Trick or Treatment (11 page)

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Authors: Simon Singh,Edzard Ernst M.D.

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Another attempt at placebo acupuncture involved needling at points that are not acupuncture points. Such points traditionally have nothing to do with a patient’s health. This misplaced needling would seem like genuine acupuncture to new patients, but according to the Chinese theory misplaced needling should have no medical benefit because it would miss the meridians. Hence, some trials were planned in which the control group would receive misplaced needling and the treatment group would receive genuine acupuncture. Both groups would receive the benefit of the placebo effect, but any extra improvement in the treatment group could then be attributed to acupuncture.

These two forms of placebo acupuncture, misplaced and superficial, are often termed sham needling. During the 1990s, sceptics pushed for a major reassessment of acupuncture, this time with placebo-controlled clinical trials involving sham needling. For many acupuncturists, such research was redundant because they had seen how their own patients had responded so positively. They argued that the evidence in favour of their treatment was already compelling. When critics continued to demand placebo-controlled trials, the acupuncturists accused them of clutching at straws and of being prejudiced against alternative medicine. Nevertheless, those medical researchers who believed in the authority of the placebo-controlled trial refused to back down. They continued to voice their doubt and argued that acupuncture would remain a dubious therapy until it had proved itself in high-quality clinical trials.

Those demanding proper acupuncture trials eventually had their wish granted when major funding enabled dozens of placebo-controlled clinical trials to take place in Europe and America throughout the 1990s. Each trial was to be conducted rigorously in the hope that the results would shed new light on who was right and who was wrong. Was acupuncture a miracle medicine that could treat everything from colour blindness to whooping cough, or was it nothing more than a placebo?

Acupuncture on trial

 

By the end of the twentieth century a new batch of results began to emerge from the latest clinical trials on acupuncture. In general these trials were of higher quality than earlier trials, and some of them examined the impact of acupuncture on conditions that had not previously been tested. With so much new information, the WHO decided that it would take up the challenge of summarizing all the research and presenting some conclusions.

Of course, the WHO had already published a summary document in 1979, which had been very positive about acupuncture’s ability to treat more than twenty conditions, but they were keen to revisit the situation in light of the new data that was emerging. The WHO team eventually took into consideration the results from 293 research papers and published their conclusions in 2003 in a report entitled
Acupuncture: Review and analysis of reports on controlled clinical trials
. The new report assessed the amount and quality of evidence to support the use of acupuncture for a whole series of conditions, and it summarized its conclusions by dividing diseases and disorders into four categories. The first category contained conditions for which there was the most convincing evidence in favour of using acupuncture and the fourth contained conditions for which the evidence was least convincing:

 
  1. Conditions ‘for which acupuncture has been proven – through controlled trials – to be an effective treatment’ – this included twenty-eight conditions ranging from morning sickness to stroke.
  2.  
  3. Conditions ‘for which the therapeutic effect of acupuncture has been shown but for which further proof is needed’ – this included sixty-three conditions ranging from abdominal pain to whooping cough.
  4.  
  5. Conditions ‘for which there are only individual controlled trials reporting some therapeutic effects, but for which acupuncture is worth trying because treatment by conventional and other therapies is difficult’ – this included nine conditions, such as colour blindness and deafness.
  6.  
  7. Conditions ‘for which acupuncture may be tried provided the practitioner has special modern medical knowledge’ – this included seven conditions, such as convulsions in infants and coma.
  8.  
 

The 2003 WHO report concluded that the benefits of acupuncture were either ‘proven’ or ‘had been shown’ in the treatment of ninety-one conditions. It was mildly positive or equivocal about a further sixteen conditions. And the report did not exclude the use of acupuncture for any conditions. The WHO had given acupuncture a ringing endorsement, reinforcing their 1979 report.

It would be natural to assume that this was the final word in the debate over acupuncture, because the WHO is an international authority on medical issues. It would seem that acupuncture had shown itself to be a powerful medical therapy. In fact, the situation is not so clear cut. Regrettably, as we shall see, the 2003 WHO report was shockingly misleading.

The WHO had made two major errors in the way that it had judged the effectiveness of acupuncture. The first error was that they had taken into consideration the results from too many trials. This seems like a perverse criticism, because it is generally considered good to base a conclusion on lots of results from lots of trials involving lots of patients – the more the merrier. If, however, some of the trials have been badly conducted, then those particular results will be misleading and may distort the conclusion. Hence, the sort of overview that the WHO was trying to gain would have been more reliable had it implemented a certain level of quality control, such as including only the most rigorous acupuncture trials. Instead, the WHO had taken into consideration almost every trial ever conducted, because it had set a relatively low quality threshold. Therefore, the final report was heavily influenced by untrustworthy evidence.

The second error was that the WHO had taken into consideration the results of a large number of acupuncture trials originating from China, whereas it would have been better to have excluded them. At first sight, this rejection of Chinese trials might seem unfair and discriminatory, but there is a great deal of suspicion surrounding acupuncture research in China. For example, let’s look at acupuncture in the treatment of addiction. Results from Western trials of acupuncture include a mixture of mildly positive, equivocal or negative results, with the overall result being negative on balance. By contrast, Chinese trials examining the same intervention always give positive results. This does not make sense, because the efficacy of acupuncture should not depend on whether it is being offered in the Eastern or Western hemisphere. Therefore, either Eastern researchers or Western researchers must be wrong – as it happens, there are good reasons to believe that the problem lies in the East. The crude reason for blaming Chinese researchers for the discrepancy is that their results are simply too good to be true. This criticism has been confirmed by careful statistical analyses of all the Chinese results, which demonstrate beyond all reasonable doubt that Chinese researchers are guilty of so-called
publication bias
.

Before explaining the meaning of publication bias, it is important to stress that this is not necessarily a form of deliberate fraud, because it is easy to conceive of situations when it can occur due to an unconscious pressure to get a particular result. Imagine a Chinese researcher who conducts an acupuncture trial and achieves a positive result. Acupuncture is a major source of prestige for China, so the researcher quickly and proudly publishes his positive result in a journal. He may even be promoted for his work. A year later he conducts a second similar trial, but on this occasion the result is negative, which is obviously disappointing. The key point is that this second piece of research might never be published for a whole range of possible reasons: maybe the researcher does not see it as a priority, or he thinks that nobody will be interested in reading about a negative result, or he persuades himself that this second trial must have been badly conducted, or he feels that this latest result would offend his peers. Whatever the reason, the researcher ends up having published the positive results of the first trial, while leaving the negative results of the second trial buried in a drawer. This is publication bias.

When this sort of phenomenon is multiplied across China, then we have dozens of published positive trials, and dozens of unpublished negative trials. Therefore, when the WHO conducted a review of the published literature that relied heavily on Chinese research its conclusion was bound to be skewed – such a review could never take into account the unpublished negative trials.

The WHO report was not just biased and misleading; it was also dangerous because it was endorsing acupuncture for a whole range of conditions, some of which were serious, such as coronary heart disease. This begs the question, how and why did the WHO write a report that was so irresponsible?

The WHO has an excellent record when it comes to conventional medicine, but in the area of alternative medicine it seems to prioritize political correctness above truth. In other words, criticism of acupuncture might be perceived as criticism of China, of ancient wisdom and of Eastern culture as a whole. Moreover, usually when expert panels are assembled in order to review scientific research, the protocol is to include experts with informed but diverse opinions. And, crucially, the panel should include critical thinkers who question and challenge any assumptions; otherwise the panel’s deliberations are a meaningless waste of time and money. However, the WHO acupuncture panel did not include a single critic of acupuncture. It was quite simply a group of believers who unsurprisingly were less than objective in their assessment. Most worrying of all, the report was drafted and revised by Dr Zhu-Fan Xie, who was Honorary Director of the Institute of Integrated Medicines in Beijing, which fully endorses the use of acupuncture for a range of disorders. It is generally in appropriate for someone with such a strong conflict of interest to be so closely involved in writing a medical review.

If we cannot trust the WHO to summarize adequately the vast number of clinical trials concerning acupuncture, then to whom do we turn? Fortunately, several academics around the world have made up for the WHO’s failure by providing their own summaries of the research. Thanks to these groups, we can at long last answer the question that has lingered throughout this chapter – is acupuncture effective?

The Cochrane Collaboration

 

Doctors are confronted each year with hundreds of new results from clinical trials, which might cover everything from re-testing an existing mainstream treatment to initial testing of a controversial alternative therapy. Often there will be several trials focused on the same treatment for the same ailment, and results can be difficult to interpret and sometimes contradictory. With not enough hours in the day to deal with patients, it would be impractical and nonsensical for doctors to read through each research paper and come to their own conclusions. Instead, they rely heavily on those academics who devote themselves to making sense of all this research, and who publish conclusions that help doctors advise patients about the best form of treatment.

Perhaps the most famous and respected authority in this field is the Cochrane Collaboration, a global network of experts coordinated via its headquarters in Oxford. Firmly adhering to the principles of evidence-based medicine, the Cochrane Collaboration sets itself the goal of examining clinical trials and other medical research in order to offer digestible conclusions about which treatments are genuinely effective for which conditions. Before revealing the Cochrane Collaboration’s findings on acupuncture, we will first briefly look at its origins and how it came to be held in such high regard. In this way, by establishing the Cochrane Collaboration’s reputation, we hope that you will accept their conclusions about acupuncture in due course.

The Cochrane Collaboration is named after Archie Cochrane, a Scotsman who abandoned his medical studies at University College Hospital, London, in 1936 to serve in the Spanish Civil War as part of a Field Ambulance Unit. Then in the Second World War h e joined the Royal Army Medical Corps as a captain and served in Egypt, but he was captured in 1941 and spent the rest of the war providing medical help to fellow prisoners. This was when he first became aware of the importance of evidence-based medicine. He later wrote that the prison authorities would encourage him by claiming that he was at liberty to decide how to treat his patients: ‘I had con siderable freedom of choice of therapy: my trouble was that I did not know which to use and when. I would gladly have sacrificed my freedom for a little knowledge.’ In order to arm himself with more know ledge he conducted his own trials among his fellow prisoners – he earned their support by telling them about James Lind and the role of clinical trials in working out the best treatment for patients with scurvy.

Whilst Cochrane was clearly a fervent advocate of the scientific method and clinical trials, it is important to note that he also realized the medical value of human compassion, as demonstrated by numerous events throughout his life. One of the most poignant examples occurred during his time as a prisoner of war at Elsterhorst, Germany, when he found himself in the hopeless position of treating a Soviet prisoner who was ‘moribund and screaming’. All Cochrane could offer was aspirin. As he later recalled:

I finally instinctively sat down on the bed and took him in my arms, and the screaming stopped almost at once. He died peacefully in my arms a few hours later. It was not the pleurisy that caused the screaming but loneliness. It was a wonderful education about the care of the dying.

 

After the war, Cochrane went on to have a distinguished career in medical research. This included studying pneumoconiosis in the coal miners of South Wales and becoming Professor of Tuberculosis and Chest Diseases at the Welsh National School of Medicine in 1960. As his career progressed, he became even more passionate about the value of evidence-based medicine and the need to inform doctors about the most effective medicines. At the same time, he realized that doctors struggled to make sense of all the results from all the clinical trials that were being conducted around the world. Hence Cochrane argued that medical progress would be best served if an organization could be established with the responsibility of drawing clear-cut conclusions from the myriad research projects. In 1979 he wrote, ‘It is surely a great criticism of our profession that we have not organised a critical summary, by speciality or subspeciality, adapted periodically, of all relevant randomised controlled trials.’

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