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

acupuncture

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One theory as to how acupuncture works is that it increases endorphin levels in the brain. These ‘feel-good’ chemicals could theoretically be helpful for weaning alcohol-dependent people off alcohol. So, for once, we might have a (semi-) plausible mechanism as to how acupuncture could be clinically effective. But a ‘beautiful hypothesis’ does not necessarily mean acupuncture works for alcohol dependence. To answer this question, we need clinical trials or systematic reviews of clinical trials.

A new systematic review assessed the effects and safety of acupuncture for alcohol withdrawal syndrome (AWS). All RCTs of drug plus acupuncture or acupuncture alone for the treatment of AWS were included. Eleven RCTs with a total of 875 participants were included. In the acute phase, two trials reported no difference between drug plus acupuncture and drug plus sham acupuncture in the reduction of craving for alcohol; however, two positive trials reported that drug plus acupuncture was superior to drug alone in the alleviation of psychological symptoms. In the protracted phase, one trial reported acupuncture was superior to sham acupuncture in reducing the craving for alcohol, one trial reported no difference between acupuncture and drug (disulfiram), and one trial reported acupuncture was superior to sham acupuncture for the alleviation of psychological symptoms. Adverse effects were tolerable and not severe.

The authors concluded that there was no significant difference between acupuncture (plus drug) and sham acupuncture (plus drug) with respect to the primary outcome measure of craving for alcohol among participants with AWS, and no difference in completion rates (pooled results). There was limited evidence from individual trials that acupuncture may reduce alcohol craving in the protracted phase and help alleviate psychological symptoms; however, given concerns about the quantity and quality of included studies, further large-scale and well-conducted RCTs are needed.

There is little to add here. Perhaps just two short points:

1. The quality of the trials was poor; only one study of the 11 trials was of acceptable rigor. Here is its abstract:

We report clinical data on the efficacy of acupuncture for alcohol dependence. 503 patients whose primary substance of abuse was alcohol participated in this randomized, single blind, placebo controlled trial. Patients were assigned to either specific acupuncture, nonspecific acupuncture, symptom based acupuncture or convention treatment alone. Alcohol use was assessed, along with depression, anxiety, functional status, and preference for therapy. This article will focus on results pertaining to alcohol use. Significant improvement was shown on nearly all measures. There were few differences associated with treatment assignment and there were no treatment differences on alcohol use measures, although 49% of subjects reported acupuncture reduced their desire for alcohol. The placebo and preference for treatment measures did not materially effect the results. Generally, acupuncture was not found to make a significant contribution over and above that achieved by conventional treatment alone in reduction of alcohol use.

To me, this does not sound all that encouraging.

2.  Of the 11 RCTs, 8 failed to report on adverse effects of acupuncture. In my book, this means these trials were in violation with basic research ethics.

My conclusion of all this: another ugly fact kills a beautiful hypothesis.

Acupuncture research does not have a good name; if it originates from China, even less so.

And this note in ‘ACUPUNCTURE IN MEDICINE’ is not likely to change this image:

Fang J, Keller CL, Chen L, et al. Effect of acupuncture and Chinese herbal medicine on subacute stroke outcomes: a single-centre randomised controlled trial. Acupuncture in Medicine Published online first 10 November 2017. doi: 10.1136/acupmed-2016-011167.

This article is retracted by the Editor-in-Chief on grounds of redundant publication.

The above article reports that a trial originally planned to be carried out at three hospitals was reduced to a single centre for reasons of cost. This is incorrect. The full three-centre trial was run and reported elsewhere (Scientific Reports 6, Article number: 25850 (2016) DOI: 10.1038/srep25850).

The Scientific Reports paper was accepted for publication prior to submission of the above paper to Acupuncture in Medicine. The third author takes responsibility for the mistake. All authors have agreed to this retraction.

The abstract of the paper in SCIENTIFIC REPORTS is here:

To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation.

I find all this odd in several ways:

  • The publication of the ACUPUNCTURE IN MEDICINE article does not seem to have been a ‘mistake‘ but plain scientific fraud, in my view.
  • The paper in SCIENTIFIC REPORTS (SR) was published in May 2016. Therefore the reviewers and editor of AIM could and should have spotted the fraud.
  • In the SR paper, the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. As the authors were affiliated to three different departments of acupuncture, I feel this to be debatable.

What do you think?

Bee venom acupuncture is a form of acupuncture in which bee venom is applied to the tips of acupuncture needles, stingers are extracted from bees, or bees are held with an instrument exposing the stinger, and applied to acupoints on the skin.

Bee venom consisting of multiple anti-inflammatory compounds such as melittin, adolapin, apamin. Other substances such as phospholipase A2 can be anti-inflammatory in low concentrations and pro-inflammatory in others. However, bee venom also contains proinflammatory substances, melittin, mast cell degranulation peptide 401, and histamine.

Bee venom acupuncture has been used to treat a number of conditions such as lumbar disc disease, osteoarthritis of the knee, rheumatoid arthritis, adhesive capsulitis, lateral epicondylitis, peripheral neuropathies, stroke and Parkinson’s Disease. The quality of these studies tends to be so poor that any verdict on the effectiveness of bee venom acupuncture would be premature.

A new clinical trial of bee-venom acupuncture for rheumatoid arthritis (RA) might change this situation. A total of 120 cases of RA patients were randomized into bee-sting acupuncture group (treatment) and western medicine group (control). The patients of the control group were treated by oral administration of Methotrexate (10 mg, once a week) and Celecoxlb (0.2 g, once a day). Those of the treatment group received 5 to 15 bee stings of Ashi-points or acupoints according to different conditions and corporeity, and with the bee-sting retained for about 5 min every time, once every other day. The treatment lasted for 8 weeks. The therapeutic effect was assessed by examining:

  • symptoms and signs of the affected joints as morning stiffness duration,
  • swollen/tender joint counts (indexes),
  • handgrip strength,
  • 15 m-walking time,
  • visual analogue scale (VAS),
  • Disease Activity Score including a 28-joint count (DAS 28),
  • rheumatoid factor (RF),
  • erythrocyte sedimentation rate (ESR),
  • C-reactive protein (CRP),
  • anti-cyclic citrullinated peptide antibody (ACCPA).

For assessing the safety of bee-venom acupuncture, the patients’ responses of fever, enlargement of lymph nodes, regional red and swollen, itching, blood and urine tests for routine were examined.

Findings of DAS 28 responses displayed that of the two 60 cases in the control and bee-venom acupuncture groups, 15 and 18 experienced marked improvement, 33 and 32 were effective, 12 and 10 ineffective, with the effective rates being 80% and 83. 33%, respectively. No significant difference was found between the two groups in the effective rate (P>0.05). After the treatment, both groups have witnessed a marked decrease in the levels of morning stiffness duration, arthralgia index, swollen joint count index, joint tenderness index, 15 m walking time, VAS, RF, ESR, CRP and ACCPA, and an obvious increase of handgrip strength relevant to their own levels of pre-treatment in each group (P<0.05). There were no significant differences between the two groups in the abovementioned indexes (P>0.05). The routine blood test, routine urine test, routine stool test, electrocardiogram result, the function of liver and kidney and other security index were within the normal range, without any significant adverse effects found after bee-stinging treatment.

The authors (from the Department of Acupuncture and Moxibustion, Bao’an Hospital of Traditional Chinese Medicine, Shenzhen, China) concluded that bee-venom acupuncture therapy for RA patients is safe and effective, worthy of popularization and application in clinical practice.

Where to start? There is so much – perhaps I just comment on the conclusion:

  • Safety cannot be assessed on the basis of such a small sample. Bee venom can cause anaphylaxis, and several deaths have been reported in patients who successfully received the therapy prior to the adverse event. Because there is no adverse-effect monitoring system, the incidence of adverse events is unknown. Stating that it is safe, is therefore a big mistake.
  • The trial was a non-superiority study. As such, it needs a much larger sample to be able to make claims about effectiveness.
  • From the above two points, it follows that popularization and application in clinical practice would be a stupid exercise.

So, what is left over from this seemingly rigorous RCT?

NOTHING!

(except perhaps a re-affirmation of my often-voiced fear that we must take TCM-studies from China with more than just one pinch of salt)

Traditional Chinese Medicine (TCM) is the umbrella term for modalities historically used in ancient China. TCM includes many therapeutic and some diagnostic modalities. Even though, these modalities differ in many respects, they are claimed to have in common that they are based on assumptions most of which originate from Taoist philosophy:

  • The human body is a miniature version of the universe.
  • Harmony between the two opposing forces, yin and yang, means health.
  • Disease is caused by an imbalance between these forces.
  • Five elements—fire, earth, wood, metal, and water—symbolically represent all phenomena, including the stages of human life, and explain the functioning of the body and how it changes during disease.
  • The vital energy, qi or chi, flows through the body in meridians, is essential for maintaining health.

TCM is a construct of Mao Zedong who lumped all historical Chinese treatments together under this umbrella and created the ‘barefoot doctor’ to practice TCM nationwide – not because he believed in TCM, but because China was desperately short of real doctors and needed at least a semblance of healthcare.

Over the past few years, China has been aggressively promoting TCM for expanding its global influence and for a share of the estimated US$50-billion global market (of products of dubious quality). A recent article in ‘Nature’ explains that the WHO’s governing body, the World Health Assembly, is set to adopt the 11th version of the organization’s global compendium — known as the International Statistical Classification of Diseases and Related Health Problems (ICD). For the first time, the ICD will include information about TCM. Chapter 26 of the ICD will feature a classification system on TCM, largely based not on science or facts, but on obsolete nonsense.

The WHO’s support applies to all traditional medicines, but its relationship with Chinese medicine, and with China, has grown especially close, in particular during the tenure of Margaret Chan, who ran the organization from 2006 to 2017 and made sure that several documents favourable to TCM were passed. The WHO’s declarations about traditional medicine are puzzling. Various of these WHO documents call for the integration of “traditional medicine, of proven quality, safety and efficacy”, while being silent as to which traditional medicines and diagnostics are proven. Wu Linlin, a WHO representative in the Beijing office, told Nature that the “WHO does not endorse particular traditional and complementary medicine procedures or remedies”.

But this is evidently not the case and in sharp contrast to the WHO’s actions in other areas. The agency provides, for instance, specific advice on what vaccines and drugs to use and what foods to avoid. With traditional medicines, however, such specifics are missing. The message therefore can only be that the WHO endorses TCM as safe and effective.

The evidence, however, tells us a different story. On this blog, we have repeatedly discussed that:

China’s drug regulator gets more than 230,000 reports of adverse effects from TCM each year, and Chinese herbal medicines carry multiple direct risks:

To this, we have to add the indirect risk of employing useless treatments for otherwise treatable conditions.

In view of all this, the WHO’s endorsement of TCM and its obsolete concepts is not just not understandable, it is a dangerous step backwards and, in my view, even intolerable.

I remember reading this paper entitled ‘Comparison of acupuncture and other drugs for chronic constipation: A network meta-analysis’ when it first came out. I considered discussing it on my blog, but then decided against it for a range of reasons which I shall explain below. The abstract of the original meta-analysis is copied below:

The objective of this study was to compare the efficacy and side effects of acupuncture, sham acupuncture and drugs in the treatment of chronic constipation. Randomized controlled trials (RCTs) assessing the effects of acupuncture and drugs for chronic constipation were comprehensively retrieved from electronic databases (such as PubMed, Cochrane Library, Embase, CNKI, Wanfang Database, VIP Database and CBM) up to December 2017. Additional references were obtained from review articles. With quality evaluations and data extraction, a network meta-analysis (NMA) was performed using a random-effects model under a frequentist framework. A total of 40 studies (n = 11032) were included: 39 were high-quality studies and 1 was a low-quality study. NMA showed that (1) acupuncture improved the symptoms of chronic constipation more effectively than drugs; (2) the ranking of treatments in terms of efficacy in diarrhoea-predominant irritable bowel syndrome was acupuncture, polyethylene glycol, lactulose, linaclotide, lubiprostone, bisacodyl, prucalopride, sham acupuncture, tegaserod, and placebo; (3) the ranking of side effects were as follows: lactulose, lubiprostone, bisacodyl, polyethylene glycol, prucalopride, linaclotide, placebo and tegaserod; and (4) the most commonly used acupuncture point for chronic constipation was ST25. Acupuncture is more effective than drugs in improving chronic constipation and has the least side effects. In the future, large-scale randomized controlled trials are needed to prove this. Sham acupuncture may have curative effects that are greater than the placebo effect. In the future, it is necessary to perform high-quality studies to support this finding. Polyethylene glycol also has acceptable curative effects with fewer side effects than other drugs.

END OF 1st QUOTE

This meta-analysis has now been retracted. Here is what the journal editors have to say about the retraction:

After publication of this article [1], concerns were raised about the scientific validity of the meta-analysis and whether it provided a rigorous and accurate assessment of published clinical studies on the efficacy of acupuncture or drug-based interventions for improving chronic constipation. The PLOS ONE Editors re-assessed the article in collaboration with a member of our Editorial Board and noted several concerns including the following:

  • Acupuncture and related terms are not mentioned in the literature search terms, there are no listed inclusion or exclusion criteria related to acupuncture, and the outcome measures were not clearly defined in terms of reproducible clinical measures.
  • The study included acupuncture and electroacupuncture studies, though this was not clearly discussed or reported in the Title, Methods, or Results.
  • In the “Routine paired meta-analysis” section, both acupuncture and sham acupuncture groups were reported as showing improvement in symptoms compared with placebo. This finding and its implications for the conclusions of the article were not discussed clearly.
  • Several included studies did not meet the reported inclusion criteria requiring that studies use adult participants and assess treatments of >2 weeks in duration.
  • Data extraction errors were identified by comparing the dataset used in the meta-analysis (S1 Table) with details reported in the original research articles. Errors included aspects of the study design such as the experimental groups included in the study, the number of study arms in the trial, number of participants, and treatment duration. There are also several errors in the Reference list.
  • With regard to side effects, 22 out of 40 studies were noted as having reported side effects. It was not made clear whether side effects were assessed as outcome measures for the other 18 studies, i.e. did the authors collect data clarifying that there were no side effects or was this outcome measure not assessed or reported in the original article. Without this clarification the conclusion comparing side effect frequencies is not well supported.
  • The network geometry presented in Fig 5 is not correct and misrepresents some of the study designs, for example showing two-arm studies as three-arm studies.
  • The overall results of the meta-analysis are strongly reliant on the evidence comparing acupuncture versus lactulose treatment. Several of the trials that assessed this comparison were poorly reported, and the meta-analysis dataset pertaining to these trials contained data extraction errors. Furthermore, potential bias in studies assessing lactulose efficacy in acupuncture trials versus lactulose efficacy in other trials was not sufficiently addressed.

While some of the above issues could be addressed with additional clarifications and corrections to the text, the concerns about study inclusion, the accuracy with which the primary studies’ research designs and data were represented in the meta-analysis, and the reporting quality of included studies directly impact the validity and accuracy of the dataset underlying the meta-analysis. As a consequence, we consider that the overall conclusions of the study are not reliable. In light of these issues, the PLOS ONE Editors retract the article. We apologize that these issues were not adequately addressed during pre-publication peer review.

LZ disagreed with the retraction. YM and XD did not respond.

END OF 2nd QUOTE

Let me start by explaining why I initially decided not to discuss this paper on my blog. Already the first sentence of the abstract put me off, and an entire chorus of alarm-bells started ringing once I read further.

  • A meta-analysis is not a ‘study’ in my book, and I am somewhat weary of researchers who employ odd or unprecise language.
  • We all know (and I have discussed it repeatedly) that studies of acupuncture frequently fail to report adverse effects (in doing this, their authors violate research ethics!). So, how can it be a credible aim of a meta-analysis to compare side-effects in the absence of adequate reporting?
  • The methodology of a network meta-analysis is complex and I know not a lot about it.
  • Several things seemed ‘too good to be true’, for instance, the funnel-plot and the overall finding that acupuncture is the best of all therapeutic options.
  • Looking at the references, I quickly confirmed my suspicion that most of the primary studies were in Chinese.

In retrospect, I am glad I did not tackle the task of criticising this paper; I would probably have made not nearly such a good job of it as PLOS ONE eventually did. But it was only after someone raised concerns that the paper was re-reviewed and all the defects outlined above came to light.

While some of my concerns listed above may have been trivial, my last point is the one that troubles me a lot. As it also related to dozens of Cochrane reviews which currently come out of China, it is worth our attention, I think. The problem, as I see it, is as follows:

  • Chinese (acupuncture, TCM and perhaps also other) trials are almost invariably reporting positive findings, as we have discussed ad nauseam on this blog.
  • Data fabrication seems to be rife in China.
  • This means that there is good reason to be suspicious of such trials.
  • Many of the reviews that currently flood the literature are based predominantly on primary studies published in Chinese.
  • Unless one is able to read Chinese, there is no way of evaluating these papers.
  • Therefore reviewers of journal submissions tend to rely on what the Chinese review authors write about the primary studies.
  • As data fabrication seems to be rife in China, this trust might often not be justified.
  • At the same time, Chinese researchers are VERY keen to publish in top Western journals (this is considered a great boost to their career).
  • The consequence of all this is that reviews of this nature might be misleading, even if they are published in top journals.

I have been struggling with this problem for many years and have tried my best to alert people to it. However, it does not seem that my efforts had even the slightest success. The stream of such reviews has only increased and is now a true worry (at least for me). My suspicion – and I stress that it is merely that – is that, if one would rigorously re-evaluate these reviews, their majority would need to be retracted just as the above paper. That would mean that hundreds of papers would disappear because they are misleading, a thought that should give everyone interested in reliable evidence sleepless nights!

So, what can be done?

Personally, I now distrust all of these papers, but I admit, that is not a good, constructive solution. It would be better if Journal editors (including, of course, those at the Cochrane Collaboration) would allocate such submissions to reviewers who:

  • are demonstrably able to conduct a CRITICAL analysis of the paper in question,
  • can read Chinese,
  • have no conflicts of interest.

In the case of an acupuncture review, this would narrow it down to perhaps just a handful of experts worldwide. This probably means that my suggestion is simply not feasible.

But what other choice do we have?

One could oblige the authors of all submissions to include full and authorised English translations of non-English articles. I think this might work, but it is, of course, tedious and expensive. In view of the size of the problem (I estimate that there must be around 1 000 reviews out there to which the problem applies), I do not see a better solution.

(I would truly be thankful, if someone had a better one and would tell us)

Psoriasis is one of those conditions that is

  • chronic,
  • not curable,
  • irritating to the point where it reduces quality of life.

In other words, it is a disease for which virtually all alternative treatments on the planet are claimed to be effective. But which therapies do demonstrably alleviate the symptoms?

This review (published in JAMA Dermatology) compiled the evidence on the efficacy of the most studied complementary and alternative medicine (CAM) modalities for treatment of patients with plaque psoriasis and discusses those therapies with the most robust available evidence.

PubMed, Embase, and ClinicalTrials.gov searches (1950-2017) were used to identify all documented CAM psoriasis interventions in the literature. The criteria were further refined to focus on those treatments identified in the first step that had the highest level of evidence for plaque psoriasis with more than one randomized clinical trial (RCT) supporting their use. This excluded therapies lacking RCT data or showing consistent inefficacy.

A total of 457 articles were found, of which 107 articles were retrieved for closer examination. Of those articles, 54 were excluded because the CAM therapy did not have more than 1 RCT on the subject or showed consistent lack of efficacy. An additional 7 articles were found using references of the included studies, resulting in a total of 44 RCTs (17 double-blind, 13 single-blind, and 14 nonblind), 10 uncontrolled trials, 2 open-label nonrandomized controlled trials, 1 prospective controlled trial, and 3 meta-analyses.

Compared with placebo, application of topical indigo naturalis, studied in 5 RCTs with 215 participants, showed significant improvements in the treatment of psoriasis. Treatment with curcumin, examined in 3 RCTs (with a total of 118 participants), 1 nonrandomized controlled study, and 1 uncontrolled study, conferred statistically and clinically significant improvements in psoriasis plaques. Fish oil treatment was evaluated in 20 studies (12 RCTs, 1 open-label nonrandomized controlled trial, and 7 uncontrolled studies); most of the RCTs showed no significant improvement in psoriasis, whereas most of the uncontrolled studies showed benefit when fish oil was used daily. Meditation and guided imagery therapies were studied in 3 single-blind RCTs (with a total of 112 patients) and showed modest efficacy in treatment of psoriasis. One meta-analysis of 13 RCTs examined the association of acupuncture with improvement in psoriasis and showed significant improvement with acupuncture compared with placebo.

The authors concluded that CAM therapies with the most robust evidence of efficacy for treatment of psoriasis are indigo naturalis, curcumin, dietary modification, fish oil, meditation, and acupuncture. This review will aid practitioners in advising patients seeking unconventional approaches for treatment of psoriasis.

I am sorry to say so, but this review smells fishy! And not just because of the fish oil. But the fish oil data are a good case in point: the authors found 12 RCTs of fish oil. These details are provided by the review authors in relation to oral fish oil trials: Two double-blind RCTs (one of which evaluated EPA, 1.8g, and DHA, 1.2g, consumed daily for 12 weeks, and the other evaluated EPA, 3.6g, and DHA, 2.4g, consumed daily for 15 weeks) found evidence supporting the use of oral fish oil. One open-label RCT and 1 open-label non-randomized controlled trial also showed statistically significant benefit. Seven other RCTs found lack of efficacy for daily EPA (216mgto5.4g)or DHA (132mgto3.6g) treatment. The remainder of the data supporting efficacy of oral fish oil treatment were based on uncontrolled trials, of which 6 of the 7 studies found significant benefit of oral fish oil. This seems to support their conclusion. However, the authors also state that fish oil was not shown to be effective at several examined doses and duration. Confused? Yes, me too!

Even more confusing is their failure to mention a single trial of Mahonia aquifolium. A 2013 meta-analysis published in the British Journal of Dermatology included 5 RCTs of Mahonia aquifolium which, according to these authors, provided ‘limited support’ for its effectivenessHow could they miss that?

More importantly, how could the reviewers miss to conduct a proper evaluation of the quality of the studies they included in their review (even in their abstract, they twice speak of ‘robust evidence’ – but how can they without assessing its robustness? [quantity is not remotely the same as quality!!!]). Without a transparent evaluation of the rigour of the primary studies, any review is nearly worthless.

Take the 12 acupuncture trials, for instance, which the review authors included based not on an assessment of the studies but on a dodgy review published in a dodgy journal. Had they critically assessed the quality of the primary studies, they could have not stated that CAM therapies with the most robust evidence of efficacy for treatment of psoriasis …[include]… acupuncture. Instead they would have had to admit that these studies are too dubious for any firm conclusion. Had they even bothered to read them, they would have found that many are in Chinese (which would have meant they had to be excluded in their review [as many pseudo-systematic reviewers, the authors only considered English papers]).

There might be a lesson in all this – well, actually I can think of at least two:

  1. Systematic reviews might well be the ‘Rolls Royce’ of clinical evidence. But even a Rolls Royce needs to be assembled correctly, otherwise it is just a heap of useless material.
  2. Even top journals do occasionally publish poor-quality and thus misleading reviews.

By guest blogger Hans-Werner Bertelsen

Holistic ideas are booming, and they do not stop at dental medicine, where procedures and techniques that take an alleged ‘holistic’ approach are becoming more and more popular. Are these procedures and techniques effective, and do they offer a benefit over their conventional counterparts, or is it rather the providers of such procedures and techniques who benefit from a lack of knowledge and understanding in patients who seek out this so-called alternative dentistry? This paper will take a look at three topics—the concept of projections, material testing approaches, amalgam removal—that form the basis for many procedures and techniques in so-called alternative dentistry, to examine whether they offer a sound foundation for said procedures and techniques, or whether they are merely empty promises. Might they be nothing but marketing tricks?

The concept of projections suggests that conventional medicine does look closely enough at the human body, ignoring as of yet undiscovered energy lines and other mysterious linkages. Material testing approaches claim to detect harmful and allergenic components, the removal of which may be beneficial in case of systemic diseases, possibly even curing them. Beginning on July 1, 2018, the use of amalgam will be strongly restricted all throughout Europe. This easy-to-use material has received much attention for decades, as it contains a large proportion of mercury, which is known for its high neurotoxicity, and is, therefore, suspected of causing illness in the long term.

Normally, we think of projections as requiring a screen, onto which something then can be projected. Teeth, however, are also ideally suited as a dumping ground for the underlying causes of somatic and/or mental diseases, from where they can radiate out as so-called projections. Once these are identified as the true cause of disease, other potential causes such as age-related wear and tear, detrimental behaviors, or harmful eating habits can be readily ignored. This concept of projections may have particularly harmful and negative consequences in patients with tumors, as it may cause feelings of guilt, although in many cases no definite cause of tumor development can be discerned. Projected feelings of guilt, in turn, can be a negative influence on a person’s health.

The so-called “system of meridians” assigns relationship qualities to individual teeth, meaning that there are strict relationships of individual teeth to the body’s organs and individual entities. [1]

According to this system, an inflammation of the urinary bladder would be related to the number 1 teeth, the incisors. Rheumatism is linked to the number 8 teeth, the wisdom teeth. In between, there are the teeth of the ordinal numbers 2 to 7, distinguished by their locations on the left or right, in the upper or lower jaw, which offer a wealth of opportunities to assign a “guilty tooth” to clinically common physical complaints. However, this mysterious connection is postulated not only for teeth and major organs, but also for joints, vertebral levels, sensory organs, tonsils, and glands, with the relationships neatly organized in ten groups and subgroups. Multiplied by the number of teeth—eight per each of the four quadrants, 32 in total—these afford the “holistic dentist” 320 opportunities for projecting physical complaints ranging from asthma to zonulitis onto a tooth. Those who believe in this system of projections are not deterred by the fact that there is no scientific proof whatsoever for this odd thesis.

On the other hand, it is basic medical knowledge that pathogens may spread hematogenically and affect remote organs. Seeking adequate specialist counsel when dealing with rheumatic diseases, fevers of unclear etiology, or in conjunction with orthopedic joint surgeries, is, therefore, mandated by guidelines and an obvious standard in the practice of medicine. So-called alternative dentistry makes no particular mention of these general facts, but instead focuses on occult-seeming correlations in order to use a mysterious, almost conspiratorial idea of a disease to legitimize the often invasive treatment options it then recommends. Most patients will not realize that these interpretations often mistake synchronicity for causality. For example, most infections of the urinary bladder will resolve over time, regardless of whether any work was done on the upper incisors or not. However, if during the period of healing one of the incisors was treated by a dentist, it is easy enough to associate this treatment with the resolving bladder infection. From a psychological viewpoint, this constitutes a simple manipulation technique, applied to demonstrate the seemingly superior diagnostics of alternative dentistry: a simple, and easily recognized marketing strategy.

When asked what would happen to these doubtful projections in case of an autologous transplantation during which a tooth would move to another tooth’s original place in the jaw, three leading representatives of the so-called alternative dentistry answered in an evasive and even manipulative manner. [2]

There are reports of invasive therapies, conducted following dubious, often electromedical diagnostic procedures, that not only lead to high costs for the repair of the damage they caused, but also to a lasting mutilation of the patients’ jaws and dentitions. [3-6]

Another supposedly holistic school of thought that is similar to that of the system of meridians exists in some fields of dentistry regarding temporo-mandibular joint dysfunction (TMJD, TMD). These theories suggest that a disbalance in the interaction between jaw bones and masticatory muscles may be responsible for all kinds of diseases. [7]

According to the German self-appointed “TMJD Umbrella Organization” (CMD-Dachverband e. V.), TMJD is a “multifaceted disease.” The claim is that TMJD may not only cause back pain, vertigo, and tinnitus, but also sleep apnea, snoring, neck and shoulder pain, hip and knee pain, headaches, migraines, visual, mood swings, and even depression. However, there is no scientific evidence for any of these claims. [8,9]

Jens C. Türp of the University Center for Dental Medicine Basel’s Department of Oral Health & Medicine, Division Temporomandibular Disorders and Orofacial Pain, has called this standard diagnosis, offered by TMJD diagnosticians whenever a patient shows signs of nocturnal teeth grinding, “nonsense that makes your hair stand on end.”

“For a variety of general symptoms, it is claimed that they are caused by a TMJD: Tinnitus, ocular pressure, differences in the lengths of a person’s legs, back pain, hip pain, and knee pain, balance disorders, tingling in the fingers and many more. ‘A relationship [with TMJD] has never been proven for any of these symptoms’, says Türp. According to him, true TMJD causes problems with chewing and pain. Affected patients have difficulties opening their mouth wide or closing it fully. The “CMD-Arztsuche” (Find a TMJD Specialist) website recommends ‘a lasting correction of a person’s bite’ as treatment. This should be achieved with the help of ceramic inlays, dental crowns, and implants— all of which are expensive and unnecessary measures, in the opinion of Jens Türp. He treats his TMJD patients–almost always successfully, as he says–with occlusal splints, physiotherapy, and relaxation exercises.” (Translated from German [10])

In general, any patient should be advised, therefore, to seek a second opinion whenever confronted with a diagnosis requiring invasive treatments.

References:

1. Madsen, H. Studie zur Kieferorthopädie in der Alternativmedizin: Darstellung der Grundlagen und kritische Bewertung. Doctoral dissertation, Poliklinik für Kieferorthopädie der Universität Würzburg. Würzburg 1994

2. Schulte von Drach, M.C. Wenn Zähne fremdgehen. Süddeutsche Zeitung May 15, 2012.

3. Staehle, H.J. Der Patientin wurde das Gebiss verstümmelt. Zahnärztliche Mitteilungen 2000.

4. Dowideit, A. Wenn nach der “Störfeld-Messung” alle Backenzähne fehlen. Welt June 3, 2017.

5. Bertelsen, H.-W. Die Attraktvität “ganzheitlicher” Zahnmedizin – Teil 1: Bohren ohne Reue. skeptiker 2012, 4.

6. Bertelsen, H.-W. Die Attraktivität “ganzheitlicher” Zahnmedizin – Teil 2: Bohren ohne Reue. skeptiker 2013, 4.

7. CMD Dachverband e. V. Craniomandibuläre Dysfunktion – Ursachen & Symptome. http://www.cmd-dachverband.de/fuer-patienten/ursachen-symptome/ (May 11, 2018),

8. Wolf, T. Die richtige Hilfe bei Kieferbeschwerden. Spiegel Online July 7, 2014, 2014.

9. Türp, J.C.; Schindler, H.-J.; Antes, G. Temporomandibular disorders: Evaluation of the usefulness of a self-test questionnaire. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2013, 107, 285-290.

10. Albrecht, B. Teure Tricks der Zahnärzte – so schützen Sie sich vor Überbehandlung. stern February 18, 2016.

 

I have often cautioned my readers about the ‘evidence’ supporting acupuncture (and other alternative therapies). Rightly so, I think. Here is yet another warning.

This systematic review assessed the clinical effectiveness of acupuncture in the treatment of postpartum depression (PPD). Nine trials involving 653 women were selected. A meta-analysis demonstrated that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group. Regarding the HAMD and EPDS scores, no difference was found between the two groups. The Chinese authors concluded that acupuncture appears to be effective for postpartum depression with respect to certain outcomes. However, the evidence thus far is inconclusive. Further high-quality RCTs following standardised guidelines with a low risk of bias are needed to confirm the effectiveness of acupuncture for postpartum depression.

What a conclusion!

What a review!

What a journal!

What evidence!

Let’s start with the conclusion: if the authors feel that the evidence is ‘inconclusive’, why do they state that ‘acupuncture appears to be effective for postpartum depression‘. To me this does simply not make sense!

Such oddities are abundant in the review. The abstract does not mention the fact that all trials were from China (published in Chinese which means that people who cannot read Chinese are unable to check any of the reported findings), and their majority was of very poor quality – two good reasons to discard the lot without further ado and conclude that there is no reliable evidence at all.

The authors also tell us very little about the treatments used in the control groups. In the paper, they state that “the control group needed to have received a placebo or any type of herb, drug and psychological intervention”. But was acupuncture better than all or any of these treatments? I could not find sufficient data in the paper to answer this question.

Moreover, only three trials seem to have bothered to mention adverse effects. Thus the majority of the studies were in breach of research ethics. No mention is made of this in the discussion.

In the paper, the authors re-state that “this meta-analysis showed that the acupuncture group had a significantly greater overall effective rate compared with the control group. Moreover, acupuncture significantly increased oestradiol levels compared with the control group.” This is, I think, highly misleading (see above).

Finally, let’s have a quick look at the journal ‘Acupuncture in Medicine’ (AiM). Even though it is published by the BMJ group (the reason for this phenomenon can be found here: “AiM is owned by the British Medical Acupuncture Society and published by BMJ”; this means that all BMAS-members automatically receive the journal which thus is a resounding commercial success), it is little more than a cult-newsletter. The editorial board is full of acupuncture enthusiasts, and the journal hardly ever publishes anything that is remotely critical of the wonderous myths of acupuncture.

My conclusion considering all this is as follows: we ought to be very careful before accepting any ‘evidence’ that is currently being published about the benefits of acupuncture, even if it superficially looks ok. More often than not, it turns out to be profoundly misleading, utterly useless and potentially harmful pseudo-evidence.


Reference

Acupunct Med. 2018 Jun 15. pii: acupmed-2017-011530. doi: 10.1136/acupmed-2017-011530. [Epub ahead of print]

Effectiveness of acupuncture in postpartum depression: a systematic review and meta-analysis.

Li S, Zhong W, Peng W, Jiang G.

They say that minds are like parachutes – they function only when open. Having an open mind means being receptive to new and different ideas or the opinions of others.

I am regularly accused of lacking this quality. Most recently, an acupuncturist questioned whether acupuncture-sceptics, and I in particular, have an open mind. Subsequently, an interesting dialogue ensued:

___________________________________________________________

Tom Kennedy on Wednesday 01 August 2018 at 19:27

@Rich It sounds to me as if you are at least partly open-minded, and take a more genuinely scientific approach than most here – i.e. rather than dismissing something with a lot of intriguing evidence behind it (even if much of this evidence is still hotly debated) mainly on the grounds that it ‘sounds a bit silly’, you understand that it’s possible to look at something like acupuncture objectively without being put off by the strange terminology associated with it. I strongly urge you to consult various other outlets as well as this one before coming to any final judgement. http://www.evidencebasedacupuncture.org/ for example is run by intelligent people genuinely trying to present the facts as they see them. Yes, they have an ‘agenda’ in that they are acupuncturists, but I can assure you, having had detailed discussions with some of them, that they are motivated by the urge to see acupuncture help more people rather than anything sinister, and they are trying to present an honest appraisal of the evidence. No doubt virtually everyone here will dismiss everything there with (or without) a cursory glance, but perhaps you won’t fall into that category. I hope you find something of interest there, and come to a balanced opinion.

the EVIDENCEBASEDACUPUNCTURE site you recommend quotes the Vickers meta-analysis thus:
“A meta-analysis of 17,922 patients from randomized trials concluded, “Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo.”
Pity that they forgot a bit. The full conclusion reads:
“Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”
AND YOU TRY TO LECTURE US ABOUT AN OPEN MIND?

@Edzard I’m not sure I understand your point. ‘However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.’ Perhaps the full conclusion should always be quoted, but I don’t think that addendum changes the context significantly. Acupuncture has been shown to be more than a placebo in a large meta-analysis (when compared to arguably active sham controls). The authors put it well I think, in the ‘Interpretation’ section:

‘Our finding that acupuncture has effects over and above sham acupuncture is therefore of major importance for clinical practice. Even though on average these effects are small, the clinical decision made by doctors and patients is not between true and sham acupuncture, but between a referral to an acupuncturist or avoiding such a referral. The total effects of acupuncture, as experienced by the patient in routine practice, include both the specific effects associated with correct needle insertion according to acupuncture theory, non-specific physiologic effects of needling, and non-specific psychological (placebo) effects related to the patient’s belief that treatment will be effective.’

Compare this to Richard’s comment here, for example: ‘Of course the effects of ‘acupuncture’ (if any) are due to placebo responses (and perhaps nocebo responses in some cases). What else?’. And your post tile includes the line ‘the effects of acupuncture are due to placebo’. These are the kinds of comment that to me seem closed-minded in the face of some significant evidence.

edzard on Thursday 02 August 2018 at 12:46

“Perhaps the full conclusion should always be quoted…”

YES, IF NOT, IT’S CALLED ‘BEING ECONOMICAL WITH THE TRUTH’

“…I don’t think that addendum changes the context significantly.”
IT’S NOT AN ADDENDUM, BUT PART OF THE CONCLUSION; AND YOU ARE WRONG, FOR ME, IT CHANGES A LOT.
“…your post tile includes the line ‘the effects of acupuncture are due to placebo’.”
BECAUSE THIS IS WHAT THE PAPER DISCUSSED IN THAT PARTICULAR POST IMPLIED.

I think you need a new keyboard – the caps key seems to be stuck.

‘IT’S CALLED ‘BEING ECONOMICAL WITH THE TRUTH’’

The title of this post is: ‘Yet another confirmation: the effects of acupuncture are due to placebo’. That’s also being economical with the truth I think. You argue ‘BECAUSE THIS IS WHAT THE PAPER DISCUSSED IN THAT PARTICULAR POST IMPLIED’, but is it? The authors state ‘Future studies are needed to confirm or refute any effects of acupuncture in acute stroke’, and that would have been a much more balanced headline. You clearly imply here that it has been CONFIRMED that the effects of acupuncture are due to placebo, and that this trial is further confirmation. This is misleading at best. Yes, you add in brackets ‘(for acute stroke)’ at the end of the post, but why not in the title, unless you want to give the impression this is true for acupuncture in general

Edzard on Thursday 02 August 2018 at 14:09

my post is about critical evaluation of the published literature.
and this is what follows from a critical evaluation of this particular article.
I am not surprised that you cannot follow this line of reasoning.
could it be that the lack of an open mind is not my but your problem

Tom Kennedy on Thursday 02 August 2018 at 14:43

‘could it be that the lack of an open mind is not my but your problem?’

Who knows, maybe the problem is both of ours? I’m open to all possibilities!

VERY GOOD!
ok, let’s have a look.
you 1st: learnt acupuncture [a therapy that relies on a 2000 year old dogma], never published anything negative about it, never used any other therapeutic modality, even treated my own daughter with acupuncture when she suffered from infant colic, earn my livelihood by doing acupuncture.
[I MIGHT BE WRONG HERE, AS I DON’T KNOW ALL THAT MUCH ABOUT YOU, SO PLEASE CORRECT ME] me next: studied acupuncture during my time in med school, used it occasionally, learnt to use dozens of other therapeutic modalities, published lots about acupuncture based on the current evidence [this means that some conclusions – even of my Cochrane reviews – were positive but have since changed], worked with acupuncturists from across the globe, published one book about acupuncture together with several acupuncture fans, now dedicate my time to the critical analysis of the literature and bogus claims, have no conflicts of interest.
[IN CASE YOU KNOW MORE RELEVANT THINGS ABOUT ME, PLEASE ADD]

@Edzard Your summaries seem to be more or less accurate. However, a) I wouldn’t agree with your use of the term ‘dogma’; b) I haven’t published any scientific papers, but I’ve acknowledged various problems in the acupuncture field through informal pieces; c) I’ve used other CAM modalities, and I’ve directly or indirectly experienced many conventional modalities; d) I only earn part of my livelihood by doing acupuncture. Yes, my background makes it more likely that I’ll be biased in favour of acupuncture. But your credentials in no way guarantee open-mindedness on the subject, and personally I don’t see that displayed often on this blog. It still makes for interesting and stimulating reading though.

what problems in the acupuncture field have you acknowledged through informal pieces?
can you provide links?
I want to get a feel for the openness of your mind.
“…your credentials in no way guarantee open-mindedness on the subject, and personally I don’t see that displayed often on this blog.”
1) you seem to forget that blog-posts are not scientific papers, not even close.
2) you also forget that my blog is dedicated to the CRITICAL assessment of alt med.
finally, what would make you think that someone has an open mind towards acupuncture, if not the fact that someone has a track record of publishing positive conclusions about it when the evidence allows?
remember: an open mind should not be so open that your brain falls out!

Tom Kennedy on Friday 03 August 2018 at 11:20

Here’s one example: https://www.tomtheacupuncturist.com/blog/2017/2/24/does-acupuncture-really-work

‘what would make you think that someone has an open mind towards acupuncture, if not the fact that someone has a track record of publishing positive conclusions about it when the evidence allows?’

I think there’s plenty of evidence that allows for positive conclusions about acupuncture, but you don’t report these. I understand the slant of this blog, but I’d say it comes across as ‘negative assessment’ rather than ‘critical assessment’. Perhaps you’ll argue that your critical assessment has led you to a negative assessment? I’ll just have to disagree that that’s a fair and open-minded summary of the evidence.

Out of interest, can I ask what your acupuncture training involved (hours, theory, clinic time etc.)?

I am sorry to say that I see no critical evaluation in the post you linked to.
” I’d say it comes across as ‘negative assessment’ rather than ‘critical assessment’.
have you noticed that criticism is often experienced as negative to the person(s) it is aimed at?

Tom Kennedy on Friday 03 August 2018 at 12:55

‘I am sorry to say that I see no critical evaluation in the post you linked to’

I’ll just have to live with that. I feel as though it acknowledges some of the problems in the acupuncture world, in an attempt at balance. I don’t feel your posts aim for balance, but as you said, a blog isn’t a scientific paper so it’s your prerogative to skew things as you see fit

Edzard on Friday 03 August 2018 at 13:18

it seems to me that the ‘screwing things as you see fit’ is your game.

____________________________________________________________________

This exchange shows how easily I can be provoked to get stroppy and even impolite – I do apologise.

But it also made me wonder: how can anyone be sure to have an open mind?

And how can we decide that a person has a closed mind?

We probably all think we are open minded, but are we correct?

I am not at all sure that I know the answer. It obviously depends a lot on the subject. There are subjects where one hardly needs to keep an open mind and some where it might be advisable to have a closed mind:

  • the notion that the earth is flat,
  • flying carpets,
  • iridology,
  • reflexology,
  • chiropractic subluxation,
  • the vital force,
  • detox,
  • homeopathy.

No doubt, there will be people who even disagree with this short list.

Something that intrigues me – and I am here main ly talking about alternative medicine – is the fact that I often get praised by people who say, “I do appreciate your critical stance on therapy X, but on my treatment Y you are clearly biased and unfairly negative!” To me, it is an indication of a closed mind, if criticism is applauded as long as it does not tackle someone’s own belief system.

On the subject of homeopathy, Prof M Baum and I once published a paper entitled ‘Should we maintain an open mind about homeopathy?’ Its introduction explains the problem quite well, I think:

Once upon a time, doctors had little patience with the claims made for alternative medicines. In recent years the climate has changed dramatically. It is now politically correct to have an open mind about such matters; “the patient knows best” and “it worked for me” seem to be the new mantras. Although this may be a reasonable approach to some of the more plausible aspects of alternative medicine, such as herbal medicine or physical therapies that require manipulation, we believe it cannot apply across the board. Some of these alternatives are based on obsolete or metaphysical concepts of human biology and physiology that have to be described as absurd with proponents who will not subject their interventions to scientific scrutiny or if they do, and are found wanting, suggest that the mere fact of critical evaluation is sufficient to chase the healing process away. These individuals have a conflict of interest more powerful than the requirement for scientific integrity and yet defend themselves by claiming that those wanting to carry out the trials are in the pocket of the pharmaceutical industry and are part of a conspiracy to deny their patients tried and tested palliatives….

END OF QUOTE

And this leads me to try to define 10 criteria indicative for an open mind.

  1. to be free of conflicts of interest,
  2. integrity,
  3. honesty,
  4. to resist the temptation of applying double standards,
  5. to have a track record of having changed one’s views in line with the evidence,
  6. to not cling to overt absurdities,
  7. to reject conspiracy theories,
  8. to be able to engage in a meaningful dialogue with people who have different views,
  9. to avoid fallacious thinking,
  10. to be willing to learn more on the subject in question.

I would be truly interested to hear, if you have further criteria, or indeed any other thoughts on the subject.

Needle acupuncture in small children is controversial, not least because the evidence that it works is negative or weak, and because small children are unable to consent to the treatment. Yet it is recommended by some acupuncturists for infant colic. This, of course, begs the questions:

  1. Does the best evidence tell us that acupuncture is effective for infant colic?
  2. Are acupuncturists who recommend acupuncture for this condition responsible and ethical?

This systematic review and a blinding-test validation based on individual patient data from randomised controlled trials was aimed to assess its efficacy for treating infantile colic. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson’s chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents].

The investigators included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9 min at mid-treatment, -11.4 min at the end of treatment and -11.8 min at the 4-week follow-up. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8 min. The registration of crying during treatment suggested more crying during acupuncture.

The authors concluded that percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis.

The authors also provide this further comment: “Our blinding test validated IPD meta-analysis of minimal acupuncture treatments of infantile colic did not show clinically relevant effects in pain reduction as estimated by differences in crying time between needle acupuncture intervention and no acupuncture control. Analyses indicated that acupuncture treatment induced crying in many of the children. Caution should therefore be exercised in recommending potentially painful treatments with uncertain efficacy in infants. The studies are few, the analysis is made on small samples of individuals, and conclusions should be considered in this context. With this limitation in mind, our findings do not support the idea that percutaneous needle acupuncture should be recommended for treatment of infantile colic on a general basis.”

So, returning to the two questions that I listed above – what are the answers?

I think they must be:

  1. No.
  2. No.
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