MD, PhD, FMedSci, FSB, FRCP, FRCPEd

acupuncture

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Acupuncture remains a highly controversial treatment: its mechanism of action is less than clear and the clinical results are equally unconvincing. Of course, one ought to differentiate between different conditions; the notion that acupuncture is a panacea is most certainly nonsense.

In many countries, acupuncture is being employed mostly in the management of pain, and it is in this area where the evidence is perhaps most encouraging. Yet, even here the evidence from the most rigorous clinical trials seems to suggest that much, if not all of the effects of acupuncture might be due to placebo.

Moreover, we ought to be careful with generalisations and ask what type of pain? One very specific pain is that caused by aromatase inhibitors (AI), a medication frequently prescribed to women suffering from breast cancer. Around 50 % of these patients complain of AI-associated musculoskeletal symptoms (AIMSS) and 15 % discontinue treatment because of these complaints. So, can acupuncture help these women?

A recent randomised, sham-controlled trial tested whether acupuncture improves AIMSS. Postmenopausal women with early stage breast cancer, experiencing AIMSS were randomized to eight weekly real or sham acupuncture sessions. The investigators evaluated changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scale (VAS). Serum estradiol, β-endorphin, and proinflammatory cytokine concentrations were also measured pre and post-intervention. In total, 51 women were enrolled of whom 47 were evaluable (23 randomized to real and 24 to sham acupuncture).

Baseline characteristics turned out to be balanced between groups with the exception of a higher HAQ-DI score in the real acupuncture group. The results failed to show a statistically significant difference in reduction of HAQ-DI or VAS between the two groups. Following eight weekly treatments, a significant reduction of IL-17 was noted in both groups. No significant modulation was seen in estradiol, β-endorphin, or other proinflammatory cytokine concentrations in either group. No difference in AIMSS changes between real and sham acupuncture was seen.

Even though this study was not large, it was rigorously executed and well-reported. As many acupuncturists claim that their treatment alleviates pain and as many women suffering from AM-induced pain experience benefit, acupuncture advocates will nevertheless claim that the findings of this study are wrong, misleading or irrelevant. The often remarkable discrepancy between experience and evidence will again be the subject of intense discussions. How can a tiny trial overturn the experience of so many?

The answer is: VERY EASILY! In fact, the simplest explanation is that both are correct. The trial was well-done and its findings are thus likely to be true. The experience of patients is equally true – yet it relies not on the effects of acupuncture per se, but on the context in which it is given. In simple language, the effects patients experience after acupuncture are due to a placebo-response.

This is the only simple explanation which tallies with both the evidence and the experience. Once we think about it carefully, we realise that acupuncture is highly placebo-genic:

It is exotic.

It is invasive.

It is slightly painful.

It involves time with a therapist.

It involves touch.

If anyone had the task to develop a treatment that maximises placebo-effects, he could not come up with a better intervention!

Ahhh, will acupuncture-fans say, this means that acupuncture is a helpful therapy. I don’t care how it works, as long as it does help. Did we not just cover this issues in some detail? Indeed we did –  and I do not feel like re-visiting the three fallacies which underpin this sentence again.

According to Wikipedia, Gua sha involves repeated pressured strokes over lubricated skin with a smooth edge placed against the pre-oiled skin surface, pressed down firmly, and then moved downwards along muscles or meridians.This intervention causes bleeding from capillaries and sub-cutaneous blemishing which usually last for several days. According to a recent article on Gua Sha, it is a traditional healing technique popular in Asia and Asian immigrant communities involving unidirectional scraping and scratching of the skin until ‘Sha-blemishes’ appear.

Gua Sha paractitioners make far-reaching therapeutic claims, e.g.” Gua Sha is used whenever a patient has pain whether associated with an acute or chronic disorder… In addition to resolving musculo skeletal pain, Gua Sha is used to treat as well as prevent common cold, flu, bronchitis, asthma, as well as any chronic disorder involving pain, congestion of Qi and Blood“. Another source informs us that ” Gua Sha is performed to treat systemic toxicity, poor circulation, physical and  emotional stress, and migraines. Gua Sha healing promotes the flow of Qi  (energy) and blood throughout the body for overall health“.

Gua Sha “blemishes” can look frightful – more like the result of torture than of treatment. Yet with our current craze for all things exotic in medicine, Gua Sha is becoming popular also in Western countries. One German team has even published several RCTs of Gua Sha.

This group treated 40 patients with neck pain either with Gua Sha or locally applied heat packs. They found that, after one week, the pain was significantly reduced in the former compared to the latter group. The same team also published a study with 40 back or neck-pain patients who either received a single session of Gua Sha or were left untreated. The results indicate that one week later, the treated patients had less pain than the untreated ones.

My favoutite article on the subject must be a case report by the same German research team. It describes a woman suffering from chronic headaches. She was treated with a range of interventions, including Gua Sha – and her symptoms improved. From this course of events, the authors conclude that “this case provides first evidence that Gua Sha is effective in the treatment of headaches”

The truth, of course, is that neither this case nor the two RCTs provide any good evidence at all. The case-report is, in fact, a classic example of drawing hilariously over-optimistic conclusions from data that are everything but conclusive. And the two RCTs  just show how remarkable placebo-effects can be, particularly if the treatment is exotic, impressive, involves physical touch, is slightly painful and raises high expectations.

My explanation for the observed effects after Gua Sha is quite simple: imagine you have a headache and accidentally injure yourself – say you fall off your bike and the tarmac scrapes off an area of skin on your thigh. This hurts quite a bit and distracts you from your headache, perhaps even to such an extend that you do not feel it any more. As the wound heals, it gets a bit infected and thus hurts for several days; chances are that your headache will be gone for that period of time. Of course, the Gua Sha- effect would be larger because the factors mentioned above (exotic treatment, expectation etc.) but essentially the accident and the treatment work via similar mechanisms, namely distraction and counter-irritation. And neither Gua Sha nor injuring yourself on the tarmac are truly recommendable therapies, in my view.

But surely, for the patient, it does not matter how she gets rid of her headache! The main point is that Gua Sha works! In a way, this attitude is understandable – except, we do not need the hocus pocus of meridians, qi, TCM, ancient wisdom etc. nor do we need to tolerate claims that Gua Sha is “serious medicine” and has any specific effects whatsoever. All we do need is to apply some common sense and then use any other method of therapeutic counter-irritation; that might be more honest, safer and would roughly do the same trick.

No, I am wrong! I forgot something important: it would not be nearly as lucrative for the TCM-practitioner.

Would it not be nice to have a world where everything is positive? No negative findings ever! A dream! No, it’s not a dream; it is reality, albeit a reality that exists mostly in the narrow realm of alternative medicine research. Quite a while ago, we have demonstrated that journals of alternative medicine never publish negative results. Meanwhile, my colleagues investigating acupuncture, homeopathy, chiropractic etc. seem to have perfected their strategy of avoiding the embarrassment of a negative finding.

Since several years, researchers in this field have adopted a study-design which is virtually sure to generate nothing but positive results. It is being employed widely by enthusiasts of placebo-therapies, and it is easy to understand why: it allows them to conduct seemingly rigorous trials which can impress decision-makers and invariably suggests even the most useless treatment to work wonders.

One of the latest examples of this type of approach is a trial where acupuncture was tested as a treatment of cancer-related fatigue. Most cancer patients suffer from this symptom which can seriously reduce their quality of life. Unfortunately there is little conventional oncologists can do about it, and therefore alternative practitioners have a field-day claiming that their interventions are effective. It goes without saying that desperate cancer victims fall for this.

In this new study, cancer patients who were suffering from fatigue were randomised to receive usual care or usual care plus regular acupuncture. The researchers then monitored the patients’ experience of fatigue and found that the acupuncture group did better than the control group. The effect was statistically significant, and an editorial in the journal where it was published called this evidence “compelling”.

Due to a cleverly over-stated press-release, news spread fast, and the study was celebrated worldwide as a major breakthrough in cancer-care. Finally, most commentators felt, research has identified an effective therapy for this debilitating symptom which affects so many of the most desperate patients. Few people seemed to realise that this trial tells us next to nothing about what effects acupuncture really has on cancer-related fatigue.

In order to understand my concern, we need to look at the trial-design a little closer. Imagine you have an amount of money A and your friend owns the same sum plus another amount B. Who has more money? Simple, it is, of course your friend: A+B will always be more than A [unless B is a negative amount]. For the same reason, such “pragmatic” trials will always generate positive results [unless the treatment in question does actual harm]. Treatment as usual plus acupuncture is more than treatment as usual, and the former is therefore moer than likely to produce a better result. This will be true, even if acupuncture is no more than a placebo – after all, a placebo is more than nothing, and the placebo effect will impact on the outcome, particularly if we are dealing with a highly subjective symptom such as fatigue.

I can be fairly confident that this is more than a theory because, some time ago, we analysed all acupuncture studies with such an “A+B versus B” design. Our hypothesis was that none of these trials would generate a negative result. I probably do not need to tell you that our hypothesis was confirmed by the findings of our analysis. Theory and fact are in perfect harmony.

You might say that the above-mentioned acupuncture trial does still provide important information. Its authors certainly think so and firmly conclude that “acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life”. Authors of similarly designed trials will most likely arrive at similar conclusions. But, if they are true, they must be important!

Are they true? Such studies appear to be rigorous – e.g. they are randomised – and thus can fool a lot of people, but they do not allow conclusions about cause and effect; in other words, they fail to show that the therapy in question has led to the observed result.

Acupuncture might be utterly ineffective as a treatment of cancer-related fatigue, and the observed outcome might be due to the extra care, to a placebo-response or to other non-specific effects. And this is much more than a theoretical concern: rolling out acupuncture across all oncology centres at high cost to us all might be entirely the wrong solution. Providing good care and warm sympathy could be much more effective as well as less expensive. Adopting acupuncture on a grand scale would also stop us looking for a treatment that is truly effective beyond a placebo – and that surely would not be in the best interest of the patient.

I have seen far too many of those bogus studies to have much patience left. They do not represent an honest test of anything, simply because we know their result even before the trial has started. They are not science but thinly disguised promotion. They are not just a waste of money, they are dangerous – because they produce misleading results – and they are thus also unethical.

Is acupuncture an effective treatment for pain? This is a question which has attracted decades of debate and controversy. Proponents usually argue that it is supported by good clinical evidence, millennia of tradition and a sound understanding of the mechanisms involved. Sceptics, however, tend to be unimpressed and point out that the clinical evidence of proponents often is cherry-picked, that a long history of usage is fairly meaningless, and that the alleged mechanisms are tentative at best.

This discrepancy of opinions is confusing, particularly for lay people who might be tempted to try acupuncture. But it might vanish in the light of a new, comprehensive and unique evaluation of the clinical evidence.

An international team of acupuncture trialists published a meta-analysed of individual patient data to determine the analgesic effect of acupuncture compared to sham or non-acupuncture control for the following 4 chronic pain conditions: back and neck pain, osteoarthritis, headache, and shoulder pain. Data from 29 RCTs, with an impressive total of 17 922 patients, were included.

The results of this new evaluation suggest that acupuncture is superior to both sham and no-acupuncture controls for each of these conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than those of sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs.

Based on these findings, the authors reached the conclusion that “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”.

Only hours after its publication, this new meta-analysis was celebrated by believers in acupuncture as the strongest evidence yet on the topic currently available. Much of the lay press followed in the same, disappointingly uncritical vein.The authors of the meta-analysis, most of whom are known enthusiasts of acupuncture, seem entirely sure that they have provided the most compelling proof to date for the effectiveness of acupuncture. But are they correct or are they perhaps the victims of their own devotion to this therapy?

Perhaps, a more sceptical view would be helpful – after all, even the enthusiastic authors of this article admit that, when compared to sham, the effect size of real acupuncture is too small to be clinically relevant. Therefore one might argue that this meta-analysis confirms what critics have suggested all along: acupuncture is not a useful treatment for clinical routine.

Unsurprisingly, the authors of the meta-analysis do their very best to play down this aspect. They reason that, for clinical routine, the comparison between acupuncture and non-acupuncture controls is more relevant than the one between acupuncture and sham. But this comparison, of course, includes placebo- and other non-specific effects masquerading as effects of acupuncture – and with this little trick ( which, by the way is very popular in alternative medicine), we can, of course, show that even sugar pills are effective.

I do not doubt that context effects are important in patient care; yet I do doubt that we need a placebo treatment for generating such benefit in our patients. If we administer treatments which are effective beyond placebo with kindness, time, compassion and empathy, our patients will benefit from both specific and non-specific effects. In other words, purely generating non-specific effects with acupuncture is far from optimal and certainly not in the interest of our patients. In my view, it cannot be regarded as not good medicine, and the authors’ conclusion referring to a “reasonable referral option” is more than a little surprising in my view.

Acupuncture-fans might argue that, at the very minimum, the new meta-analysis does demonstrate acupuncture to be statistically significantly better than a placebo. Yet I am not convinced that this notion holds water: the small residual effect-size in the comparison of acupuncture with sham might not be the result of a specific effect of acupuncture; it could be (and most likely is) due to residual bias in the analysed studies.

The meta-analysis is strongly driven by the large German trials which, for good reasons, were heavily and frequently criticised when first published. One of the most important potential drawbacks was that many participating patients were almost certainly de-blinded through the significant media coverage of the study while it was being conducted. Moreover, in none of these trials was the therapist blinded (the often-voiced notion that therapist-blinding is impossible is demonstrably false). Thus it is likely that patient-unblinding and the absence of therapist-blinding importantly influenced the clinical outcome of these trials thus generating false positive findings. As the German studies constitute by far the largest volume of patients in the meta-analysis, any of their flaws would strongly impact on the overall result of the meta-analysis.

So, has this new meta-analysis finally solved the decades-old question about the effectiveness of acupuncture? It might not have solved it, but we have certainly moved closer to a solution, particularly if we employ our faculties of critical thinking. In my view, this meta-analysis is the most compelling evidence yet to demonstrate the ineffectiveness of acupuncture for chronic pain.

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