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

acupuncture

Patients with rheumatoid arthritis (RA) have a higher risk of coronary heart disease (CHD). Despite good evidence for effectiveness, acupuncture is often advocated for RA, and it has not been reported to prevent CHD in patients with RA.

The authors of this analysis aimed to assess the risk of developing CHD in acupuncture-users and non-users of patients with RA. They identified 29,741 patients with newly diagnosed RA from January 1997 to December 2010 from the Registry of Catastrophic Illness Patients Database from the Taiwanese National Health Insurance Research Database. Among them, 10,199 patients received acupuncture (acupuncture users), and 19,542 patients did not receive acupuncture (no-acupuncture users). After performing 1:1 propensity score matching by sex, age, baseline comorbidity, conventional treatment, initial diagnostic year, and index year, there were 9932 patients in both the acupuncture and no-acupuncture cohorts. The main outcome was the diagnosis of CHD in patients with RA in the acupuncture and no-acupuncture cohorts.

Acupuncture users had a lower incidence of CHD than non-users (adjusted HR = 0.60, 95% CI = 0.55-0.65). The estimated cumulative incidence of CHD was significantly lower in the acupuncture cohort (log-rank test, p < .001). Subgroup analysis showed that patients receiving manual acupuncture of traditional Chinese medicine style, electroacupuncture, or combination of both all had a lower incidence of CHD than patients never receiving acupuncture treatment. The beneficial effect of acupuncture on preventing CHD was independent of age, sex, diabetes mellitus, hypertension, hyperlipidemia, and statins use.

The authors concluded that this is the first large-scale study to reveal that acupuncture might have beneficial effect on reducing the risk of CHD in patients with RA. This study may provide useful information for clinical utilization and future studies.

Pigs might fly, but – call me a sceptic – I somehow doubt it almost as much as I doubt that acupuncture might have beneficial effect on reducing the risk of CHD.

Why?

Because of two reasons mainly:

  1. For the life of me, I cannot see a mechanism by which acupuncture achieves this extraordinary feast (the authors allege an anti-inflammatory effect of acupuncture which I find wholly unconvincing).
  2. There is a much simpler explanation for the observed outcomes.

The propensity score used here did, of course, only match the groups for a hand-full of factors. Yet there are many more that could play a part which the authors could not consider because they did not have the data to do so. The one that foremost comes to my mind is a generally healthier life-style of the patients using acupuncture. I think it stands to reason that people who bother to have and pay for an additional treatment are higher motivated to adhere to a life-style (e. g. smoking-cessation, exercise, nutrition, stress) that reduces the CHD-risk. And the influence of this factor could be very significant indeed. As the devil’s advocate, I could therefore even postulate that acupuncture itself had a slightly detrimental effect which, however, was over-ridden by the massive effect of the healthier life-style.

And the lesson to learn from all this?

Before we conclude about ‘beneficial effects’ of acupuncture or any other therapy, we need RCTs that effectively eliminate these rather obvious confounders.

 

Carpal tunnel syndrome (CTS) is caused by the tendons in the wrist getting too tight and thus putting pressure on the nerves that run beneath them. The symptoms can include:

  • pain in fingers, hand or arm,
  • numb hands,
  • tingling or ‘pins and needles’,
  • a weak thumb or difficulty gripping.

These symptoms often start slowly and they can come and go but often get worse over time. They are usually worse at night and may keep patients from having a good night’s sleep.

The treatments advocated for CTS include painkillers, splints and just about every alternative therapy one can think of, particularly acupuncture. Acupuncture may be popular, but does it work?

This new Cochrane review was aimed at assessing the evidence for acupuncture and similar treatments for CTS. It included 12 studies with 869 participants. Ten studies reported the primary outcome of overall clinical improvement at short‐term follow‐up (3 months or less) after randomisation. Most studies could not be combined in a meta‐analysis due to heterogeneity, and all had an unclear or high overall risk of bias. Only 7 studies provided information on adverse events.

The authors (two of them are from my former Exeter team) found that, in comparison with placebo or sham-treatments, acupuncture and laser acupuncture have little or no effect in the short term on symptoms of CTS. It is uncertain whether acupuncture and related interventions are more or less effective in relieving symptoms of CTS than corticosteroid nerve blocks, oral corticosteroids, vitamin B12, ibuprofen, splints, or when added to NSAIDs plus vitamins, as the certainty of any conclusions from the evidence is low or very low and most evidence is short term. The included studies covered diverse interventions, had diverse designs, limited ethnic diversity, and clinical heterogeneity.

The authors concluded that high‐quality randomised controlled trials (RCTs) are necessary to rigorously assess the effects of acupuncture and related interventions upon symptoms of CTS. Based on moderate to very‐low certainty evidence, acupuncture was associated with no serious adverse events, or reported discomfort, pain, local paraesthesia and temporary skin bruises, but not all studies provided adverse event data.

This last point is one that I made very often: most trials of acupuncture fail to report adverse effects. This is doubtlessly unethical (it gives a false-positive overall impression about acupuncture’s safety). And what can you do with studies that are unethical? My answer is simple: bin them!

Most of the trials were of poor or very poor quality. Such studies tend to generate false-positive results. And what can you do with studies that are flimsy and misleading? My answer is simple: bin them!

So, what can we do with acupuncture trials of CTS? … I let you decide.

But binning the evidence offers little help to patients who suffer from chronic, progressive CTS. What can those patients do? Go and see a surgeon! (S)he will cure you with a relatively simply and safe operation; in all likelihood, you will never look back at dubious treatments.

The most frequent of all potentially serious adverse events of acupuncture is pneumothorax. It happens when an acupuncture needle penetrates the lungs which subsequently deflate. The pulmonary collapse can be partial or complete as well as one or two sided. This new case-report shows just how serious a pneumothorax can be.

A 52-year-old man underwent acupuncture and cupping treatment at an illegal Chinese medicine clinic for neck and back discomfort. Multiple 0.25 mm × 75 mm needles were utilized and the acupuncture points were located in the middle and on both sides of the upper back and the middle of the lower back. He was admitted to hospital with severe dyspnoea about 30 hours later. On admission, the patient was lucid, was gasping, had apnoea and low respiratory murmur, accompanied by some wheeze in both sides of the lungs. Because of the respiratory difficulty, the patient could hardly speak. After primary physical examination, he was suspected of having a foreign body airway obstruction. Around 30 minutes after admission, the patient suddenly became unconscious and died despite attempts of cardiopulmonary resuscitation.

Whole-body post-mortem computed tomography of the victim revealed the collapse of the both lungs and mediastinal compression, which were also confirmed by autopsy. More than 20 pinprick injuries were found on the skin of the upper and lower back in which multiple pinpricks were located on the body surface projection of the lungs. The cause of death was determined as acute respiratory and circulatory failure due to acupuncture-induced bilateral tension pneumothorax.

The authors caution that acupuncture-induced tension pneumothorax is rare and should be recognized by forensic pathologists. Postmortem computed tomography can be used to detect and accurately evaluate the severity of pneumothorax before autopsy and can play a supporting role in determining the cause of death.

The authors mention that pneumothorax is the most frequent but by no means the only serious complication of acupuncture. Other adverse events include:

  • central nervous system injury,
  • infection,
  • epidural haematoma,
  • subarachnoid haemorrhage,
  • cardiac tamponade,
  • gallbladder perforation,
  • hepatitis.

No other possible lung diseases that may lead to bilateral spontaneous pneumothorax were found. The needles used in the case left tiny perforations in the victim’s lungs. A small amount of air continued to slowly enter the chest cavities over a long period. The victim possibly tolerated the mild discomfort and did not pay attention when early symptoms appeared. It took 30 hours to develop into symptoms of a severe pneumothorax, and then the victim was sent to the hospital. There he was misdiagnosed, not adequately treated and thus died. I applaud the authors for nevertheless publishing this case-report.

This case occurred in China. Acupuncturists might argue that such things would not happen in Western countries where acupuncturists are fully trained and aware of the danger. They would be mistaken – and alarmingly, there is no surveillance system that could tell us how often serious complications occur.

This systematic review was aimed at evaluating the effects of acupuncture on the quality of life of migraineurs.  Only randomized controlled trials that were published in Chinese and English were included. In total, 62 trials were included for the final analysis; 50 trials were from China, 3 from Brazil, 3 from Germany, 2 from Italy and the rest came from Iran, Israel, Australia and Sweden.

Acupuncture resulted in lower Visual Analog Scale scores than medication at 1 month after treatment and 1-3 months after treatment. Compared with sham acupuncture, acupuncture resulted in lower Visual Analog Scale scores at 1 month after treatment.

The authors concluded that acupuncture exhibits certain efficacy both in the treatment and prevention of migraines, which is superior to no treatment, sham acupuncture and medication. Further, acupuncture enhanced the quality of life more than did medication.

The authors comment in the discussion section that the overall quality of the evidence for most outcomes was of low to moderate quality. Reasons for diminished quality consist of the following: no mentioned or inadequate allocation concealment, great probability of reporting bias, study heterogeneity, sub-standard sample size, and dropout without analysis.

Further worrisome deficits are that only 14 of the 62 studies reported adverse effects (this means that 48 RCTs violated research ethics!) and that there was a high level of publication bias indicating that negative studies had remained unpublished. However, the most serious concern is the fact that 50 of the 62 trials originated from China, in my view. As I have often pointed out, such studies have to be categorised as highly unreliable.

In view of this multitude of serious problems, I feel that the conclusions of this review must be re-formulated:

Despite the fact that many RCTs have been published, the effect of acupuncture on the quality of life of migraineurs remains unproven.

 

The public is often impressed by scenes shown on TV where surgeons in China operate patients apparently with no other anaesthesia than acupuncture. Such films have undoubtedly contributed significantly to the common belief that acupuncture cannot possibly be a placebo (every single time I give a public talk about acupuncture, the issue comes up, and someone asks me: how can you doubt the efficacy of acupuncture when, in China, they use it for major operations?).

Some years ago, I have myself been involved is such a BBC broadcast and had to learn the hard way that such scenes are more than just a bit misleading.

Unfortunately, the experts rarely object to any of this. They seem to have become used to the false claims and overt propaganda that is rife in the promotion of acupuncture, and have resigned to the might of poor journalism.

The laudable exception is a team of French authors of a recent and excellent paper.

This unusual article analysed a clip from the program “Acupuncture, osteopathy, hypnosis: do complementary medicines have superpowers?” about acupuncture as an anaesthetic for surgical procedures in China. Their aim was to propose a rational explanation for the phenomena observed and to describe the processes leading a public service broadcasting channel to offer this type of content at prime time and the potential consequences in terms of public health. For this purpose, they used critical thinking attitudes and skills, along with a bibliographical search of Medline, Google Scholar and Cochrane Library databases.

Their results reveal that the information delivered in the television clip is ambiguous. It did not allow the viewer to form an informed opinion on the relevance of acupuncture as an anaesthetic for surgical procedures. It is reasonable to assume that the clip shows surgery performed with undisclosed epidural anaesthesia coupled with mild intravenous anaesthesia, sometimes performed in other countries.

What needs to be highlighted, the authors of this critique state, is the overestimation of acupuncture added to the protocol. The media tend to exaggerate the risks and expected effects of the treatments they report on, which can lead patients to turn to unproven therapies.

The authors concluded that broadcasting such a clip at prime time underlines the urgent need for the public and all health professionals to be trained in sorting and critically analysing health information.

In my view, broadcasting such misleading films also underlines the urgent need for journalists to be conscious of their responsibility not to mislead the public and do more rigorous research before reporting on matters of health.

Back pain is a huge problem: it affects many people, causes much suffering and leads to extraordinary high cost for all of us. Considering these facts, it would be excellent to identify a treatment that truly works. However, at present, we do not have found the ideal therapy; instead we have dozens of different approaches that are similarly effective/ineffective. Two of these therapies are massage and acupuncture.

Is one better than the other?

This study compared the efficacy of classical massage (KMT, n = 66) with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain (“Von Korff”-Questionnaire) at the follow-up after one month.

In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).

The authors concluded that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.

I find such studies oddly useless.

To conduct a controlled trial, one needs an experimental treatment (the therapy that is not understood) and compare it with an intervention that is understood (such as a placebo that has no specific effects, or a treatment that has been shown to work). In comparative studies like the one above, one compares one unknown with another unknown. I do not see how such a comparison can ever produce a meaningful result.

In a way, it is like an equation with two unknowns: x + 5 = y. It is simply not possible to define either x nor y, and the equation is unsolvable.

For comparative studies of two back-pain treatments to make sense, we would need one of which the effect size is well-established. I do not think that we currently have identified such a therapy. Certainly, we cannot say that we know it for massage or acupuncture.

In other words, comparative studies like the one above are a waste of resources that cannot possibly make a meaningful contribution to our knowledge.

To put it even more bluntly: we ought to stop such pseudo-research.

Acupuncture is a branch of alternative medicine where pseudo-science abounds. Here is yet another example of this deplorable phenomenon.

This study was conducted to evaluate the efficacy of acupuncture in the management of primary dysmenorrhea.

Sixty females aged 17-23 years were randomly assigned to either a study group or a control group.

  • The study group received acupuncture for the duration of 20 minutes/day, for 15 days/month, for the period of 90 days.
  • The control group did not receive acupuncture for the same period.

Both groups were assessed on day 1; day 30 and day 60; and day 90. The results showed a significant reduction in all the variables such as the visual analogue scale score for pain, menstrual cramps, headache, dizziness, diarrhoea, faint, mood changes, tiredness, nausea, and vomiting in the study group compared with those in the control group.

The authors concluded that acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea.

These findings contradict those of a recent Cochrane review (authored by known acupuncture-proponents) which included 42 RCTs and concluded that there is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.

The question that I ask myself is this: why do researchers bother to conduct studies that contribute NOTHING to our knowledge and progress? The new study had a no-treatment control group which means it cannot control for the effects of placebo, the extra attention, social desirability etc. In view of the fact that already 42 poor quality trials exist, it is not just useless to add a 43rd but, in my view, it is scandalous! A 43rd useless trial:

  • tells us nothing of value;
  • misleads the public;
  • pollutes the medical literature;
  • is a waste of resources;
  • undermines the trust in clinical research;
  • is deeply unethical.

It is high time to stop such redundant, foolish, wasteful and unethical pseudo-science.

 

According to the 2014 European Social Survey, Spain is relatively modest when it comes to using alternative therapies. While countries such as Austria, Denmark, Estonia, Finland, France, Germany, Lithuania, Sweden and Switzerland all have 1-year prevalence figures of over 30%, Spain only boasts a meagre 17%. Yet, its opposition to bogus treatments has recently become acute.

In 2016, it was reported that a master’s degree in homeopathic medicine at one of Spain’s top universities has been scrapped. Remarkably, the reason was “lack of scientific basis”. A university spokesman confirmed the course was being discontinued and gave three main reasons: “Firstly, the university’s Faculty of Medicine recommended scrapping the master’s because of the doubt that exists in the scientific community. Secondly, a lot of people within the university – professors and students across different faculties – had shown their opposition to the course. Thirdly, the postgraduate degree in homeopathic medicine is no longer approved by Spain’s Health Ministry.”

A few weeks ago, I had the great pleasure of being invited to a science festival in Bilbao and was impressed by the buoyant sceptic movement in Spain. At the time, two of my books were published in Spanish and received keen interest by the Spanish press.

 

And now, it has been reported that Spain’s Ministry of Health has released a list of only 2,008 homeopathic products whose manufacturers will have to apply for an official government license for if they wish to continue selling them. The homeopathic producers have until April 2019 to prove that their remedies actually work, which may very well completely slash homeopathic products in Spain.

It’s the latest blow for Spain’s homeopathy industry, once worth an estimated €100 million but which has seen a drop in public trust and therefore sales of around 30 percent in the last five years. Spain’s Health Ministry stopped allowing homeopathy treatments from being prescribed as part of people’s social security benefits, along with acupuncture, herbal medicine and body-based practices such as osteopathy, shiatsu or aromatherapy.

“Homeopathy is an alternative therapy that has not shown any scientific evidence that it works” Spanish Minister of Health Maria Luisa Carcedo is quoted as saying in La Vanguardia in response to the homeopathic blacklist. “I’m committed to combatting all forms of pseudoscience.”

Mini-scalpel acupuncture or acupotomy is a relatively new type of non-invasive acupuncture/ micro surgery using a small needle-scalpel invented by Professor Zhu Hanzhang around 30 years ago in China. It is a slightly thicker and more blunt instrument that gets under the skin and is able to break apart adhesions and muscle knots more effectively than a regular acupuncture needle would.

Sounds weird?

Never mind, the question is does it work!

A systematic review showed that almost all studies reported an effect of acupotomy on joint pain compared to a variety of controls. On reflection, this is hardly surprising:

  • all the trials were from China;
  • all had major methodological flaws.

This means that we need better studies to decide the efficacy question.

This new study investigated the efficacy and safety of mini-scalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial.

Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment).

Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. There were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits.

The authors concluded that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.

I can recommend this article to anyone who wants a quick introduction into the critical analysis of clinical trials. It is a veritable treasure trove of mistakes, flaws, errors, fallacies etc. Here are just a few:

  • The authors aim of investigating the safety of MA is unobtainable. It would require not 24 but probably 24 000 patients.
  • The authors aim of investigating the efficacy of MA is equally unobtainable. It would require a much larger sample than 24, a sham control arm, identical treatment schedules, patient-blinding, etc.
  • Calling the trial a ‘pilot’ is endearing but, except for the title and the insufficient sample size, this study has none of the characteristics of a pilot study.
  • In their ‘introduction’, the authors state that miniscalpel acupuncture (MA) is a new subtype of acupuncture that is effective in treating chronic soft tissue injuries such as adhesions and contractures. This is clearly wrong but discloses their bias very plainly.
  • The authors statement that both MA and acupuncture provide similar effects with regard to pain control in patients with KOA is misleading. It implies that both interventions had specific effects. Without a sham control arm, this is pure speculation.
  • Similarly their assumption that MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments, is pure fantasy.
  • In fact, as MA requires injections of local anaesthetics, any outcome is heavily confounded by this addition.
  • In the discussion section, the authors state that because MA is invasive and provides a strong stimulus, some participants complained of stiff and dull pain for few days after treatment. Yet, when reporting adverse effects in the results section, this was not mentioned.
  • The way this study was designed, it should have been clear from the start that it would not produce any meaningful findings. Seen from this perspective, running the trial could even be seen as a breach of research ethics.
  • According to the aims of a pilot study and the authors hope that their study would provide information for a large-scale randomized controlled trial, all reporting of outcomes is misplaced and should be replaced by information as to how a definitive trial should be conducted.

The following footnote is worth mentioning: This study is supported by a grant from the Ministry of Health & Welfare, Korea. It suggests to me that this ministry should urgently re-think its funding strategy and recruit some reviewers who are capable of critical analysis.

In my view, this is a lousy study which the authors decides to call ‘a pilot’ in order to get it published in a lousy journal.

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.

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