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

TCM

Motor aphasia is common among patients with stroke. Acupuncture is recommended by TCM enthusiasts as a so-called alternative medicine (SCAM) for poststroke aphasia, but its efficacy remains uncertain.

JAMA just published a study that investigated the effects of acupuncture on language function, neurological function, and quality of life in patients with poststroke motor aphasia.
The study was designed as a multicenter, sham-controlled, randomized clinical trial. It was conducted in 3 tertiary hospitals in China from October 21, 2019, to November 13, 2021. Adult patients with poststroke motor aphasia were enrolled. Data analysis was performed from February to April 2023.

Eligible participants were randomly allocated (1:1) to manual acupuncture (MA) or sham acupuncture (SA) groups. Both groups underwent language training and conventional treatments.
The primary outcomes were the aphasia quotient (AQ) of the Western Aphasia Battery (WAB) and scores on the Chinese Functional Communication Profile (CFCP) at 6 weeks. Secondary outcomes included WAB subitems, Boston Diagnostic Aphasia Examination, National Institutes of Health Stroke Scale, Stroke-Specific Quality of Life Scale, Stroke and Aphasia Quality of Life Scale–39, and Health Scale of Traditional Chinese Medicine scores at 6 weeks and 6 months after onset. All statistical analyses were performed according to the intention-to-treat principle.

Among 252 randomized patients (198 men [78.6%]; mean [SD] age, 60.7 [7.5] years), 231 were included in the modified intention-to-treat analysis (115 in the MA group and 116 in the SA group). Compared with the SA group, the MA group had significant increases in AQ (difference, 7.99 points; 95% CI, 3.42-12.55 points; P = .001) and CFCP (difference, 23.51 points; 95% CI, 11.10-35.93 points; P < .001) scores at week 6 and showed significant improvements in AQ (difference, 10.34; 95% CI, 5.75-14.93; P < .001) and CFCP (difference, 27.43; 95% CI, 14.75-40.10; P < .001) scores at the end of follow-up.

The authors concluded that in this randomized clinical trial, patients with poststroke motor
aphasia who received 6 weeks of MA compared with those who received SA demonstrated
statistically significant improvements in language function, quality of life, and neurological
impairment from week 6 of treatment to the end of follow-up at 6 months after onset.

I was asked by the SCIENCE MEDIC CENTRE to provide a short comment. This is what I stated:

Superficially, this looks like a rigorous trial. We should remember, however, that several groups, including mine, have shown that very nearly all Chinese acupuncture studies report positive results. This suggests that the reliability of these trials is less than encouraging. Moreover, the authors state that real acupuncture induced ‘de chi’, while sham acupuncture did not. This shows that the patients were not blinded and the outcomes might easily be due to a placebo response.

Here, I’d like to add two further points:

Dragons’ Den is a British reality television business programme, presented by Evan Davis and based upon the original Japanese series. The show allows several entrepreneurs an opportunity to present their varying business ideas to a panel of five wealthy investors, the “Dragons” of the show’s title, and pitch for financial investment while offering a stake of the company in return.

It has been reported that Giselle Boxer began selling needle-free acupuncture kits for ears after being diagnosed with myalgic encephalomyelitis (ME). She said the technique had helped improve her own health. Ms Boxer worked for advertising agency before starting her business. A researcher on the show had contacted her to ask if she would like to take part.

Entrepreneur and former footballer Gary Neville was so impressed with her pitch he made her an offer in full before the Dragons had a chance to begin asking questions. She said the impact on the business since the show aired had been “bonkers”. “It’s just been a complete whirlwind,” she said.

Acu Seed kit

The tiny beads are a needle-free form of auriculotherapy, designed to stimulate specific points of the ear to address physical and emotional health concerns. “It completely transformed my life alongside lots and lots of other things like diet, lifestyle changes, meditation, breathwork and movement,” said Ms Boxer. She has since had a child and claimed she was fully healed within a year. “It was like a full overhaul of my life,” Ms Boxer said. Her business, Acu Seeds, sells kits for people to use at home and made a £64,000 profit in its first year, she added.

On the Acu Seed website, we learn the following:

Ear seeds are a form of auriculotherapy, which is the stimulation of specific points of the ear to support physical and emotional health concerns. They are a needle-free form of acupuncture that have been used in Traditional Chinese Medicine (TCM) for thousands of years. TCM teaches that the ear is a microsystem of the whole body, where certain points on the ear correspond to different organs or body parts. Energy pathways (or ‘qi’ or vital life energy) pass through the ear and ear seeds stimulate specific points which send an abundant flow of energy to the related organ or area that needs attention. Think of it like reflexology, but for the ears instead of feet.

Ear seeds also create continual, gentle pressure on nerve impulses in the ear which send messages to the brain that certain organs or systems need support. The brain will then send signals and chemicals to the rest of the body to support whatever ailments you’re experiencing, releasing endorphins into the bloodstream, relaxing the nervous system, and naturally soothing pain and discomfort. Some people use ear seeds alongside acupuncture treatments as they may help the effects of acupuncture last longer between sessions.

I am impressed by the lingo used here:

  • support physical and emotional health concerns – the seeds support the concerns but not the health?
  • a needle-free form of acupuncture – sorry, the seeds don’t puncture anything; they exert pressure; therefore it’s called acuPRESSURE.
  • have been used in Traditional Chinese Medicine (TCM) for thousands of years – no, it was invented just a few decades ago by Paul Nogier.
  • TCM teaches that the ear is a microsystem of the whole body – TCM teaches plenty of nonsense but not this one.
  • Energy pathways (or ‘qi’ or vital life energy) pass through the ear –Qi is nothing more than a figment of the imagination of TCM advocates.
  • send an abundant flow of energy to the related organ or area – only if you believe in your own fictional form of physiology.
  • Think of it like reflexology – which btw is also nonsense.
  • nerve impulses in the ear send messages to the brain that certain organs or systems need support – only if you believe in your own fictional form of physiology.
  • The brain will then send signals and chemicals to the rest of the body – only if you believe in your own fictional form of physiology.
  • help the effects of acupuncture last longer – help the non-existing effects of acupuncture last longer?

One the website, we also learn what for which conditions the treatment is effective:

Ear seeds may support a broad spectrum of health concerns including anxiety, stress, headaches, digestion, immunity, focus, sleep and fatigue. Our ear seed kits include the protocol ear maps for these eight health concerns and each protocol uses between 3 to 5 ear seeds. Ear seeds have also been found to support with women’s health issues like menstrual issues, libido, fertility, postpartum issues, inflammation, menopause and weight loss. The ear maps for these issues are given in our women’s health ear seed kit bundles. The specific combination of seed placements will support your chosen health concern. Further issues that they may support with are addiction, pain, tinnitus, vertigo, thyroid health and more.

Here, I am afraid, we might have a major problem:

THERE IS NO GOOD EVIDENCE TO SUPPORT ANY OF THESE CLAIMS!

I thus do wonder whether the venture of Giselle Boxer might be a case for the Advertising Standards Authority.

Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness.

This study investigated the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN.

The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care.

Outcome parameters were evaluated after 8, 16 and 24 wk. They included:

  • neurological scores, such as an 11-point numeric rating scale (NRS) for hypesthesia,
  • neuropathic pain symptom inventory (NPSI),
  • neuropathy deficit score (NDS),
  • neuropathy symptom score (NSS);
  • nerve conduction studies (NCS) as assessed with a handheld point-of-care device.

Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported.

The authors concluded that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.

That “acupuncture may be beneficial” has been known before and presumably was the starting point of the present study. So, why conduct an open, under-powered trial with non-blind assessors and without defining a primary outcome measure?

Could the motivation be to add yet another false-positive study to the literature of acupuncture?

False-positive, you ask?

Yes, let me explain by having a look at the outcome measures:

  • NRS = a subjective endpoint.
  • NPSI = a subjective endpoint.
  • NDS = a subjective endpoint.
  • NSS = a subjective endpoint.
  • NCS = the only objective endpoint.

And what is remarkable about that?

  • Subjective endpoints are likely to respond to placebo effects.
  • Objective endpoints are not likely to respond to placebo effects.

In other words, what the authors of this study have, in fact, confirmed with their study is this:

acupuncture is a theatrical placebo!

He came to my attention via the sad story recently featured here about patients allegedly being harmed or killed in a Swiss hospital for so-called alternative medicine (SCAM). What I then learned about the doctor in charge of this place fascinated me:

Rau states about himself (my translation):

Early on, Dr Rau focused on natural therapies, in particular homeopathy and dietary changes. The healing success of his patients proved him right, so he studied alternative healing methods with leading practitioners. These included orthomolecular medicine, Chinese and Ayurvedic medicine and European holistic medicine. With his wealth of knowledge and over 30 years of experience, Dr Rau formed his own holistic theory of healing: Swiss Biological Medicine – Dr Rau’s Biological Medicine. It is based on the principles of detoxification, nutrition, digestion and sustainable strengthening of the immune system.

Career & studies:

  • Medical studies at the University of Bern
  • Final medical examinations in Switzerland and the USA
  • Subsequent work in rheumatology, internal and general medicine
  • Member of the Swiss Medical Association FMH since 1981
  • 1981 to 1992 conventional physician & medical director of a Swiss spa centre for rheumatology and rehabilitation medicine
  • 1983 to 1992 Doctor at a drug rehabilitation centre
  • 1992 to 2019 Establishment of the Paracelsus Clinic Lustmühle as medical director and partner
  • until 2020 Head of the academic network and training organisation “Paracelsus Academy”

Rau also states this:

  • 2019 mit dem Honorarprofessoren-Titel von der Europäischen Universität in Wien ausgezeichnet (2019, he was awarded the title of homorary professor at the European University in Vienna)

This puzzles me because there is no such institution as the ‘Europäische Universität in Wien’. There is a Central European University but this can hadly be it?!

Now, I am intrigued and see what the ‘honorary professor’ might have published. Sadly, there seems to be nothing on Medline except 2 interviews. In one interview, Rau explains (amongst other things) ‘live blood analysis’, a method that we have repeatedly discussed before (for instance, here and here):

Darkfield microscopy shows a lot. We take 1 drop of blood and look at it under a very large-scale magnification. The blood is life under the glass. Once it’s on the glass, there isn’t oxygen or light or heat. This is a giant stress for the blood. So we see how, over a time, the blood reacts to this stress, and how the blood cells tolerate the stress. You can see the changes. So we take a drop of blood that represents the organism and put it under stress and look at how the cells react to the stress, and then we can see the tolerance and the resistiveness of these cells. Do they have a good cell-membrane face? Do they have good energetic behavior? Do they clot together? Is there a chance for degenerative diseases? Is there a cancerous tendency in this blood? We see tendencies. And that’s what we are interested in, tendencies.

Question: If you saw a cancerous tendency, what would that look like?

Rau: Cancerous tendency is a change in the cells. They get rigid, so to say. They don’t react very well.

Question: And how long does blood live outside the body?

Rau: It can live for several days. But after 1 hour, the blood is already seriously changed. For example, a leukemia patient came to my clinic for another disease. But when we did darkfield, I found the leukemia. We saw that his white blood cells were atypical. Look at this slide—the fact that there are so many white blood cells together is absolutely unusual, and the fact that there are atypical white blood cells. This shows me that the patient has myeloid leukemia. The patient had been diagnosed as having rheumatoid lung pain, but it was absolutely not true. The real cause of his pain was an infiltration of the spinal bone by these lymphocytes.

This is, of course, complete nonsense. As I explained in my blog post, live blood analysis (LBA) is not plausible and there is no evidence to support the claims made for it. It also is by no means new; using his lately developed microscope, Antony van Leeuwenhoek observed in 1686 that living blood cells changed shape during circulation. Ever since, doctors, scientists and others have studied blood samples in this and many other ways.

New, however, is what today’s SCAM practitioners claim to be able to do with LBA. Proponents believe that the method provides information about the state of the immune system, possible vitamin deficiencies, amount of toxicity, pH and mineral imbalance, areas of concern and weaknesses, fungus and yeast infections, as well as just about everything else you can imagine.

LBA is likely to produce false-positive and false-negative diagnoses. A false-positive diagnosis is a condition which the patient does not truly have. This means she will receive treatments that are not necessary, potentially harmful and financially wasteful. A false-negative diagnosis would mean that the patient is told she is healthy, while in fact she is not. This can cost valuable time to start an effective therapy and, in extreme cases, it would hasten the death of that patient. The conclusion is thus clear: LBA is an ineffective, potentially dangerous diagnostic method for exploiting gullible consumers. My advice is to avoid practitioners who employ this technique.

And what does that say about ‘honorary professor’ Rau?

I think I let you answer that question yourself.

 

Mushrooms are somewhat neglected in medical research, I often feel. This systematic review focused on clinical studies testing the effectiveness of mushrooms in cancer care. A total of 39 met the authors’ inclusion criteria. The studies included 12 different mushroom preparations. Some of the findings were encouraging:

  • A survival benefit was reported using Huaier granules (Trametes robiniophila Murr) in 2 hepatocellular carcinoma studies and 1 breast cancer study.
  • A survival benefit was also found in 4 gastric cancer studies using polysaccharide-K (polysaccharide-Kureha; PSK) as an adjuvant therapy.
  • Eleven studies reported a positive immunological response.
  • Quality-of-life (QoL) improvement and/or reduced symptom burden was reported in 14 studies using various mushroom supplements.
  • Most studies reported adverse effects of grade 2 or lower, mainly nausea, vomiting, diarrhea, and muscle pain.

The authors caution that limitations included small sample size and not using randomized controlled trial design. Many of the reviewed studies were observational. Most showed favorable effects of mushroom supplements in reducing the toxicity of chemotherapy, improving QoL, favorable cytokine response, and possibly better clinical outcomes.

The authors concluded that the evidence is inconclusive to recommend the routine use of mushrooms for cancer patients. More trials are needed to explore mushroom use during and after cancer treatment.

The use of mushrooms for medicinal purposes has a long history in many cultures. Some mushrooms are known to be highly poisonous, some have hallucinogenic effects, and some are assumed to have pharmacological effects that have therapeutic potential. Some mushrooms possess pharmacologic properties such as anti-tumour, immunomodulating, antioxidant, cardiovascular, anti-hypercholesterolemic, anti-viral, anti-bacterial, anti-parasitic, anti-fungal, detoxification, hepatoprotective, and anti-diabetic effects.

Many modern medicines were derived from fungi. The best-known example is penicillin; others include several cancer drugs, statins and immunosuppressants. In Traditional Chinese Medicine, numerous herbal mixtures contain mushrooms; examples are reishi, maitake and shiitake which are all assumed to have anti-cancer properties.

As the review authors point out, there is a paucity of clinical trials testing the effectiveness of mushrooms, and the existing studies tend to be of poor quality. At present, most of our knowledge comes from traditional use or test-tube studies. The adverse effects depend on the specific mushroom in question and, can in some instances, be serious.

Considering the potential and the complexity of mycomedicine, I find it surprising to not see much more research into this subject.

NICE helps practitioners and commissioners get the best care to patients, fast, while ensuring value for the taxpayer. Internationally, NICE has a reputation for being reliable and trustworthy. But is that also true for its recommendations regarding the use of acupuncture? NICE currently recommends that patients consider acupuncture as a treatment option for the following conditions:

Confusingly, on a different site, NICE also recommends acupuncture for retinal migraine, a very specific type of migraine that affect normally just one eye with symptoms such as vision loss lasting up to one hour, a blind spot in the vision, headache, blurred vision and seeing flashing lights, zigzag patterns or coloured spots or lines, as well as feeling nauseous or being sick.

I think this perplexing situation merits a look at the evidence. Here I quote the conclusions of recent, good quality, and (where possible) independent reviews:

So, what do we make of this? I think that, on the basis of the evidence:

  • a positive recommendation for all types of chromic pain is not warranted;
  • a positive recommendation for the treatment of TTH is questionable;
  • a positive recommendation for migraine is questionable;
  • a positive recommendation for prostatitis is questionable;
  • a positive recommendation for hiccups is not warranted;
  • a positive recommendation for retinal migraine is not warranted.

But why did NICE issue positive recommendations despite weak or even non-existent evidence?

SEARCH ME!

 

 

.

This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.

Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.

Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.

The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.

Tongxinluo is mixture of various active ingredients, including

  • ginseng,
  • leech,
  • scorpion,
  • Paeonia lactiflora,
  • cicada slough,
  • woodlouse bug,
  • centipede,
  • sandalwood.

With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.

Tongxinluo is by no means a mixture that has not been studied before.

A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.

A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.

A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.

Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.

So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.

Let’s not forget:

if it sound too good to be true, it probably is!

 

This systematic review aimed to assess the impact of Tai Chi on individuals with essential hypertension and to compare the effects of Tai Chi with other therapies. The researchers conducted a systematic literature search of the Medline, Scholar, Elsevier, Wiley Online Library, Chinese Academic Journal (CNKI) and Wanfang databases from January 2003 to August 2023. Using the methods of the Cochrane Collaboration Handbook, a meta-analysis was conducted to assess the collective impact of Tai Chi exercise in controlling hypertension. The primary outcomes measured included blood pressure and nitric oxide levels.

A total of 32 RCTs were included. The participants consisted of adults with an average age of 57.1 years who had hypertension (mean ± standard deviation systolic blood pressure at 148.2 ± 12.1 mmHg and diastolic blood pressure at 89.2 ± 8.3 mmHg). Individuals who practiced Tai Chi experienced reductions in systolic blood pressure of 10.6 mmHg, diastolic blood pressure of 4.7 mmHg and an increase in nitric oxide levels.

The authors concluded that Tai Chi can be a viable lifestyle intervention for managing hypertension. Greater promotion of Tai Chi by medical professionals could extend these benefits to a larger patient population.

Tai Chi allegedly incorporates principles rooted in the Yin and Yang theory, Chinese medicine meridians and breathing techniques, and creates a unique form of exercise characterized by its inward focus, continuous flow, the balance of strength and gentleness, and alternation between fast and slow movements.  What sets Tai Chi apart from other forms of excercise is the requirement for mindful guidance during practice. This aspect may, according to the authors, be the reason why Tai Chi also outperforms general aerobic exercise in managing hypertension.

I can well imagine that any form of relaxation reduces blood pressure. What I find hard to believe is that Tai Chi is better than any other relaxing SCAMs. The 32 RCTs included in this new review fail to impress me because they are all from China, and – as we have often mentioned before – studies from China are to be taken with a pinch of salt.

Yet, the subject is important enough, in my view, to merit a few rigorous trials conducted by independent researchers. Until such data are available, I think, I prefer to rely on our own systematic review which conculded that the evidence for tai chi in reducing blood pressure … is limited. Whether tai chi has benefits over exercise is still unclear. The number of trials and the total sample size are too small to draw any firm conclusions.

 

 

 

This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.

A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.

The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.

As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:

  • regression towards the mean;
  • natural history of the condition;
  • success of patient blinding;
  • social desirability.

To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.

In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.

My ‘ALTERNATIVE MEDICINE HALL OF FAME‘ (the group of people who have managed to publish nothing but positive findings about a dubious therapy) currently consists of 20 members (unless I have forgotten somone, which is possible, of course):

  1. Jorge Vas (acupuncture, Spain)
  2. Wane Jonas (homeopathy, US)
  3. Harald Walach (various SCAMs, Germany)
  4. Andreas Michalsen ( various SCAMs, Germany)
  5. Jennifer Jacobs (homeopath, US)
  6. Jenise Pellow (homeopath, South Africa)
  7. Adrian White (acupuncturist, UK)
  8. Michael Frass (homeopath, Austria)
  9. Jens Behnke (research officer, Germany)
  10. John Weeks (editor of JCAM, US)
  11. Deepak Chopra (entrepreneur, US)
  12. Cheryl Hawk (US chiropractor)
  13. David Peters (osteopathy, homeopathy, UK)
  14. Nicola Robinson (TCM, UK)
  15. Peter Fisher (homeopathy, UK)
  16. Simon Mills (herbal medicine, UK)
  17. Gustav Dobos (various SCAMs, Germany)
  18. Claudia Witt (homeopathy, Germany/Switzerland)
  19. George Lewith (acupuncture, UK)
  20. John Licciardone (osteopathy, US)

Today, it is time to add the 21st member. My last post was about a weird study co-authored by someone who struck me as truly remarkable. Terry Oleson is employed by the Department of Traditional Oriental Medicine, Emperor’s College of Traditional Oriental Medicine, Santa Monica, CA, USA. On ‘research gate‘, he describes his expertise as follows:

  • Cognitive Psychology
  • Clinical Psychology
  • Biological Psychology
  • Clinical Trials
  • Addiction Medicine
  • Allied Health Science

Oleson received his BA in Biology from the University of California, Santa Barbara, in 1967, his MA in Psychology from California State University at Long Beach in 1971, and his PhD from UC Irvine in 1973. He went on to conduct a postdoctoral scholarship at UCLA at that time, where he conducted pioneering research in auricular diagnosis and auriculotherapy. Since many years, Oleson has published on auricular acupuncture and acupressure, at least one book and the papers listed below. This is an oddly dubious and biologically implausible so-called alternative medicine (SCAM). Terry Oleson – whom I never knowingly met in person – and his research are all the more remarkable: in his hands auricular therapy seems to work of just about everything:

  1. Effect of auricular acupressure on postpartum blues: A randomized sham controlled trial. Alimoradi Z, Asgari S, Barghamadi S, Hajnasiri H, Oleson T, Griffiths MD.Complement Ther Clin Pract. 2023 Aug;52:101762. doi: 10.1016/j.ctcp.2023.101762. Epub 2023 Apr 10.PMID: 37060791
  2. Auriculotherapy stimulation for neuro-rehabilitation.  Oleson T.NeuroRehabilitation. 2002;17(1):49-62.PMID: 12016347
  3. Acupuncture: the search for biologic evidence with functional magnetic resonance imaging and positron emission tomography techniques. Cho ZH, Oleson TD, Alimi D, Niemtzow RC.J Altern Complement Med. 2002 Aug;8(4):399-401. doi: 10.1089/107555302760253577.PMID: 12230898
  4. Commentary on auricular acupuncture for cocaine abuse. Oleson TD.J Altern Complement Med. 2002 Apr;8(2):123-5. doi: 10.1089/107555302317371406.PMID: 12013511
  5. Clinical Commentary on an Auricular Marker Associated with COVID-19. Oleson T, Niemtzow RC, Pock A.Med Acupunct. 2020 Aug 1;32(4):176-177. doi: 10.1089/acu.2020.29152.com. Epub 2020 Aug 13.PMID: 32913483
  6. Comparison of Auricular Therapy with Sham in Children with Attention Deficit/Hyperactivity Disorder: A Randomized Controlled Trial. Binesh M, Daghighi MR, Shirazi E, Oleson T, Hashem-Dabaghian F.J Altern Complement Med. 2020 Jun;26(6):515-520. doi: 10.1089/acm.2019.0477. Epub 2020 May 20.PMID: 32434376
  7.  Application of Polyvagal Theory to Auricular Acupuncture.Oleson T.Med Acupunct. 2018 Jun 1;30(3):123-125. doi: 10.1089/acu.2018.29085.tol.PMID: 29937963
  8. The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial. Barghamadi S, Alimoardi Z, Oleson T, Bahrami N.Trials. 2020 Aug 20;21(1):729. doi: 10.1186/s13063-020-04663-x.PMID: 32819441
  9.  Randomized controlled study of premenstrual symptoms treated with ear, hand, and foot reflexology. Oleson T, Flocco W.Obstet Gynecol. 1993 Dec;82(6):906-11.PMID: 8233263
  10. Auricular electrical stimulation and dental pain threshold. Simmons MS, Oleson TD.Anesth Prog. 1993;40(1):14-9.PMID: 8185085
  11. Rapid narcotic detoxification in chronic pain patients treated with auricular electroacupuncture and naloxone. Kroening RJ, Oleson TD.Int J Addict. 1985 Sep;20(9):1347-60. doi: 10.3109/10826088509047771.PMID: 2867052
  12. Investigation of the effects of naloxone upon acupuncture analgesia. Oleson TD.Pain. 1984 Jun;19(2):201-4. doi: 10.1016/0304-3959(84)90872-8.PMID: 6462730
  13.  Electroacupuncture & auricular electrial stimulation. Oleson TD, Kroening RJ.IEEE Eng Med Biol Mag. 1983;2(4):22-6. doi: 10.1109/MEMB.1983.5005987.PMID: 19493718
  14. An experimental evaluation of auricular diagnosis: the somatotopic mapping or musculoskeletal pain at ear acupuncture points. Oleson TD, Kroening RJ, Bresler DE.Pain. 1980 Apr;8(2):217-229. doi: 10.1016/0304-3959(88)90009-7.PMID: 7402685

14 papers about a dodgy SCAM without the hint of a negative finding! I hope we can all agree that this achievement makes Terry a worthy member of my ‘HALL OF FAME’, a group of people who, like Terry, have been able to publish nothing but positive findings about the most dubious SCAMs.

Welcome Terry!

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories