopathic remedies into acupoints. Electro-acupuncture, manipulated by passing electric currents through implanted needles, is widely used and allows a more objective control over stimulating parameters. Electro-acupuncture appears to be able to activate or deactivate a variety of brain regions and promote the release of endogenous opioid peptides, which are responsible for mediating its analgesic effects. Other non-penetrating methods include stimulation with sound, pressure, heat (moxibustion, sometimes with deliberate burn injury), electromagnetic frequencies (laser stimulation, capsicum plaster, an acu-stimulation device such as Electro-acupuncture of Voll [EAV]), chemical (capsicum plaster and Sweet Bee Venom Pharmaco-puncture), vacuum (cupping), color, waving hands over acupoints, and striking the appropriate meridian on an acupuncture doll with a metal hammer (Tong Ren). Even some forms of bloodletting are thought to involve activation of acupuncture points. Because of the aforementioned scientific studies on the neuroscience of nociception, acupuncture seemed to gain somewhat more plausibility than other forms of alternative medicine. Acupuncture has even been said to have positive effects on animals’ cognitive functions.

Acupuncture and the proven principles of Brain Science

Any hypothesis on the mechanism of action of acupuncture and equivalent interventions needs to be placed within the well established, proven principles of the brain sciences. Brain activity is due to the activity of billions of nerve cells, each generating small electrical currents which carry signals from one end to the other of each nerve cell; and, due to communication through the release of small amounts of chemicals, called neurotransmitters, with other nerve cells and with muscle and glands. These electrical and chemical aspects of the nervous system represent the most important foundations of modern brain science.  This principle of organisation and function of the nervous system became well-established by the middle of the 20th Century, thanks to the research of the Australian neuroscientist, Sir John Eccles, Nobel prize-winner in Medicine because of this discovery. Since then, a plethora of neurotransmitter substances have been identified in the brain and in peripheral organs. Amongst these are endogenous opioids, as mentioned above, and other neuropeptides; these are recognised as important potential modulators of brain function.  Not surprisingly, the idea that activating sensory inputs might affect central neural circuits and that, in particular, acupuncture might well work for analgesia, has triggered extensive research.  While there is evidence for the release by various sensory stimuli, including manual acupuncture, of some endogenous opioids and other endogenous chemical mediators potentially capable of modifying pain stimuli, there is little evidence that this is a specific effect related to any anatomical organisation which could correspond to the ‘meridians’ of TCM. In most cases, any physical or chemical sensory stimulus is likely to result in the release of some endogenous anti-nociceptive substances. The highest quality studies have shown that it doesn’t matter where you insert the needles (acupoints or non-acupoints), and that it doesn’t matter whether the skin is penetrated (in one study, touching the skin with a toothpick worked just as well). The one thing that does seem to matter is whether the patient believes in acupuncture.

It is becoming increasingly clear that the brain processes underlying the physiological ‘placebo effect’ in reducing pain perception share similar neurochemical mechanisms with the sensory stimulation caused by acupuncture and other sensory stimulations. Thus the placebo effect is likely to explain many of the subjective improvements of many interventions, including acupuncture. This similarity explains, in part, why it has been so difficult, in practice, to perform satisfactory clinical trials to test the effectiveness of acupuncture separate from the placebo effect.   Another myth is that acupuncture must be effective because it works on animals, and they wouldn’t respond to a placebo. But animals can’t talk to tell us to how they feel; their owners must interpret their responses by observing the animal’s behaviour, and the owners are susceptible to suggestion. They might inadvertently influence the animal’s behavior by giving it more attention or treating it differently in some way. They might be convinced that they see a change in the animal’s behavior and think that it means the animal feels better.

Using acupuncture for its placebo effect 

Recently, the weight of evidence has convinced some acupuncturists that acupuncture works no better than placebo, but they still advocate using it for its placebo effect. Medical ethicists universally condemn using placebos intentionally since it amounts to lying and can destroy trust in the doctor/patient relationship. In reality, placebos don’t do much; their effects tend to be small in magnitude and short in duration. Patients who use them might defer or reject necessary effective treatment. Placebos can waste time and money, and harm can result when patients are deluded into thinking they are getting better when they really are not. One study found that patients with asthma had the same positive subjective responses to placebos as to an asthma inhaler; but objectively, only the patients in the asthma inhaler group had improvements in lung function. The response to placebos was no better than that of patients in a no-treatment control group. This could have serious consequences, since difficulty in perceiving the severity of an asthma attack is a risk factor for asthma-related death.

Is there clinical evidence for effectiveness of acupuncture in clinical medicine?

The proponents of acupuncture, whether as part of holistic TCM or as a separate technique, advertise that acupuncture can cure a wide range of diseases. Acupuncture has been claimed to be effective for addiction (such as alcoholism), allergies, asthma, bronchitis, carpal tunnel syndrome, chemotherapy-induced nausea and vomiting, constipation, depression, diarrhoea, endometriosis, facial tics, fibromyalgia, gastro-esophageal reflux, headaches, high blood pressure, infertility, irregular menstrual cycles, kidney infections, memory problems, multiple sclerosis, pre-menstrual syndrome, polycystic ovarian syndrome, low back pain, menopausal symptoms, menstrual cramps, osteoarthritis, pain of various natures, pharyngitis, post-operative nausea and vomiting, psychological disorders such as anxiety, sciatica, sensory disturbances, sinusitis, spastic colon (often called irritable bowel syndrome), stroke rehabilitation, tendonitis, tennis elbow, tinnitus, urinary problems such as incontinence, sports injuries, sprains, strains, ulcers, and whiplash.

Acupuncture trials and pitfalls 

Clinical research on acupuncture is inherently difficult. The practice of acupuncture is not standardised, and some studies of ‘acupuncture’ are actually of electro-acupuncture, ear acupuncture, or other variants. It’s next to impossible to do double-blind studies, so confounding factors cannot be eliminated. The best studies use a retractable needle in a sheath, so that the patient can’t tell whether the skin has been penetrated or only touched by the needle. The results are highly variable: it’s easy to find studies to support a belief in acupuncture, but it’s even easier to find studies showing that it doesn’t work.  The rationale for acupuncture’s acceptance in some aspects of clinical medicine, particularly in emergency medicine and pain clinics, has begun to crumble on closer examination of the evidence, mostly because of the excessively variable nature of the interventions involved in various studies which did not clarify the nature of the sham interventions used and any placebo effects.   Recent reviews of the effectiveness of  acupuncture on pain in general are rather damning. There have, over several decades, been several thousand acupuncture studies. After all this clinical research, acupuncture has not been clearly demonstrated to be effective for any indication. In short it is more than reasonable to suggest that acupuncture doesn’t work being no more than “a theatrical placebo”.  Traditional Chinese acupuncture is no better for treating menopausal symptoms than a ‘sham’ version using blunt needles, according to a University of Melbourne study, published in the Annals of Internal Medicine, involving 327 Australian women over 40 who had at least seven moderately hot flushes daily. Half were given ten sessions of standard Chinese medicine acupuncture, where thin needles were inserted into the body at specific points. The others had their skin stimulated with blunt-tipped needles, which had a milder effect without penetrating the skin. After eight weeks of treatment, both had led to a 40% improvement in the severity and frequency of hot flushes; this was sustained six months later. However, there was no statistical difference between the two therapies. The authors said that both groups might have improved as a result of the placebo effect or because attending a clinic to talk about symptoms helped. The authors also noted that hot flushes tended to improve spontaneously with time adding “This was a large and rigorous study, and we are confident there is no additional benefit from inserting needles compared with stimulation from pressuring the blunt needles without skin penetration for hot flushes.”  The most positive results from acupuncture have been for pain and post-operative nausea and vomiting (PONV). But even for those, the evidence is unconvincing. For PONV, the most recent meta-analysis indicated a small effect of P6 acupoint stimulation, but it mixed studies of acupuncture with electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure. There were questionable randomisation procedures, incomplete data, and the conclusion of the reviewers (that P6 acupoint stimulation “prevented PONV”) was not justified by the data. There is a lot of ‘noise’ in the data from these studies, but there doesn’t appear to be any ‘signal‘ mixed with the ‘noise’.  It has been shown that the analgesic benefits of acupuncture are partially mediated through placebo effects related to the acupuncturist’s behavior. It is becoming increasingly clear that any reported benefits of acupuncture are largely due to the surrounding ritual, the beliefs of patient and practitioner, and the other nonspecific effects of treatment, not to the needles themselves. The team studying PONV also examined ‘Acupuncture for pelvic and back pain in pregnancy: a systematic review’. They concluded “limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy”.  A systematic review of acupuncture for various pain conditions found a mix of negative, positive and inconclusive results. Out of 57 systematic reviews, there were only 4 pain conditions for which more than one systematic review reached the same conclusion: in 3 cases, they agreed that it was ineffective, and in only one (neck pain) was it agreed that it was effective.  That finding is suspect, because it doesn’t make sense that a treatment could relieve pain only in one part of the body but not elsewhere.  Over the past 10-15 years the Cochrane collaboration has addressed the efficacy of acupuncture for many of these indications. When clinical trials have been performed properly, lack or insufficient evidence of effectiveness for acupuncture was demonstrated in most cases. The following is a list, not exhaustive, of such trials.  In thirty trials for depression, with 2,812 participants, manual and electro acupuncture were compared with medication; they found no difference between the two groups.  A review by the Cochrane Collaboration on the question ‘Do acupuncture and related therapies help smokers who are trying to quit’ “did not find consistent evidence that active acupuncture or related techniques increased the number of people who could successfully quit smoking”.  A study by RMIT researchers in 2016 showed that acupuncture is no better than placebo for menopausal symptoms such as hot flashes.  A Cochrane Collaboration study (2014) demonstrated no effects on functional dyspepsia. A similar lack of effect on rheumatoid arthritis was demonstrated in 2005.  Even proponents of acupuncture from the team at the RMIT in Melbourne, in their attempt to prove that acupuncture is effective in a “range of health conditions”, admitted, “No solid conclusion of which design is the most appropriate sham control of Ear-acupuncture/ear-acupressure could be drawn in this review”.  Very clear experimental work performed by a University of Melbourne team on one of the projects funded by the NH&MRC on laser acupuncture, “Acupuncture for Chronic Knee Pain published A Randomized Clinical Trial on chronic knee pain”, showed that neither needle nor laser acupuncture significantly improved pain and concluded that their findings did not support acupuncture for these patients.   A paper in Obstetrics & Gynecology in 2008 “Acupuncture to Induce Labor: A Randomized Controlled Trial” concluded “Two sessions of manual acupuncture, using local and distal acupuncture points, administered 2 days before a scheduled induction of labor did not reduce the need for induction methods or the duration of labor for women with a post-term pregnancy”.

Trials not performed sufficiently well and therefore “need to be repeated” 

Despite the several decades of significant funding for, and research on, acupuncture and, in general, on alternative medicines in Australia and around the world, far too often the conclusion from clinical trials is “more research is needed”. The excuses given in the numerous reviews, mostly by the proponents, are  insufficient numbers of patients or trials or insufficient control subjects. The reality is more likely due to the reality that there is an absence of effectiveness. For example, a review on “Acupuncture to treat common reproductive health complaints: An overview of the evidence” concluded “Acupuncture to treat premenstrual syndrome or polycystic ovarian syndrome and other menstrual related symptoms is under-studied, and the evidence for acupuncture to treat these conditions is frequently based on single studies. Conclusion: Further research is needed”. In a review, “Pain Research in Complementary and Alternative Medicine in Australia: A Critical Review”, the authors concluded that, because of the poor design and execution of research papers on pain and alternative medicines, “The quantity and the quality of CAM pain research in Australia is inconsistent with the high utilization of the relevant CAM therapies by Australians. A substantial increase in government funding is required. Collaborative research examining the multimodality or multidisciplinary approach is needed”. It has been claimed that surgery can be performed using only acupuncture anesthesia. A widely publicised picture of a patient allegedly undergoing open-heart surgery under acupuncture anesthesia appears to be a fake: it shows her with an open chest cavity that would make her lungs collapse, she is not on a respirator and a heartbypass machine does not appear to be in use. Also, the incision is in the wrong place for the procedure being described, and the photo is curious in other respects (such as the position of the patient’s head). A recent BBC video of surgery on a conscious patient anaesthetised with acupuncture was similarly misleading. Researchers at the Centre for Complementary Medicine Research at the University of Western Sydney, commenting on studies of acupuncture for menstrual problems stated, “Five systematic reviews were included, and six RCTs. The symptoms of the menopause and of dysmenorrhea have been subject to greater clinical evaluation through RCTs, and the evidence summarised in systematic reviews, than any other reproductive health complaint. The evidence for acupuncture to treat dysmenorrhea and menopause remains unclear, due to small study populations and the presence of methodological bias.  For example, a review on “Acupuncture to treat common reproductive health complaints: An overview of the evidence” concluded “Acupuncture to treat premenstrual syndrome or polycystic ovarian syndrome and other menstrual related symptoms is under-studied, and the evidence for acupuncture to treat these conditions is frequently based on single studies. Conclusion: Further research is needed”.  Many other studies by the Cochrane Collaboration concluded that there was insufficient evidence for recommending the use of acupuncture for the conditions investigated, as listed as follow: ADHD in children and adolescents (2011); autism spectrum disorders (ASD) (2011); Bell’s palsy (2010); cancer-related pain (2015); glaucoma (2013); depression (2010); dysphagia in acute stroke (2008); tennis elbow (2002); ‘fibromyalgia’ (2013); induction of labour (2013); menopausal hot flushes (2013); mumps (2014); nearsightedness in children (2011); hypoxic ischemic encephalopathy in newborn babies (2013); pain in endometriosis (2011); period pain (2011); chronic asthma (1999); urinary incontinence (2013); stroke rehabilitation (2006); uterine fibroids (2010); labour pains (2011); vascular dementia (2007); nausea and vomiting in early pregnancy (2015); obesity (2015). Even TENS appears to give insufficient evidence for improving dementia (2003).

Reasonable trials with evidence for small effects.

A Cochrane study on acupuncture and dry needling for low back pain, based on 35 randomised clinical trials in 2005, reported a very small effect. Another Cochrane study in 2009 suggested that acupuncture should be considered a treatment option for migraine prophylaxis, despite finding that “there was no evidence of an effect of true acupuncture over sham interventions”.  A Cochrane study in 2006 found moderate evidence for a small improvement in chronic neck pain while a review in 2009 suggested that there was benefit from the use of acupuncture to treat Tension-type headache  Almost all trials of alternative medicines seem to end up with the conclusion “more research is needed”. After more than 3,000 trials, we should recognise that the need for more trials is dubious…

Conclusion

Acupuncture has been studied for decades and the evidence that it can provide clinical benefits continues to be weak and inconsistent. There is no longer any justification for more studies. There is already enough evidence to confidently conclude that acupuncture doesn’t work. It is merely a theatrical placebo based on pre-scientific myths.   All health care providers who accept that they should base their treatments on scientific evidence whenever credible evidence is available, but who still include acupuncture as part of their health interventions, should seriously revise their practice.  There is no place for acupuncture in Medicine.

[the original report is fully referenced]

On this blog, I have discussed the lamentable quality of TCM products before (e. g. here, here and here). In a nutshell, far too high percentages of them are contaminated with toxic substances or adulterated with prescription drugs. It is no question: these deficits put many consumers at risk. Equally, there is no question that the problem has been known for decades.

For the Chinese exporters, such issues are a great embarrassment, not least because TCM-products are amongst the most profitable of all the Chinese exports. In the past, Chinese officials have tried to ignore or suppress the subject as much as possible. I presume they fear that their profits might be endangered by being open about the dubious quality of their TCM-exports.

Recently, however, I came across a website where unusually frank and honest statements of Chinese officials appeared about TCM-products. Here is the quote:

China is to unroll the fourth national survey of traditional Chinese medicine (TCM) resources to ensure a better development of the industry, said a senior health official…

With the public need for TCM therapies growing, the number of medicine resources has decreased and people have turned to the cultivated ones. However, due to a lack of standards, the cultivated TCM resources are sometimes less effective or even unsafe for human use, said Wang Guoqiang, director of the State Administration of TCM, at a TCM seminar held in Kunming, Yunnan Province in southwest China.

There is a pressing need to protect TCM resources, Wang said. “I’ve heard people saying that medicine quality will spell doom for the TCM industry, which I must admit, is no exaggeration,” he said.

The survey has been piloted in 922 counties in 31 provinces in China since 2011. According to its official website, it will draw a clear picture of the variety, distribution, storage and growth trends of TCM resources, including herbs, animals, minerals and synthetic materials.

TCM includes a range of traditional medical practices originating in China. It includes such treatments as herbal medicine, acupuncture, massage (tuina), exercise (qigong) and dietary therapy.

Although well accepted in the mainstream of medical care throughout East Asia, TCM is considered an alternative medical system in much of the western world and has been a source of controversy. A milestone in the recognition of TCM came when Chinese pharmaceutical chemist Tu Youyou won a Nobel Prize in 2015 for her discovery of Artemisinin, a medicinal herb, to help treat malaria.

END OF QUOTE

Surely, these are remarkable, perhaps even unprecedented statements by Chinese officials:

…cultivated TCM resources are sometimes less effective or even unsafe for human use…

…medicine quality will spell doom for the TCM industry…

Let’s hope that, after such words, there will be appropriate actions… finally.

On a good day, I get several emails from complete strangers; some are complimentary, others are critical, and others again are just strange. Few are stranger than the exchange I am about to disclose.

The author asked me twice to treat his/her emails with ‘trust and confidence’; after the second email, I nevertheless felt that I should not respect this wish but needed to share this brief exchange with my readers. I have, however, erased all the details that would allow an identification of the author.

 

INITIAL EMAIL of 18/7/2016

I am responding to you latest post regarding “Informed Consent”. I have decided to do so because my instincts suggest that we may in fact have an empathy in our individual objective to establish an evidence base for complementary medicine. However, I do not have any empathy with many of the contributors to your blog and especially with those that have a desire to “grind homeopathic vets and feed them to the pigs” Given that you moderate the site, I am surprised that you allowed such a post.

As you are aware, I obtained a copy of your book “A Scientist in Wonderland” which I have read with considerable interest and as you know, I have posted extracts on your blog. In this respect I make the following observations:

1. Your early experiences of homeopathy were positive and on this basis I find great difficulty in accepting that you are as anti-homeopathy as you publically state. From my own experience, this is not logical.

2. I am of the opinion that the sad loss of your Hungarian friend and colleague is an influencing factor, particularly as you avoided any mention of him receiving any form of alternative medicine.

3. I can empathise with your frustration at the lack of support from the alternative medicine community, as I have experienced this in my own efforts.

4. I am inclined to accept the possibility that you are using the blog to deliberately provoke the homeopathic community into action from a long standing but understandable state of complacency. (If you know that something works, then why is there a need to prove it).

5. I find difficulty to believe that you are at home surrounded by such closed minded individuals, because, historically, you have always moved on from such situations. However, I am not sure that you know how you can escape from the trap that you now find yourself in. Is this what you want for the rest of your life?

For a variety of reasons, I embarked on this … venture as a means of finding evidence that these therapies do work and have found that the homeopathy community is somewhat less than supportive in my efforts, so I do understand your potential frustration.

I appreciate that my observations are assumption based and may be wishful thinking on my part; however, if my assumptions have validity, please contact me, otherwise ignore this message.

If you do choose to pursue this conversation, then it must take place under the strict condition of TRUST & CONFIDENCE.

 

MY REPLY of 18/7/2016

thank you for your email. you say you read my memoir; may I suggest you read it again – because the answers to your questions seem to be all in there. your assumptions about me are quite wrong, and I think my book explains why.

best regards
e ernst

 

THE RESPONSE of 21/7/2016

In Britain we have a saying “Don’t mention the war when speaking to a German”, so out of respect I refrained from mentioning the Nazi regime in my last message; however, as you have made an implied reference to it, I will now comment.

I have some six years of close working experience with a large German organisation … so that I am fully aware of the significant differences between the German and British mentality and approach to life. I am therefore able to appreciate many of the difficulties that you will have encountered when arriving in this country to take up the Exeter post, which by definition was designed to advise the UK alternative therapy community how to do things properly!

The Anglo/Germanic axis is a significant challenge under normal circumstances but for you to arrive in this country and make direct comparisons between alternative medicine and the Third Reich in a country that spearheaded the fight against the Nazi’s at a cost of nearly half a million British lives was a fatal mistake on your part.

Having spent some forty years in and around the alternative health world here in Britain, India and the USA I don’t think your view point can be further from the truth. What amazes me is that you do not moderate Nazi type comments such as “grinding homeopaths and feeding them to pigs” from your blog which is a complete contradiction to your reasoning.

Your blog purports to provide cautionary advice to would be patients choosing alternative health options but your band of followers seem to have no understanding whatsoever as to the importance of respect for others. They seem to believe that from the offset, respect has to be earned, which implies judgement. Any doctor or therapist that starts from this view point when dealing with a patient, should not be treating patients at all. Empathy and respect are key factors in the healing process and those that automatically practice this naturally operate under and accept a moral code of ethics which forms part of all training within the main alternative treatments. The fundamental ethic behind all medicine is “first do no harm”. How can this be achieved if you do not respect the patient, regardless of his views?

At a personal level, I am concerned that your early experiences have distorted your views and unfortunately you have managed to alienate yourself from the very form of healthcare that would best resolve these issues without the need for suppressive drugs.

I suggest that you re-read your book and honestly ask yourself if the “peaceful vantage point” referred to on page 170, in any way measures up to the “peaceful, happy time” you mention on page 36.

I again extend my offer of an exploratory conversation in an atmosphere of “trust and confidence”.

END OF QUOTE

I do not feel like adding any comments just now… perhaps just a few questions:

How is it possible that someone who has obviously read quite a bit of what I have published misunderstands so much of it? Deluded? Demented? Or worse?

What a silly question! At least this is what most sceptics would say: if we are not sure that it works, we do not need to spend any thoughts on a potential mechanism!

However, in the realm of acupuncture, the potential mode of action remains a hotly debated and fundamentally relevant issue.

The TCM folks, of course, ‘knew’ all along how acupuncture works: it re-balances the life-forces yin and yang. This is a nice theory – it has but one disadvantage: it has no bearing whatsoever on reality. Vitalistic ideas such as this one have long been proven to be nothing but fantasy.

Meanwhile, several more plausible hypotheses have been developed, and hundreds of papers have been published on the subject. One recent article, for instance, suggests a range of mechanisms including microinjury, increased local blood flow, facilitated healing, and analgesia. Acupuncture may trigger a somatic autonomic reflex, thereby affecting the gastric and cardiovascular functions. Acupuncture may also change the levels of neurotransmitters such as serotonin and dopamine, thereby affecting the emotional state and craving… By affecting other pain-modulating neurotransmitters such as met-enkephalin and substance P along the nociceptive pathway, acupuncture may relieve headache. Acupuncture may affect the hypothalamus pituitary axis and reduce the release of the luteinizing hormone…

Another article states that the Western explanation for acupuncture effectiveness is based upon more than half a century of basic and clinical research, which identified the activation of sensory system and the subsequent activity-dependent regulation of neurotransmitters, neurohormones, and several classes of neuromodulators as plausible mechanism for the acupuncture‘s therapeutic properties. The regulation of neurotrophins’ expression and activity is one of the possible neurophysiological mechanisms underlying acupuncture‘s effects on neuropathic pain, nerve injury, neurodegeneration, and even in the regulation of gonadal functions…

Recently Burnstock proposed that mechanical deformation of the skin by needles and application of heat or electrical current leads to release of large amounts of ATP from keratinocytes, fibroblasts and other cells in skin; the ATP then occupies specific receptor subtypes expressed on sensory nerve endings in the skin and tongue; the sensory nerves send impulses through ganglia to the spinal cord, the brain stem, hypothalamus and higher centres; the brain stem and hypothalamus contain neurons that control autonomic functions, including cardiovascular, gastrointestinal, respiratory, urinogenital and musculo-skeletal activity. Impulses generated in sensory fibres in the skin connect with interneurons to modulate (either inhibition or facilitation) the activities of the motoneurons in the brain stem and hypothalamus to change autonomic functions; specifically activated sensory nerves, via interneurons, also inhibit the neural pathways to the pain centres in the cortex.

A brand-new article in the journal SCIENTIFIC AMERICAN puts the hypothesis in perspective:

…scientists have been studying a roster of potential biological pathways by which needling might relieve pain. The most successful of these efforts has centered on adenosine, a chemical believed to ease pain by reducing inflammation. A 2010 mouse study found that acupuncture needles triggered a release of adenosine from the surrounding cells into the extracellular fluid that diminished the amount of pain the rodents experienced. The mice had been injected with a chemical that made them especially sensitive to heat and touch. The researchers reported a 24-fold increase in adenosine concentration in the blood of the animals after acupuncture, which corresponded to a two-thirds reduction in discomfort, as revealed by how quickly they recoiled from heat and touch. Injecting the mice with compounds similar to adenosine had the same effect as acupuncture needling. And injecting compounds that slowed the removal of adenosine from the body boosted the effects of acupuncture by making more adenosine available to the surrounding tissue for longer periods. Two years later a different group of researchers went on to show that an injection of PAP, an enzyme that breaks other compounds in the body down into adenosine, could relieve pain for an extended chunk of time by increasing the amount of adenosine in the surrounding tissue. They dubbed that experimental procedure “PAPupuncture.”

Both sets of findings have excited researchers—and for good reason. The current options for treating pain are limited and rely mostly on manipulating the body’s natural pain-management system, known as the opioid system. Opioid-based painkillers are problematic for several reasons. Not only does their efficacy tend to wane over time, but they have been linked to an epidemic of addiction and overdose deaths across the U.S.—so much so that the Centers for Disease Control and Prevention has recently advised doctors to seriously restrict their use. The available nonopioid pain treatments are few; many of them require multiple injections or catheterization to work; and they often come with side effects, such as impaired movement. Adenosine offers an entirely new mechanism to exploit for potential treatments—one that may come with fewer side effects and less potential for addiction. What is more, adenosine can be made to circulate in the body for prolonged stretches. Pharmaceutical companies are actively investigating adenosine-related compounds as potential drugs.

But however promising adenosine may be as a treatment, the findings from this research do not prove that acupuncture itself “works.” For one thing, the researchers did not show that the release of adenosine was specific to acupuncture. Acupuncture needles might cause adenosine to flood the surrounding tissue, but so might a hard pinch, or applied pressure, or any number of other physical insults. In fact, both of the studies found that when adenosine was turned on in mouse tissue by other mechanisms, the pain response was equal to or better than the response generated by acupuncture. For another thing, the study results offered no support for the use of acupuncture to treat any of the other conditions for which the procedure is often advertised. A localized adenosine response may mitigate localized pain. That does not mean it can also cure insomnia or infertility.

It may well be that the reams of research scientists have done on acupuncture have lit the path toward improved understanding of—and eventually better treatments for—intractable pain. But it may also be time to take whatever bread crumbs have been laid out by that work and move on.

END OF QUOTE

As we see, there is no shortage of potential explanations as to HOW acupuncture works. The most plausible theory still is that it works largely or even exclusively via a placebo effect.

Due to this type of mechanistic research, acupuncture has gained much credibility. The question is, does it deserve it? In my view, it would be much more fruitful to first make sure THAT acupuncture works (beyond a placebo response) and, if so, for what conditions. The question HOW it works is unquestionably interesting but in the final analysis it probably is secondary.

Informed consent is a basic ethical principle and a precondition for any medical or surgical procedure (e. g. a therapeutic intervention or a diagnostic test). Essentially, there are 4 facets of informed consent:

  1. the patient must have decision-making capacity,
  2. the patient’s decision must be free from coercion or manipulation,
  3. all relevant information must be disclosed to the patient,
  4. the patient must not merely be told but must understand what he/she has been told.

It seems to me that points 1, 2 and 4 are more or less the same in alternative as in conventional medicine. Point 3, however, has fundamentally different implications in the two types of healthcare.

What is meant by ‘all relevant information’? There seems to be general agreement that this should include the following elements:

  1. the indication,
  2. the nature of the procedure,
  3. its potential benefits,
  4. its risks,
  5. other options for the proposed procedure, including the option of doing nothing at all.

If we carefully consider these 5 elements of ‘all relevant information’, we soon realise why there might be profound differences between alternative and conventional medicine. These differences relate not so much to the nature of the procedures but to the competence of the clinicians.

At medical school, doctors-to-be learn the necessary facts that should enable them to adequately deal with the 5 elements listed above. (This does not necessarily mean that, in conventional medical or surgical practice, informed consent is always optimal. But there is little doubt that, in theory, it could be optimal.)

By contrast, alternative practitioners have not normally been to medical school and will have gone through an entirely different type of training. Therefore, the question arises whether – even in theory – they are able to transmit to their patients all essential information as outlined above.

Let’s try to address this question by looking at concrete cases: a patient with frequent headaches consults an alternative practitioner for help. For the sake of argument, the practitioner could be:

  • a chiropractor,
  • an acupuncturist,
  • a homeopath,
  • a naturopath,
  • a traditional herbalist.

Are these alternative practitioners able to convey all the relevant information to their patient before starting their respective treatments?

THE CHIROPRACTOR

  1. Can he provide full information on the indication? In all likelihood he would treat the headache as though it was caused by a spinal subluxation. If our patient were suffering from a brain tumour, for instance, this might dangerously delay the diagnosis.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Many chiropractors deny any risk of spinal manipulation.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? Probably yes for cervicogenic headache. No for most other differential diagnoses.

THE TRADITIONAL ACUPUNCTURIST

  1. Can he provide full information on the indication? The patient might be treated for an assumed ‘energy blockage’; other diagnoses might not be given adequate consideration.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Perhaps.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No

THE CLASSICAL HOMEOPATH

  1. Can he provide full information on the indication? No, for a classical homeopath, the totality of the symptoms is the only valid diagnosis.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? Doubtful.
  4. Can he explain its risks? Doubtful.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

THE NATUROPATH

  1. Can he provide full information on the indication? Doubtful.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Doubtful.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

THE TRADITIONAL HERBALIST

  1. Can he provide full information on the indication? No.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? He is likely to have a too optimistic view on this.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

The answers provided above are based on my experience of more than 20 years with alternative practitioners; I am aware of the degree of simplification required to give short, succinct replies. The answers are, of course, assumptions as well as generalisations. There may well be individual practitioners who would do better (or worse) than the fictitious average I had in mind when answering the questions. Moreover, one would expect important national differences.

If my experience-based assumptions are not totally incorrect, their implications could be most significant. In essence they suggest that, in alternative medicine, fully informed consent can rarely, if ever, be provided. In turn, this means that the current practice of alternative medicine cannot be in line with the most fundamental requirements of medical ethics.

There is very little research on any of these  issues, and thus hardly any reliable evidence. Therefore, this post is simply meant as a deliberately provocative essay to stimulate debate – debate which, in my view, is urgently required.

 

Medical ethics are central to any type of healthcare – and this includes, of course, alternative medicine. The American Medical Association (AMA) have just published their newly revised code of ethics, AMA Principles of Medical Ethics.

It has long been my impression that, in alternative medicine, ethics receive no or far too little attention. Some alternative practitioners thrive to be able to call themselves ‘physicians’. Therefore, it seems interesting to ask whether they would also be able to comply with the ethical duties of a physician as outlined by the AMA.

The following 9 points are taken without change from the new AMA code; in brackets I have put my own, very brief comments pertaining to alternative practitioners. There is much more to be said about each of these points, of course, and I encourage my readers to do so in the comments section.

  1. A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights. [Most alternative practitioners use unproven treatments; I doubt whether this can be called ‘competent medical care’.]
  2. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities. [Treating patients with unproven therapies in the absence of fully informed consent is arguably unprofessional, dishonest and deceptive. Crucially, alternative practitioners never object to even the worst excesses of quackery that occur in their realm.]
  3. A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient. [Treatment with unproven therapies can hardly be in the best interest of the patient.]
  4. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law. [The right of patients includes full informed consent which is, according to my impression, rare in alternative medicine.]
  5. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated. [Alternative medicine is frequently out of line with or even opposed to medical knowledge.]
  6. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.
  7. A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health. [Some activities of some alternative practitioners are directly opposed to public health, for instance when they advise against immunising children.]
  8. A physician shall, while caring for a patient, regard responsibility to the patient as paramount. [Arguably this is not possible when using unproven therapies.]
  9. A physician shall support access to medical care for all people. [Some alternative practitioners advise their patients against accessing conventional healthcare.]

As I stated above, medical ethics are neglected in alternative medicine. The 9 points of the AMA together with my comments go some way towards explaining why this is so. If ethical principles were applied to alternative medicine, much of it would have to stop instantly.

The UK petition to ban homeopathy for animals has so far achieved well over 3 000 signatures. Remarkably, it also prompted a reaction from the Faculty of Homeopathy which I reproduce here in full:

Response to petition calling on the RCVS to ban homeopathy

Homeopathy has a long history of being used successfully in veterinary practice for both domestic and farm animals. The EU recommends its use in its regulations on organic farms and is funding research into veterinary homeopathy as a way of reducing antibiotic use in livestock. It is nonsense to suggest that responsible pet owners and farmers are unable to distinguish between effective and ineffective medicines; they continue to use homeopathy because they see its benefits.

Membership of the Faculty of  Homeopathy (VetMFHom) is bestowed on qualified veterinary surgeons who have completed a minimum of three years study of homeopathy and after a rigorous examination procedure. It differentiates the qualified veterinary homeopath from an unlicensed healer.

In a statement, the Royal College of Veterinary Surgeons said “… homeopathy is currently accepted by society and recognised by UK medicines legislation, and does not, in itself, cause harm to animals”. Before going on to say it could see no justification for banning veterinary surgeons from practising homeopathy.

In an age when antibiotic resistance is such an important issue, veterinary surgeons and farmers who have found they can limit the use of these drugs by using homeopathy should be applauded and not attacked.


Peter Gregory
BVSc MRCVS VetFFHom
Veterinary Dean, Faculty of Homeopathy

 

Such sentiments resonate with those of the UK’s most influential supporter of homeopathy, Prince Charles. Speaking at a global leaders summit on antimicrobial resistance, Prince Charles  recently warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. “As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries at The Royal Society in London. “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”

It seems that both Prince Charles and Peter Gregory believe that homeopathy can be employed to reduce the use of antibiotics in animals. So, let’s analyse this hypothesis a little closer.

The way I see it, the belief must be based on one of two assumptions:

  1. Homeopathic remedies are effective in treating or preventing bacterial infections.
  2. If farmers administer homeopathic remedies to their life-stock, they are less likely to administer unnecessary antibiotics.

Assumption No 1 can be rejected without much further debate; there is no evidence whatsoever that homeopathic remedies have antibiotic efficacy. In fact, the consensus today is that highly diluted homeopathic remedies are pure placebos.

Assumption No 2, however, might be more plausible and therefore deserves further scrutiny.  If we do not tell the farmers nor the vets that homeopathic remedies are placebos, if, in other words, we mislead them to think they are efficacious medicines, they might give them to their animals instead of antibiotics. Consequently, the usage of antibiotics in animals would decrease. This strategy sounds plausible but, on second thought, it has many serious drawbacks:

  1. The truth has a high value in itself which we would disregard at our peril.
  2. One might not be able to keep the truth from the farmers and even less able to hide it from vets.
  3. If we mislead farmers and vets, we must also mislead the rest of the population; this means lots of people might start using homeopathic placebos even for serious conditions.
  4. Misleading farmers, vets and the rest of the population is clearly unethical.
  5. Misleading farmers and vets in this way might not be necessary; if there is abuse of antibiotics in farming, we ought to tackle this phenomenon directly.
  6. Misleading farmers and vets might be dangerous for at least two reasons: firstly, animals who truly need antibiotics would not receive adequate treatment; secondly, farmers and vets might eventually become convinced that homeopathy is efficacious and would therefore use it in all sorts of situations, even for serious diseases of humans.

Whichever way I twist and turn the assumption No 2, I fail to arrive at anything remotely sensible. But this leaves me with a huge problem: I would have to conclude that both the Veterinary Dean, Faculty of Homeopathy and the heir to the throne are bonkers… and, surely, this cannot be right either!!!

 

Yesterday, a press-release reached me announcing that a Chinese herbal medicine, ‘Phynova Joint and Muscle Relief Tablets’, containing the active ingredient Sigesbeckia, is now on sale in the UK for the first time in Boots The Chemist: 

Sigesbeckia is the first traditional Chinese treatment granted a traditional herbal registration (THR) under the traditional herbal medicines product directive in the UK, by drug safety watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA).  Oxford based Phynova which manufactures the product was granted the UK licence last year. 

Containing 500mg of the active ingredient, Phynova Joint and Muscle Relief Tablets are specially formulated for the relief of backache, arthritis, minor sports injuries, rheumatic or muscular pains and general aches and pains in muscles or joints.  Two tablets are taken each day, one in the morning and one in the evening. They have no known side effects and are non-addictive. .. 

The product, which retails at £19.99 for one month’s supply of 60 tablets, is available in 950 UK Boots outlets and online via Click and Collect from all stores.  It will be sold both Over the Counter (OTC) by pharmacist staff and off the shelf as part of Boots’ pain relief fixture… 

END OF QUOTE

What on earth is a ‘joint and muscle relief’? Personally I do not want to be relieved of my joints and muscles!!!

Yes, I know, they probably mean ‘joint and muscle pain relief’ but were not allowed to say so because this is a medical indication.

And what about the claim of ‘no side-effects’; is it possible that a pharmacological treatment has positive effects without any risks at all? This is not what they told me during my pharmacology course, if I remember correctly. And anyway, even placebos have side-effects!

I admit, I was puzzled.

The covering letter of the press-release provided more amazement: it informed me that “Phynova joint and muscle relief contains the active ingredient Sigesbeckia which has been through clinical trials and has been used for pain relief in China for hundreds of years…” It was the remark about clinical trials (PLURAL!!!) that caught my interest most.

So, I looked up ‘Sigesbeckia’ on Medline and found as good as nothing. This is mainly because the plant is spelled correctly ‘Siegesbeckia’ in honour of the famous botanist Siegesbeck.

Looking up ‘Siegesbeckia’, I found many pre-clinical studies but no clinical trials.

Next I searched for a comment from the MHRA and discovered that their account makes it very clear that a licence has been granted to this product “exclusively upon long standing use… and not upon data from clinical trials.”

So, who is right?

Are there clinical trials of this product or not? And, if there are any, where are they?

Perhaps someone from Phynova can enlighten us?

 

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