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

risk/benefit

At present, we see a wave of promotion of Traditional Chinese Medicine (TCM) as a treatment of corona-virus infections. In this context, we should perhaps bear in mind that much of the Chinese data seem to be less than reliable. Moreover, I find it important to alert people to a stern warning recently published by two Australian experts. Here is the crucial passage from their paper:

We wish to highlight significant concerns regarding the association between traditional herbal medicines and severe, non-infective interstitial pneumonitis and other aggressive pulmonary syndromes, such as diffuse alveolar haemorrhage and ARDS which have emerged from Chinese and Japanese studies particularly during the period 2017−2019. Initially the association between traditional herbal therapies and pneumonitis was based on isolated case reports. These included hypersensitivity pneumonitis associated with the use of traditional Chinese or Japanese medicines such as Sai-rei-to, Oren-gedoku-to, Seisin-renshi-in and Otsu-ji-to (9 references in supplemental file). Larger cohorts and greater numbers now support this crucial relationship. In a Japanese cohort of 73 patients, pneumonitis development occurred within 3 months of commencing traditional medicine in the majority of patients [], while a large report from the Japanese Ministry of Health, Labor and Welfare, described more than 1000 cases of lung injury secondary to traditional medications, the overwhelming majority of which (852 reports) were described as ‘interstitial lung disease [].

Currently the constituent of traditional herbal medicines which is considered most likely to underlie causation of lung disease is Scutellariae Radix also known as Skullcap or ou-gon, which has been implicated through immunological evidence of hypersensitivity as well as circumstantial evidence, being present in all of those medicines outlined above []. Notably, skullcap is a constituent of QPD as used and described in the paper by Ren et al. relating to COVID-19 []. Scutellariae Radix-induced ARDS and COVID-19 disease share the same characteristic chest CT changes such as ground-glass opacities and airspace consolidation, therefore distinguishing between lung injury due to SARS-CoV-2 and that secondary to TCM may be very challenging. The potential for iatrogenic lung injury with TCM needs to be acknowledged []…

Morbidity and mortality from COVID-19 are almost entirely related to lung pathology []. Factors which impose a burden on lung function such as chronic lung disease and smoking are associated with increased risk for a poor outcome. Severe COVID-19 may be associated with a hypersensitivity pneumonitis component responsive to corticosteroid therapy []. Against this background the use of agents with little or no evidence of clinical efficacy and which have been significantly implicated in causing interstitial pneumonitis that could complicate SARS-CoV-2 infection, should be considered with extreme caution.

In conclusion, the benefits of TCM in the treatment of COVID-19 remain unproven and may be potentially deleterious. We recognise that there is currently insufficient evidence to prove the role of TCM in the causation of interstitial pneumonitis, however the circumstantial data is powerful and it would seem prudent to avoid these therapies in patients with known or suspected SARS-CoV-2 infection, until the evidence supports their use.

Declaration of Competing Interest: There are no conflicts to declare.

Intravenous (IV) vitamin C seems to be recommended more and more, particularly by practitioners of so-called alternative medicine (SCAM). At least this is what this survey suggests:

We surveyed attendees at annual CAM Conferences in 2006 and 2008, and determined sales of intravenous vitamin C by major U.S. manufacturers/distributors. We also queried practitioners for side effects, compiled published cases, and analyzed FDA’s Adverse Events Database. Of 199 survey respondents (out of 550), 172 practitioners administered IV vitamin C to 11,233 patients in 2006 and 8876 patients in 2008. Average dose was 28 grams every 4 days, with 22 total treatments per patient. Estimated yearly doses used (as 25g/50ml vials) were 318,539 in 2006 and 354,647 in 2008. Manufacturers’ yearly sales were 750,000 and 855,000 vials, respectively. Common reasons for treatment included infection, cancer, and fatigue.

Yet, the potential harm associated with the use of IV vitamin C has not been systematically assessed. An international team of researchers aimed to fill this gap by reviewing the available evidence on harm related to such treatment. They included studies in adult populations that reported harm related to IV high-dose vitamin C which they defined as greater than or equal to 6 g/d, greater than or equal to 75 mg/kg/d, or greater than or equal to 3 g/m/d.

They identified 8,149 reports, of which 650 full text were assessed for eligibility, leaving 74 eligible studies. In these studies, 2,801 participants received high-dose vitamin C at a median (interquartile range) dose of 22.5 g/d (8.25-63.75 g/d), 455 mg/kg/d (260-925 mg/kg/d), or 70 g/m/d (50-90 g/m/d); and 932 or more adverse events were reported. Among nine double-blind randomized controlled trials (2,310 patients), adverse events were reported in three studies with an event rate per patient for high-dose vitamin C identical to placebo group in one study (0.1 [1/10] vs 0.1 [1/10]), numerically lower in one study (0.80 [672/839] vs 0.82 [709/869]), and numerically higher in one study (0.33 [24/73] vs 0.23 [17/74]). Six double-blind randomized controlled trials reported no adverse event in either group. Five cases of oxalate nephropathy, five cases of hypernatremia, three cases of hemolysis in glucose-6-phosphate dehydrogenase deficiency patients, two cases of glucometer error, and one case of kidney stones were also reported overall.

The authors concluded that there is no consistent evidence that IV high-dose vitamin C therapy is more harmful than placebo in double-blind randomized controlled trials. However, reports of oxalate nephropathy, hypernatremia, glucometer error, and hemolysis in glucose-6-phosphate dehydrogenase deficiency patients warrant specific monitoring.

So, is IV vitamin C safe or not?

I would interpret these findings as follows:

  • Clinical trials are often very poor yard-sticks for estimating safety; they are too small and often neglect to mention adverse effects.
  • When it come to evaluating the safety of therapeutic interventions, we must therefore often rely on case-reports, case series and other uncontrolled data.
  • Such data show that IV vitamin C has been associated with adverse effects, some of which are serious.
  • The incidence of such event remains unclear.

Steiner with his wife (right) and Ita Wegman, his lover (left).

Anthroposophic medicine was founded by Steiner and Ita Wegman in the early 20th century. Currently, it is being promoted as an extension of conventional medicine. Proponents claim that “its unique understanding of the interplay among physiological, soul and spiritual processes in healing and illness serves to bridge allopathy with naturopathy, homeopathy, functional/nutritional medicine and other healing systems.” Its value has repeatedly been questioned, and clinical research in this area is often less than rigorous.

Anthroposophic education was developed in the Waldorf school that was founded by Steiner in 1919 to serve the children of employees of the Waldorf-Astoria cigarette factory in Stuttgart, Germany. Pupils of Waldorf or Steiner schools, as they are also frequently called, are encouraged to develop independent thinking and creativity, social responsibility, respect, and compassion.

Waldorf schools implicitly infuse spiritual and mystic concepts into their curriculum. Like some other alternative healthcare practitioners – for instance, doctors promoting integrative medicine, chiropractors, homeopaths and naturopaths – some doctors of anthroposophic medicine take a stance against childhood immunizations. In a 2011 paper, I summarised the evidence which showed that in the UK, the Netherlands, Austria and Germany, Waldorf schools have been at the centre of measles outbreaks due to their stance regarding immunisations.

More recently, a study evaluated trends in rates of personal belief exemptions (PBEs) to immunization requirements for private kindergartens in California that practice alternative educational methods. The investigators used California Department of Public Health data on kindergarten PBE rates from 2000 to 2014 to compare annual average increases in PBE rates between schools.

Alternative schools had an average PBE rate of 8.7%, compared with 2.1% among public schools. Waldorf schools had the highest average PBE rate of 45.1%, which was 19 times higher than in public schools (incidence rate ratio = 19.1; 95% confidence interval = 16.4, 22.2). Montessori and holistic schools had the highest average annual increases in PBE rates, slightly higher than Waldorf schools (Montessori: 8.8%; holistic: 7.1%; Waldorf: 3.6%).

The authors concluded that Waldorf schools had exceptionally high average PBE rates, and Montessori and holistic schools had higher annual increases in PBE rates. Children in these schools may be at higher risk for spreading vaccine-preventable diseases if trends are not reversed.

As the world is hoping for the arrival of an effective vaccine against the corona virus, these figures should concern us.

Non-specific chronic neck pain is a common condition. There is hardly a so-called alternative medicine (SCAM) that is not advocated for it. Amongst the most common approaches are manual therapy and therapeutic exercise. But which is more effective?

This study was aimed at answering the question by comparing the effects of manual therapy and therapeutic exercise. The short-term and mid-term effects produced by the two therapies on subjects with non-specific chronic neck pain were studied. The sample was randomized into three groups:

  1. spinal manipulation (n=22),
  2. therapeutic exercise (n=23),
  3. sham treatment (n=20).

The therapists were physiotherapists. Patients were not allowed any other treatments that the ones they were allocated to. Pain quantified by visual analogue scale, the pressure pain threshold, and cervical disability quantified by the Neck Disability Index (NDI) were the outcome measures. They were registered on week 1, week 4, and week 12.

No statistically significant differences were obtained between the experimental groups. Spinal manipulation improved perceived pain quicker than therapeutic exercise. Therapeutic exercise reduced cervical disability quicker than spinal manipulation. Effect size showed medium and large effects for both experimental treatments.

The authors concluded that there are no differences between groups in short and medium terms. Manual therapy achieves a faster reduction in pain perception than therapeutic exercise. Therapeutic exercise reduces disability faster than manual therapy. Clinical improvement could potentially be influenced by central processes.

The paper is poorly written (why do editors accept this?) but it laudably includes detailed descriptions of the three different interventions:

Group 1: Manual therapy

“Manual therapy” protocol was composed of three techniques based on scientific evidence for the treatment of neck pain. This protocol was applied in the three treatment sessions, one per week.

    1. 1.High thoracic manipulation on T4. Patients are positioned supine with their arms crossed in a “V” shape over the chest. The therapist makes contact with the fist at the level of the spinous process of T4 and blocks the patient’s elbows with his chest. Following this, he introduces flexion of the cervical spine until a slight tension is felt in the tissues at the point of contact. Downward and cranial manipulation is applied. If cavitation is not achieved on the first attempt, the therapist repositions the patient and performs a second manipulation. A maximum of two attempts will be allowed in each patient.
    2. 2.Cervical articular mobilization (2 Hz, 2 min × 3 series). The patient is placed on the stretcher in a prone position, placing both hands under his forehead. The therapist makes contact with his two thumbs on the spinous process of the patient’s C2 vertebra and performs grade III posteroanterior impulses at a speed of 2 Hz and for 2 min. There are 3 mobilization intervals with a minute of rest between each one of them [13].
    3. 3.Suboccipital muscle inhibition (3 min). With the patient lying supine, the therapist places both hands under the subject’s head, by contacting their fingers on the lower edge of the occipital bone, and exerts constant and painless pressure in the anterior and cranial direction for 3 min.

Group 2: Therapeutic exercise

“Therapeutic exercise” protocol: this protocol is based on a progression in load composed of different phases: at first, activation and recruitment of deep cervical flexors; secondly, isometric exercise deep and superficial flexors co-contraction, and finally, eccentric recruitment of flexors and extensors. This protocol, as far as we know, has not been studied, but activation of this musculature during similar tasks to those of our protocol has been observed. This protocol was taught to patients in the first session and was performed once a day during the 3 weeks of treatment, 21 sessions in total. It was reinforced by the physiotherapist in each of the three individual sessions.

Week 1: Exercises 1 and 2.

    1. 1.Cranio-cervical flexion (CCF) in a supine position with a towel in the posterior area of the neck (3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest).
    2. 2.CCF sitting (3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest)

Week 2: Exercises 1, 2, 3, and 4.

    1. 3.Co-contraction of deep and superficial neck flexors in supine decubitus (10 repetitions, 10 s of contraction with 10 s of rest).
    2. 4.Co-contraction of flexors, rotators, and lateral flexors. The patients performed cranio-cervical flexion, while the physiotherapist asked him/her to tilt, rotate, and look towards the same side while he/she opposes a resistance with his/her hand (10 repetitions, 10 s of contraction with 10 s of rest).

Week 3: Exercises 1, 2, 3, 4, 5, and 6.

    1. 5.Eccentric for extensors. With the patient seated, he/she should perform cervical extension. Then, he/she must realize a CCF and finish doing a cervical flexion (10 repetitions).
    2. 6.Eccentric for flexors. The patients, placed in a quadrupedal and neutral neck position, should perform neck flexion; then, they must have done a cranio-cervical flexion and, maintaining that posture, extend the neck and then finally lose the CCF (10 repetitions).

Group 3: Sham treatment

For the “control” protocol, the patients were placed in the supine position, while the physiotherapist placed his hands without therapeutic intention on the patient’s neck for 3 min. The physiotherapist simulated the technique of suboccipital inhibition. Later, with the laser pointer off, patients were contacted without exerting pressure for 10 s. Patients assigned to the control group received treatment 1 or 2 after completing the study.

This study has many strengths and several weaknesses (for instance the small sample sizes). Its results are not surprising. They confirm what I have been pointing out repeatedly, namely that, because exercise is cheaper and has less potential for harm, it is by far a better treatment for chronic neck pain than spinal manipulation.

Breast cancer and its treatments lead to a decrease in patients’ quality of life (QOL). This systematic review aimed to assess the effectiveness of so-called alternative medicine (SCAM) on the QOL of women with breast cancer.

A total of 28 clinical trials were included in the systematic review, 18 of which were randomized controlled trials (RCTs). Participants included women with breast cancer who were undergoing the first three phases of breast cancer or post-cancer rehabilitation. One study tested a dietary supplement, and the other 27 tested a variety of mind-body techniques (the authors counted the following modalities in this category: acupuncture, hyperthermia, movement therapy (qigong), laser therapy, orthomolecular therapy, osteopathy, phototherapy, healing touch, homeopathy, lymphatic drainage, magnet field therapy, manual therapy, neural therapy, Shiatsu). Twenty-seven studies showed improved QOL.

The authors concluded that the findings may indicate the potential benefits of SCAMs, especially mind-body techniques on QOL in breast cancer patients. Further RCTs or long-term follow-up studies are recommended. Moreover, the use of similar QOL assessment tools allows for more meta-analysis and generalizability of results, especially for the development of clinical guidelines.

This is a somewhat odd paper:

  • it is poorly written,
  • it lumps together SCAMs that do not belong in the same category,
  • it only considered studies published in English,
  • it included studies regardless of study design, even those without any control groups.

Regardless of these consideration, it stands to reason that patients’ QoL can be improved by SCAM. Only a fool would deny that a bit of extra care, kindness, attention and time is good for patients. The relevant questions, however, are quite different:

  1. Is this effect due to the extra attention and care or is it due to specific effects of SCAM?
  2. Which SCAM is best at achieving an improvement of QoL?
  3. Are the truly effective SCAMs better than conventional interventions aimed at improving QoL?

These are by no means academic questions but issues that need to be addressed to improve cancer care, and tackling them is in the best interest of suffering patients. Sadly, none of them can be answered by conducting poor quality systematic reviews of the evidence. Even more sadly, few of the proponents of integrated medicine want to face the music and answer these questions. They seem to prefer to stand in the way of progress, to ignore medical ethics, to blindly and naively integrate any old nonsense from the realm of SCAM (anything from homeopathy to Reiki) into routine care without probing further and without wanting to know the facts.

It is almost as though they are afraid of the truth.

Spinal manipulative therapy (SMT) is frequently used to manage cervicogenic headache (CGHA). No meta-analysis has investigated the effectiveness of SMT exclusively for CGHA.

The aim of this review was to evaluate the effectiveness of SMT for cervicogenic headache (CGHA). Seven RCTs were eligible. At short-term follow-up, there was a significant, small effect favouring SMT for pain intensity and small effects for pain frequency. There was no effect for pain duration. There was a significant, small effect favouring SMT for disability. At intermediate follow-up, there was no significant effects for pain intensity and a significant, small effect favouring SMT for pain frequency. At long-term follow-up, there was no significant effects for pain intensity and for pain frequency.

The authors concluded that for CGHA, SMT provides small, superior short-term benefits for pain intensity, frequency and disability but not pain duration, however, high-quality evidence in this field is lacking. The long-term impact is not significant.

This meta-analysis can be criticised for a long list of reasons, the most serious of which, in my view, is that it is bar of even the tiniest critical input. The authors state that there has been no previous meta-analysis on this topic. This might be true, but there has been a systematic review of it (published in the leading journal on the subject) which the authors fail to mention/cite (I wonder why!). It is from 2011 and happens to be one of mine. Here is its abstract:

The objective of this systematic review was to assess the effectiveness of spinal manipulations as a treatment option for cervicogenic headaches. Seven databases were searched from their inception to February 2011. All randomized trials which investigated spinal manipulations performed by any type of healthcare professional for treating cervicogenic headaches in human subjects were considered. The selection of studies, data extraction, and validation were performed independently by 2 reviewers. Nine randomized clinical trials (RCTs) met the inclusion criteria. Their methodological quality was mostly poor. Six RCTs suggested that spinal manipulation is more effective than physical therapy, gentle massage, drug therapy, or no intervention. Three RCTs showed no differences in pain, duration, and frequency of headaches compared to placebo, manipulation, physical therapy, massage, or wait list controls. Adequate control for placebo effect was achieved in 1 RCT only, and this trial showed no benefit of spinal manipulations beyond a placebo effect. The majority of RCTs failed to provide details of adverse effects. There are few rigorous RCTs testing the effectiveness of spinal manipulations for treating cervicogenic headaches. The results are mixed and the only trial accounting for placebo effects fails to be positive. Therefore, the therapeutic value of this approach remains uncertain.

The key points here are:

  • methodological quality of the primary studies was mostly poor;
  • adequate control for placebo effect was achieved in 1 RCT only;
  • this trial showed no benefit of SMT beyond a placebo effect;
  • the majority of RCTs failed to provide details of adverse effects;
  • this means they violate research ethics and should be discarded as not trustworthy;
  • the therapeutic value of SMT remains uncertain.

The new paper was published by chiropractors. Its positive result is not clinically relevant, almost certainly due to residual bias and confounding in the primary studies, and thus most likely false-positive. The conclusions seem to disclose more the bias of the review authors than the truth. Considering the risks of SMT of the upper spine (a subject not even mentioned by the authors), I cannot see that the risk/benefit balance of this treatment is positive. It follows, I think, that other, less risky and more effective treatments are to be preferred for CGHA.

In 2012, we evaluated the efficacy/effectiveness of lavender for the reduction of stress/anxiety.

Our systematic review included 15 RCTs. Two trials scored 4 points on the 5-point Jadad scale, the remaining 13 scored two or less. Results from seven trials appeared to favour lavender over controls for at least one relevant outcome. We concluded that methodological issues limit the extent to which any conclusions can be drawn regarding the efficacy/effectiveness of lavender. The best evidence suggests that oral lavender supplements may have some therapeutic effects. However, further independent replications are needed before firm conclusions can be drawn.

Since 2012, more evidence has emerged. The latest study on the subject aimed to investigate the effects of lavender oil on sleep and quality of life of menopausal women through steam inhalation. It was quasi-experimental with pre-test/post-test placebo control groups. It was conducted with 57 women, 27 of whom were subject to aromatherapy and 30 to a placebo. Data were collected using the Questionnaire Form, the Pittsburgh Sleep Quality Index (PSQI) and the Menopause-Specific Quality of Life Questionnaire (MENQOL).

For the intervention group, the PSQI median scores after the administration of aromatherapy were found to be significantly lower than those before the administration (p < 0.001) and those of the placebo group (p < 0.001). Similarly, for the intervention group, the total median MENQOL scores after the administration of the aromatherapy were found to be significantly lower than the scores prior to the administration (p < 0.001) as well as the scores of the placebo group (p < 0.001). See the source image

The authors of the new study concluded that that aromatherapy involving lavender-scented steam inhalation increased sleep quality and quality of life in women with sleep deprivation problems during menopause.

Hurray, this seems to be a decent trial with a positive result for SCAM!

And why not? It is not at all implausible that lavender has hypnotic effects. There are now quite a few reasonably sound trials that suggest it works. Moreover, it is safe and not very expensive (or even free, if you can grow it yourself).

I for one am more than happy to report a positive finding for a SCAM and merely regret that I cannot do so more often.

The objective of this study was to identify adverse drug reactions (ADR) associated with the use of so-called alternative medicine (SCAM) in Malaysia and to define factors which are associated with the more serious reactions. For this purpose, all ADR associated with the use of SCAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.

From a total of 74 997 reports in the database, 930 (1.2%) involved SCAM products. From a total of 930 reports, 242 (26%) were serious ADR with 36 deaths. Six people died as a result of taking the SCAM, while another 30 cases were possibly associated with the SCAM products. Among the 36 mortality cases, adulterants were detected in 30% of cases. Examples of adulterants were dexamethasone, avanafil, nortadalafil and banned drugs such as phenylbutazone and sibutramine

About a third of the reports involved used SCAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the SCAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).

The authors concluded that the prevalence of serious ADR associated with SCAM products is high. Factors identified with serious ADR included ethnicity, SCAM users with pre-existing diseases, use of SCAM for chronic illnesses and concomitant use of SCAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of SCAM products.

The authors also point out that underreporting of ADRs remains a major ongoing issue in pharmacovigilance. Many SCAM consumers may not be vigilant or may be unaware of ADR they experience due to misconceptions on the
safety of SCAM products. Most doctors rarely ask their patients about the use of SCAM.

To this, I would add that SCAM providers do their utmost to give the impression that their products are natural and therefore safe. Furthermore the press is far too often perpetuating the myth, and the regulators tend to turn a blind eye.

I expect that some readers of this post will now point out that the rate of SCAM-related ADRs is very small compared to that of conventional drugs. They would be correct, of course. But they would also miss the point that the value of a treatment is not determined by its risk alone. It is determined by the risk/benefit balance. Where there is no effectiveness, this balance is negative, even if the risk is tiny.

So, now let me challenge the defenders of SCAM to name a few SCAMs that are demonstrably associated with a positive risk/benefit balance.

 

By guest blogger Loretta Marron

Although assumed to be traditional, what we know today as ‘Traditional Chinese Medicine’ (TCM) was invented in the 1950s for political reasons by then Chairman Mao. It has since been proclaimed by Xi Jinping, now life-President of the People’s Republic of China, as the “jewel” in the millennia of Chinese civilization.

In May this year, Xi “announced plans to criminalise criticism of traditional Chinese medicine”. Speaking out against TCM could land you years in prison, prosecuted for “picking fights to disturb public order” and “defaming” the practice.

With the industry expected to earn $420 billion by the end of 2020, covid-19 has provided Xi with a platform to promote unproven, potentially harmful TCM. To keep these profits filling Chinese coffers, the World Health Organization (WHO) remains silent and those challenging TCM are silenced.

In January, the late Dr Li Wenliang was arrested and gaoled for warning China about covid-19. Li was one of up to nine people who were disciplined for spreading rumours about it. As the virus silently spread around the world, Beijing told the WHO that there was ‘no clear evidence’ of spread between humans.

As their death toll passed 1,000, Beijing’s response was to remove senior officials and to sack hundreds over their handling of the outbreak. With the support of the WHO, claims continue to be made that TCM “has been proved effective in improving the cure rate”, denying the simple fact that “patients would have recovered even if they hadn’t taken the Chinese medicine”.

With cases now heading for 8 million, and over four hundred thousand people confirmed dead world-wide and with economies in free-fall, Beijing continues, “to protect its interests and people overseas; to gain leadership of international governance”,for financial gain, to aggressively use its national power. Under the guise of ‘International Aid’, during the pandemic, Beijing promoted treatments based on unproven traditional medicine, sending TCM practitioners to countries including Italy, France and Iran.

Countries challenging Beijing can expect claims of racism and financial retaliation.

Back in 2016, the Chinese State Council released a “Strategic Development Plan for Chinese Medicine (2016-2030)”, seeking to spread ‘knowledge’ into campuses, homes and abroad.

In July 2017, a law promising equal status for TCM and western medicine came into effect. Provisions included encouragement to China’s hospitals to set up TCM centres. “The new law on traditional Chinese medicine will improve global TCM influence, and give a boost to China’s soft power”.

In 2019, after strong lobbying by the Chinese Communist Party (CCP), WHO added a chapter on TCM to their official International Classification of Diseases (ICD-11).  In China, doctors are now instructed to prescribe traditional medicine to most patients.

While Chinese herbs might have exotic names, they are, once translated, often the same as western herbs, many of which might have significant interactions. WHO fails to acknowledge any drug interactions.

In 1967, Mao launched Project 523 to find a cure for chloroquine-resistant malaria. Over 240,000 compounds had already been tested and none had worked. Trained in pharmacology and modern western methods, Tu Youyou used the scientific method to test sweet wormwood, a herb traditionally used in China for fever, where she developed a useful artemisinin derivative for resistant malaria. The drug has saved millions of lives. In 2015 she won the Nobel Prize for her work. However, Tu’s work is not a blanket endorsement of TCM: without the years of research, she would not have been successful.

TCM is commercially driven. Criticism of remedies is often blocked on the Internet in China, and critics have been jailed.  The majority of TCM’s are not tested for efficacy in randomized clinical trials. Clinical trials are usually of poor quality and serious side effects are underreported.   China has even rolled back regulations as Beijing forcefully promotes TCM’s as an alternative to proven western medicine. An increasing number of prestigious research hospitals now prescribe and dispense herbs that may cause drug interactions alongside western medicine for major illness patients.

TCM’s are not safe. Most systematic reviews suggest that there is no good or consistent evidence for effectiveness, negative results aren’t published, research data are fabricated and TCM-exports are of dubious quality.

If the benefits of herbal remedies are to be realised, good clinical studies must be encouraged.

TCM is not medicine. It’s little more than a philosophy or a set of traditional beliefs, about various concoctions and interventions and their alleged effect on health and diseases.

To stop misleading the world with what Mao himself saw as nonsense, and to mitigate future pandemics, WHO can and should remove all mention of TCM other than to state that it is unproven and could be dangerous.

Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

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