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

TCM

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The objective of this trial, just published in the BMJ, was to assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura. The study was designed as a multi-centre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician. It was conducted in 7 hospitals in China with 150 acupuncture naive patients with episodic migraine without aura.

They were given the following treatments:

  • 20 sessions of manual acupuncture at true acupuncture points plus usual care,
  • 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care,
  • usual care alone over 8 weeks.

The main outcome measures  were change in migraine days and migraine attacks per 4 weeks during weeks 1-20 after randomisation compared with baseline (4 weeks before randomisation).

A total of 147 were included in the final analyses. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham. No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%).

The authors concluded that twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.

Considering the many flaws in most acupuncture studies discussed ad nauseam on this blog, this is a relatively rigorous trial. Yet, before we accept the conclusions, we ought to evaluate it critically.

The first thing that struck me was the very last sentence of its abstract. I do not think that a single trial can ever be a sufficient reason for changing existing guidelines. The current Cochrance review concludes that the available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Thus, one could perhaps argue that, together with the existing data, this new study might strengthen its conclusion.

In the methods section, the authors state that at the end of the study, we determined the maintenance of blinding of patients by asking them whether they thought the needles had penetrated the skin. And in the results section, they report that they found no significant difference between the manual acupuncture and sham acupuncture groups for patients’ ability to correctly guess their allocation status.

I find this puzzling, since the authors also state that they tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. They fail to report data on this but this attempt is usually successful in the majority of patients. In the control group, where non-penetrating needles were used, no de-qi could be generated. This means that the two groups must have been at least partly de-blinded. Yet, we learn from the paper that patients were not able to guess to which group they were randomised. Which statement is correct?

This may sound like a trivial matter, but I fear it is not.

Like this new study, acupuncture trials frequently originate from China. We and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. If that is so, one does not need to read the paper, one already knows that it is positive before one has even seen it. Neither do the researchers need to conduct the study, one already knows the result before the trial has started.

You don’t believe the findings of my research nor those of others?

Excellent! It’s always good to be sceptical!

But in this case, do you believe Chinese researchers?

In this systematic review, all RCTs of acupuncture published in Chinese journals were identified by a team of Chinese scientists. An impressive total of 840 trials were found. Among them, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.

So, at least three independent reviews have found that Chinese acupuncture trials report virtually nothing but positive findings. Is that enough evidence to distrust Chinese TCM studies?

Perhaps not!

But there are  even more compelling reasons for taking evidence from China with a pinch of salt:

A survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations. “Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Chinese research organisations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

So, am I claiming the new acupuncture study just published in the BMJ is a fake?

No!

Am I saying that it would be wise to be sceptical?

Yes.

Sadly, my scepticism is not shared by the BMJ’s editorial writer who concludes that the new study helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence based treatment.

Call me a sceptic, but that statement is, in my view, hard to justify!

 

The ‘Corona-Virus Quackery Club’ (CVQC) is enjoying a fast-growing membership. As mentioned in previous posts, it consists of:

homeopaths,

colloidal silver crooks,

TCM practitioners,

orthomolecular quacks,

Unani-salesmen.

Chiropractors have been keen to join since weeks. They have a long tradition of claiming that their ‘adjustments’ boost the immune system, and therefore it was to be expected that they also jump on the corona-bandwagon.

Some chiropractors seem to believe that the corona-virus pandemic is a fine business opportunity or, as one put it, the perfect opportunity to have a heart to heart with patients about their immune and nervous systems! Remember, if germs automatically caused disease, the human race wouldn’t be around to debate the issue. Many forget that Louis Pasteur, the father of the germ theory recanted his belief. On his deathbed he observed, “It’s the soil, not the seed.” In other words, without the right environment, germs can do little harm.

Chiropractors and other health care workers are at greater risk due to patient or client interactions and are encouraged to take extra precautions when it comes to cleaning and disinfecting surfaces and skin or close contact.

“Every chiropractic practice has been touched by coronavirus [fears],” says Bill Esteb, DC, who has created and is circulating a coronavirus and chiropractic guide on how to avoid contracting the virus.

“We wanted to create a tool that chiropractors could use as a conversation springboard. Chiropractors need to remind their patients that germs don’t automatically cause disease. And that ‘catching’ the coronavirus, or anything else, requires a hospitable environment.”

The only way to catch anything, says Esteb, is to become a hospitable host. Flipping the message, Esteb in his coronavirus and chiropractic guide says here is “How to Catch the Coronavirus”:

  • Eat a Poor Diet — Make sure your body lacks the vitamins, minerals, enzymes and micronutrients needed to keep itself in good repair.
  • Avoid Adequate Rest — Stay up late and use sugar, tobacco, coffee and energy drinks as needed.
  • Become Dehydrated — Reduce the effectiveness of your natural defense mechanisms by shunning adequate water.
  • Stop Exercising — Reduce the efficiency of your lymphatic system, which requires movement to circulate this important germ-fighting fluid.
  • Think Negative Thoughts — Worry that you’ll be a victim. Closely monitor news reports about outbreaks, fearing the advancing pandemic.
  • Rarely Wash Your Hands — Use your dirty hands and fingers to rub your eyes, pick your nose or wipe your lips.
  • Skip Your Chiropractic Adjustments — Handicap your nervous system, the master system that controls your entire body. Wait until symptoms are clearly present.

“Following these suggestions is the way to become a suitable host for any number of germs or microbes,” Esteb says. “The tongue-in-check approach keeps the subject light. It stimulates more instructive patient conversations. It helps reduce appointment cancellations.

“Most people have an inappropriate fear of germs. And while this poster and patient handout won’t eliminate it, use it to explore the value of ongoing chiropractic care as a preventive strategy.”

——–

The Internet is full with messages of this type. Here is just one example: The best defense for the Corona Virus is to be healthy when you are exposed to the virus. Get adjusted to boost your immune system. Check out this video blog on what you can do to be healthy and prepare your body to fight off the corona virus.

——–

Perhaps the worst excesses can be found on Twitter:

James Langford 
@JamesLangford15·

Did you know that a properly aligned body supports and activates our immune system. During this time of concern from the corona virus, making sure your body is healthy is the best way to combat this illness. #health #immunesystem
Oxford Chiropractic
@OxfordChiropra1·

Scared of the corona virus? Practice a little preventative care like mama always used to tell you and get your spine adjusted!!! It’s boosts your immune by 200%!!!!! Why aren’t we talking… instagram.com/p/B9pjMqdATmBn
——–
So, considering this concerted effort, I am happy to announce that, from today, my friends the chiros are official members of the CVQC.
CONGRATULATIONS GUYS!
PS
Whether Boris Johnson will be allowed in, depends on future announcements; so far, his chances are not bad.

It has been reported that, in China, patients affected by the coronavirus are being treated with Traditional Chinese Medicine (TCM). Treatments in Wuhan hospitals combine TCM and western medicines, said Wang Hesheng, the new health commission head in Hubei, the province at the centre of the epidemy. He said TCM was applied on more than half of confirmed cases in Hubei. “Our efforts have shown some good result,” Wang said at a press conference on Saturday. Top TCM-experts have been sent to Hubei for “research and treatment,” he said. Some 2,200 TCM workers have been sent to Hubei, Wang said.

Another website confirmed that TCM has been applied to more than half of the confirmed patients of corona or COVID-19 infection in Hubei. It’s also used in the prevention and control of COVID-19 at the community level. “Since the beginning of the outbreak, the government has attached importance to both TCM and Western medicine by mobilizing the strongest scientific research and medical forces in both fields to treat the patients,” said Wang Hesheng. “By coordinating the resources of traditional Chinese and Western medicine, we strive to improve the cure rate and reduce fatalities by the greatest possible amount to effectively safeguard the safety and health of the people,” Wang noted.

China Daily added that many of the medical workers also have participated in the fight against the SARS outbreak in 2003, said Huang Luqi, president of China Academy of Chinese Medical Sciences. Three national-level TCM teams, organized by the National Administration of Traditional Chinese Medicine, also have been dispatched to Hubei, said Huang, head of the TCM team at Wuhan Jinyintan Hospital.

The TCM workers have treated 248 confirmed and suspected novel coronavirus patients, and 159 of them have shown improvement and 51 have been discharged from the hospital, Huang said at a daily news conference in Wuhan. More than 75 percent of novel coronavirus patients in Hubei, and more than 90 percent of patients in other regions of the country, have received TCM treatment, he said. “We hope that Hubei province and Wuhan city can increase the use of TCM in treating confirmed and suspected novel coronavirus patients,” Huang said. TCM can shorten the course of disease for patients with severe symptoms, reduce the possibility of mild infections becoming severe, help with patient recovery and disease prevention and offer psychological support to patients, he noted.

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No information is available on the nature of the TCM treatments used. Moreover, the reported response rate (159 of 248) sounds far from encouraging to me. In fact, it could reflect merely the natural history of the disease or might even hide a detrimental effect of TCM on the infection. What we need are controlled studies, without them, reports like the ones above are mere useless and potentially harmful propaganda for boosting China’s TCM-trade.

The University College London Hospitals (UCLH) include the ‘Royal London Hospital for Integrated Medicine’ (RLHIM). The RLHIM offers a range of so-called alternative medicines (SCAMs), including acupuncture.

This is how they advertise traditional acupuncture to the unsuspecting public:

Acupuncture is a part of Traditional Chinese Medicine (TCM). This is a system of healing which has been practised in China and other Eastern countries for thousands of years.

Although often used as a means of pain relief, it can treat people with other illnesses. The focus is on improving the overall well-being of the patient, rather than the isolated treatment of specific symptoms.

You will be seen individually and assessed by an acupuncturist trained in TCM. They will use traditional Chinese techniques including pulse, tongue and abdominal diagnosis. They will also ask you about your medical history and lifestyle.

The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance.

The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs. It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms.

We will assess your individual needs and discuss a treatment plan with you during your initial consultation.

The treatment may include the use of the following:

  • The use of fine acupuncture needles
  • Moxibustion (burning of the herb mugwort close to the surface of the skin)
  • Cupping therapy (to create local suction on the skin)
  • Acupressure (pressure applied to acu-points to stimulate energy flow)
  • Electro-acupuncture (a low voltage current is passed between 2 needles)

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How reliable is this information? I will try to answer this question by discussing the 6 statements that, in my view, are most questionable.

Although often used as a means of pain relief, it can treat people with other illnesses

Whether acupuncture is effective for pain relief is debatable. A recent analysis cast considerable doubt on the assumption. The notion that acupuncture ‘can treat people with other illnesses’ seems like a ‘carte blanche’ for treating virtually any condition regardless of evidence.

Improving the overall well-being of the patient

I am not aware of sound evidence that acupuncture is an effective treatment for improving overall well-being.

Traditional Chinese techniques including pulse, tongue and abdominal diagnosis

These diagnostic techniques have not been adequately validated and have no place in evidence-based healthcare.

The TCM trained acupuncturist can stimulate the body’s own healing response and help to restore its natural balance

I am not aware of sound evidence to show that acupuncture stimulates healing. The statement seems like another ‘carte blanche’ for treating anything the therapist feels like, regardless of evidence.

The principal aim of acupuncture in treating the whole person is to create balance between your physical, emotional and spiritual needs

The claim that acupuncture is a holistic treatment is based on little more than wishful thinking by acupuncturists.

It can help to relax, improve mood and sleep, relieve tension and improve your sense of well-being, as well as improving symptoms

I am not aware of sound evidence that acupuncture is effective in treating any of the named conditions. The end of the sentence (‘as well as improving symptoms’) is another ‘carte blanche’ for doing anything the acupuncturists feels like.

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The UCLH are firmly committed to EBM. The RLHIM claims to be ‘a centre for evidence-based practice’. This claim is not supported by the above advertisement of acupuncture which is clearly not based on good evidence. Moreover, it has the potential to mislead vulnerable patients and thus cause considerable harm. In my view, it is high time that the UCLH address this problem.

The aim of this review is to synthesise systematic reviews (SRs) of randomised clinical trials (RCTs) evaluating the efficacy of acupuncture to alleviate chronic pain. A total of 177 reviews of acupuncture from 1989 to 2019 met the eligibility criteria. The majority of SRs found that RCTs of acupuncture had methodological shortcomings, including inadequate statistical power with a high risk of bias. Heterogeneity between RCTs was such that meta-analysis was often inappropriate.

Having (co-) authored 13 of these SRs myself, I am impressed with the amount of work that went into this synthesis. The authors should be congratulated for doing it – and for doing it well! The paper itself differentiates the findings according to various types of pain. Here I reproduce the authors’ conclusion regarding different pain entities:

  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for chronic pain associated with various medical conditions. There is no specific NICE guidance about the use of acupuncture for chronic pain conditions irrespective of aetiology or pathophysiology, although some guidance exists for specific pain conditions (see respective sections below). Guidance by NICE on chronic pain assessment and management is currently being developed (GIDNG10069) with publication expected in August 2020.
  • Evidence from the SRs suggests that acupuncture prevents episodic or chronic tension‐type headaches and episodic migraine, although long‐term studies and studies comparing acupuncture with other treatment options are still required. The current NICE guidance (clinical guideline CG150) is that a course of up to 10 sessions of acupuncture over 5–8 weeks is recommended for tension‐type headache and migraine.
  • The most recent evidence from a Cochrane review of 16 RCTs suggests that acupuncture is not superior to sham acupuncture for OA of the hip, although in contrast, evidence from nonCochrane reviews suggests that there is moderate‐quality evidence that acupuncture may be effective in the symptomatic relief of pain from OA of the knee. Why there should be a difference in evidence between the knee and the hip is not known. Interestingly, guidance from NICE (CG177) states: “Do not offer acupuncture for the management of osteoarthritis”.
  • Evidence suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for low back pain. In 2009, NICE published guidance for the management of nonspecific low back pain that recommended a course of acupuncture as part of first line treatment. This guidance produced much debate. Subsequently, NICE have updated guidance for the management of low back pain and sciatica in people over 16 (NG59) and currently recommend in Section 1.2.8 “Do not offer acupuncture for managing low back pain with or without sciatica”, even though the evidence had not significantly changed.
  • Evidence from SRs suggests that dry needling acupuncture might be effective in alleviating pain associated with myofascial trigger points, at least in the short‐term, although there are insufficient high‐quality RCTs to judge the efficacy with any degree of certainty. There is no guidance from NICE on the management of myofascial pain syndrome.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain and more high‐quality, appropriately designed and adequately powered studies are needed. The most recent guidance from NICE (CSG4) recognises that patients who are receiving palliative care often seek complementary therapies, but it does not specifically recommend acupuncture. It recognises that “Many studies have a considerable number of methodological limitations, making it difficult to draw definitive conclusions”.
  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for fibromyalgia pain. There is no NICE guidance on the treatment of fibromyalgia.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for primary dysmenorrhea or chronic pelvic pain. There is NICE guidance on endometriosis (NG73) [200] but this does not recommend any form of Chinese medicine for this type of pelvic pain, although acupuncture is not specifically mentioned.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for pain in inflammatory arthritis. There is a NICE guideline (NG100) [201] for the treatment of rheumatoid arthritis but this does not recommend acupuncture.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for neuropathic pain or neuralgia. There is NICE guidance (CG173) on the management of neuropathic pain, but acupuncture is not included in the list of recommended/not recommended treatments.
  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for a variety of other painful conditions, including lateral elbow pain, shoulder pain and labour pain. There is no guidance available from NICE on the treatment of any of these conditions.

So, what should we make of all this?

Maybe I just point out two things:

  1. This is a most valuable addition to the literature about acupuncture. It can serve as a reference for all who are interested in an honest account of the (lack of) value of acupuncture in the management of chronic pain.
  2. If a therapy has been tested in hundreds of (sadly often flawed) trials and the conclusions fail to come out clearly in favour of it, it is most likely not a very effective treatment.

Until we have data to the contrary, acupuncture should not be considered to be an effective therapy for chronic pain management.

Realgar, α-As4S4, is an arsenic sulfide mineral, also known as “ruby sulphur” or “ruby of arsenic”. It is a soft, sectile mineral occurring in monoclinic crystals, or in granular, compact, or powdery form, often in association with the related mineral, orpiment (As2S3).

In Traditional Chinese Medicine (TCM), realgar is often used in combination with herbs. An investigation found a total of 191 different, realgar-containing traditional Chinese patent medicines, and about 87% of them were for oral application. Realgar is said to: 

counteract toxic pathogen both externally and internally. For abscess swelling and sores, it can be used singly or in compound prescription for external application mostly. When taken internally, it is combined with blood-activating and abscess-curing herbs to obtain the action of activating blood to relieve swelling, removing toxicity to cure sores. For example, it is combined with Ru Xiang, Mo Yao and She Xiang in Xing Xiao Wan from Wai Ke Quan Sheng Ji. For itching of skin due to scabies and ringworm, it is often combined with dampness-astringing and itching-relieving herbs to obtain actions of killing parasites and curing ringworm, astringing dampness and relieving itching. For instance, it is combined with the same dose of Bai Fan in powder mixed with clear tea for external application in Er Wei Ba Du San from Yi Zong Jin Jian. For poisonous insect bite, it is mixed with sesame oil and then applied on the afflicted sites.

This herb can kill parasites so it is indicated for intestine track parasites. For roundworm induced abdominal pain, it is often combined with other roundworm-killing herbs to reinforce action. For instance, it is combined with Qian Niu Zi and Bing Lang, etc. in Qian Niu Wan from Shen Shi Zun Sheng Shu. For anus pruritus caused by pinworm, it can be made into gauze strip by mixing with vaseline, and then inserted into the anus.

In addition, according to some ancient formulas, this herb can dispel phlegm and check malaria for internal application, so it can also be indicated for epilepsy, asthma and malaria.

Longtime topical over-dose or oral intake of realgar can cause chronic arsenic poisoning and even death. Chinese authors recently published the case of a 35-year-old Chinese man, who was diagnosed with severe psoriasis and died of fatal acute arsenic poisoning after he applied a local folk prescription ointment containing mainly realgar to the affected skin for about 4 days. The autopsy showed multiple punctate haemorrhages over the limbs, pleural effusion, oedematous lungs with consolidation, mild myocardial hypertrophy and normal-looking kidneys. The histopathological examination of renal tissue showed severe degeneration, necrosis and desquamation of renal tubular epithelial cells, presence of protein cast and a widened oedematous interstitium with interstitial fibrosis. The presence of arsenic in large amount in the ointment (about 6%), in blood (1.76 μg/mL), and in skin (4.71 μg/g), were confirmed analytically. The authors also review 7 similar cases in literature.

My advice is that, when you see recommendations by TCM practitioners like this one

the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically

you think again and consider that TCM really is not a form of healthcare that can be trusted to be safe.

Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Acupuncture is often recommended, but does it work? This study was aimed at finding out whether acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.

The 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centres in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Either TA or SA using a validated acupuncture placebo device were performed 3 times per week during a 6- to 7-week course of radiation therapy. The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.

Of 399 patients randomized, 339 were included in the final analysis, including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).

The authors concluded that this randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.

In essence this two-centre study shows that:

  • real acupuncture is better than usual care, but the effect size is small and of doubtful clinical relevance;
  • real acupuncture is not significantly better than sham acupuncture;
  • the findings differ remarkably between the US and the Chinese centre.

I find the last point the most interesting one. We know from previous research that acupuncture studies from China are notoriously unreliable; they never report a negative result and there is evidence that data fabrication is rife in China. The new findings seems to throw more light on this notion. In the US centre, real and sham acupuncture generated practically identical results. By contrast, in the Chinese centre, real acupuncture generated significantly better results than sham. The authors offer several hypotheses to explain this remarkable phenomenon. Yet, in my view, the most likely one is that Chinese researchers are determined to show that acupuncture is effective. Thus all sorts of unconscious or even conscious biases might get introduced into such studies.

In essence, trial therefore confirms that acupuncture is little more than a theatrical placebo, particularly if we consider the US data which, in my opinion, are more trustworthy.

Lorenzo Cohen, Professor of Palliative, Rehabilitation, and Integrative Medicine and director of the Integrative Medicine Program as well as senior author of the paper unsurprisingly disagrees. He was quoted saying: “The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms. I think with this study we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”

Who do you think is closer to the truth?

The medical literature is currently swamped with reviews of acupuncture (and other forms of TCM) trials originating from China. Here is the latest example (but, trust me, there are hundreds more of the same ilk).

The aim of this review was to evaluate the effectiveness of scalp, tongue, and Jin’s 3-needle acupuncture for the improvement of post-apoplectic aphasia. PubMed, Cochrane, Embase databases were searched using index words to identify qualifying randomized controlled trials (RCTs). Meta-analyses of odds ratios (OR) or standardized mean differences (SMD) were performed to evaluate the outcomes between investigational (scalp / tongue / Jin’s 3-needle acupuncture) and control (traditional acupuncture; TA and/or rehabilitation training; RT) groups.

Thirty-two RCTs (1310 participants in investigational group and 1270 in control group) were included. Compared to TA, (OR 3.05 [95% CI: 1.77, 5.28]; p<0.00001), tongue acupuncture (OR 3.49 [1.99, 6.11]; p<0.00001), and Jin’s 3-needle therapy (OR 2.47 [1.10, 5.53]; p = 0.03) had significantly better total effective rate. Compared to RT, scalp acupuncture (OR 4.24 [95% CI: 1.68, 10.74]; p = 0.002) and scalp acupuncture with tongue acupuncture (OR 7.36 [3.33, 16.23]; p<0.00001) had significantly better total effective rate. In comparison with TA/RT, scalp acupuncture, tongue acupuncture, scalp acupuncture with tongue acupuncture, and Jin’s three-needling significantly improved ABC, oral expression, comprehension, writing and reading scores.

The authors concluded that compared to traditional acupuncture and/or rehabilitation training, scalp acupuncture, tongue acupuncture, and Jin’ 3-needle acupuncture can better improve post-apoplectic aphasia as depicted by the total effective rate, the ABC score, and comprehension, oral expression, repetition, denomination, reading and writing scores. However, quality of the included studies was inadequate and therefore further high-quality studies with lager samples and longer follow-up times and with patient outcomes are necessary to verify the results presented herein. In future studies, researchers should also explore the efficacy and differences between scalp acupuncture, tongue acupuncture and Jin’s 3-needling in the treatment of post-apoplectic aphasia.

I’ll be frank: I find it hard to believe that sticking needles in a patient’s tongue restores her ability to speak. What is more, I do not believe a word of this review and its conclusion. And now I better explain why.

  • All the primary studies originate from China, and we have often discussed how untrustworthy such studies are.
  • All the primary studies were published in Chinese and cannot therefore be checked by most readers of the review.
  • The review authors fail to provide the detail about a formal assessment of the rigour of the included studies; they merely state that their methodological quality was low.
  • Only 6 of the 32 studies can be retrieved at all via the links provided in the articles.
  • As far as I can find out, some studies do not even exist at all.
  • Many of the studies compare acupuncture to unproven therapies such as bloodletting.
  • Many do not control for placebo effects.
  • Not one of the 32 studies reports findings that are remotely convincing.

I conclude that such reviews are little more than pseudo-scientific propaganda. They seem aim at promoting acupuncture in the West and thus serve the interest of the People’s Republic of China. They pollute our medical literature and undermine the trust in science.

I seriously ask myself, are the editors and reviewers all fast asleep?

The journal ‘BMC Complement Altern Med‘  has, in its 18 years of existence, published almost 4 000 Medline-listed papers. They currently charge £1690 for handling one paper. This would amount to about £6.5 million! But BMC are not alone; as I have pointed out repeatedly, EBCAM is arguably even worse.

And this is, in my view, the real scandal. We are being led up the garden path by people who make a very tidy profit doing so. BMC (and EBCAM) must put an end to this nonsense. Alternatively, PubMed should de-list these publications.

This has been going on for far too long; urgent action is required!

 

Traditional Chinese Medicine (TCM) is a term created by Mao lumping together various modalities in an attempt to pretend that healthcare in the People’s Republic of China (PRC) was being provided despite the most severe shortages of conventional doctors, drugs and facilities. Since then, TCM seems to have conquered the West, and, in the PRC, the supply of conventional medicine has hugely increased. Today therefore, TCM and conventional medicine peacefully co-exist side by side in the PRC on an equal footing.

At least this is what we are being told – but is it true?

I have visited the PRC twice. The first time, in 1980, I was the doctor of a university football team playing several games in the PRC, including one against their national team. The second time, in 1991, I co-chaired a scientific meeting in Shanghai. On both occasions, I was invited to visit TCM facilities and discuss with colleagues issues related to TCM in the PRC. All the official discussions were monitored by official ‘minders’, and therefore fee speech and an uninhibited exchange of ideas are not truly how I would describe them. Yet, on both visits, there were occasions when the ‘minders’ were absent and a more liberal discussion could ensue. Whenever this was the case, I did not at all get the impression that TCM and conventional medicine were peacefully co-existing. The impression that I did get was that their co-existence resembled more a ‘shot-gun marriage’.

During my time running the SCAM research unit at Exeter, I had the opportunity to welcome several visiting researchers from the PRC. This experience seemed to confirm my impression that TCM in the PRC was less than free. As an example, I might cite one acupuncture project I was once working on with a scientist from the PRC. When it was nearing its conclusion and I mentioned that we should now think about writing it up to publish the findings, my Chinese colleague said that being a co-author was unfortunately not an option. Knowing how important publications in Western journals are for researchers from the PRC, I was most surprised by this revelation. The reason, it turned out, was that our findings failed to be favourable for TCM. My friend explained that such a paper would not advance but hinder an academic career, once back in the PRC.

Suspecting that the notion of a peaceful co-existence of TCM and conventional medicine in the PRC was far from true, I have always been puzzled how the myth could survive for so many years. Now, finally, it seems to crumble. This is from a recent journalistic article entitled ‘Chinese Activists Protest the Use of Traditional Treatments – They Want Medical Science’ which states that thousands of science activists in the PRC protest that the state neglects its duty to treat its citizens with evidence-based medicine (here is the scientific article this is based on):

Over a number of years, Chinese researcher Qiaoyan Zhu, who has been affiliated with the University of Copenhagen’s Department of Communication, has collected data on the many thousand science activists in China through observations in Internet forums, on social media and during physical meetings. She has also interviewed hundreds of activists. Together with Professor Maja Horst, who has specialized in research communication, she has analyzed the many data on the activists and their protests in an article that has just been published in the journal Public Understanding of Science:

“The activists are better educated and wealthier than the average Chinese population, and a large majority of them keep up-to-date with scientific developments. The protests do not reflect a broad popular movement, but the activists make an impact with their communication at several different levels,” Maja Horst explained and added: “Many of them are protesting individually by writing directly to family, friends and colleagues who have been treated with – and in some cases taken ill from – Traditional Chinese Medicine. Some have also hung posters in hospitals and other official institutions to draw attention to the dangers of traditional treatments. But most of the activism takes place online, on social media and blogs.

Activists operating in a regime like the Chinese are obviously not given the same leeway as activists in an open democratic society — there are limits to what the authorities are willing to accept in the public sphere in particular. However, there is still ample opportunity to organize and plan actions online.

“In addition to smaller groups and individual activists that have profiles on social media, larger online groups are also being formed, in some cases gaining a high degree of visibility. The card game with 52 criticisms about Traditional Chinese Medicine that a group of activists produced in 37,000 copies and distributed to family, friends and local poker clubs is a good example. Poker is a highly popular pastime in rural China so the critical deck of cards is a creative way of reaching a large audience,” Maja Horst said.

Maja Horst and Qiaoyan Zhu have also found examples of more direct action methods, where local activist groups contact school authorities to complain that traditional Chinese medicine is part of the syllabus in schools. Or that activists help patients refuse treatment if they are offered treatment with Traditional Chinese Medicine.

________________________________________________________________

I am relieved to see that, even in a system like the PRC, sound science and compelling evidence cannot be suppressed forever. It has taken a mighty long time, and the process may only be in its infancy. But there is hope – perhaps even hope that the TCM enthusiasts outside the PRC might realise that much of what came out of China has led them up the garden path!?

 

On this blog, we have often noted that (almost) all TCM trials from China report positive results. Essentially, this means we might as well discard them, because we simply cannot trust their findings. While being asked to comment on a related issue, it occurred to me that this might be not so much different with Korean acupuncture studies. So, I tried to test the hypothesis by running a quick Medline search for Korean acupuncture RCTs. What I found surprised me and eventually turned into a reminder of the importance of critical thinking.

Even though I found pleanty of articles on acupuncture coming out of Korea, my search generated merely 3 RCTs. Here are their conclusions:

RCT No1

The results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.

RCT No2

The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies.

RCT No3

Bee venom acupuncture combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

So yes, according to this mini-analysis, 100% of the acupuncture RCTs from Korea are positive. But the sample size is tiny and I many not have located all RCTs with my ‘rough and ready’ search.

But what are all the other Korean acupuncture articles about?

Many are protocols for RCTs which is puzzling because some of them are now so old that the RCT itself should long have emerged. Could it be that some Korean researchers publish protocols without ever publishing the trial? If so, why? But most are systematic reviews of RCTs of acupuncture. There must be about one order of magnitude more systematic reviews than RCTs!

Why so many?

Perhaps I can contribute to the answer of this question; perhaps I am even guilty of the bonanza.

In the period between 2008 and 2010, I had several Korean co-workers on my team at Exeter, and we regularly conducted systematic reviews of acupuncture for various indications. In fact, the first 6 systematic reviews include my name. This research seems to have created a trend with Korean acupuncture researchers, because ever since they seem unable to stop themselves publishing such articles.

So far so good, a plethora of systematic reviews is not necessarily a bad thing. But looking at the conclusions of these systematic reviews, I seem to notice a worrying trend: while our reviews from the 2008-2010 period arrived at adequately cautious conclusions, the new reviews are distinctly more positive in their conclusions and uncritical in their tone.

Let me explain this by citing the conclusions of the very first (includes me as senior author) and the very last review (does not include me) currently listed in Medline:

1st review

penetrating or non-penetrating sham-controlled RCTs failed to show specific effects of acupuncture for pain control in patients with rheumatoid arthritis. More rigorous research seems to be warranted.

Last review

Electroacupuncture was an effective treatment for MCI [mild cognitive impairment] patients by improving cognitive function. However, the included studies presented a low methodological quality and no adverse effects were reported. Thus, further comprehensive studies with a design in depth are needed to derive significant results.

Now, you might claim that the evidence for acupuncture has overall become more positive over time, and that this phenomenon is the cause for the observed shift. Yet, I don’t see that at all. I very much fear that there is something else going on, something that could be called the suspension of critical thinking.

Whenever I have asked a Chinese researcher why they only publish positive conclusions, the answer was that, in China, it would be most impolite to publish anything that contradicts the views of the researchers’ peers. Therefore, no Chinese researcher would dream of doing it, and consequently, critical thinking is dangerously thin on the ground.

I think that a similar phenomenon might be at the heart of what I observe in the Korean acupuncture literature: while I always tried to make sure that the conclusions were adequately based on the data, the systematic reviews were ok. When my influence disappeared and the reviews were done exclusively by Korean researchers, the pressure of pleasing the Korean peers (and funders) became dominant. I suggest that this is why conclusions now tend to first state that the evidence is positive and subsequently (almost as an after-thought) add that the primary trials were flimsy. The results of this phenomenon could be serious:

  • progress is being stifled,
  • the public is being misled,
  • funds are being wasted,
  • the reputation of science is being tarnished.

Of course, the only right way to express this situation goes something like this:

BECAUSE THE QUALITY OF THE PRIMARY TRIALS IS INADEQUATE, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.

 

 

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