Because the evidence is only marginally positive and not fully convincing, even in the areas of pain and nausea, researchers have focused their efforts on improving the quality and amount of evidence in order to reach a more concrete conclusion. Indeed, one of the authors of this book, Professor Edzard Ernst, has been part of this effort. Ernst, who leads the Complementary Medicine Research Group at the University of Exeter, became interested in acupuncture when he learned about it at medical school. Since then, he has visited acupuncturists in China, conducted ten of his own clinical trials, published more than forty reviews examining other acupuncture trials, written a book on the subject and currently sits on the editorial board of several acupuncture journals. This demonstrates his commitment to investigating with an open mind the value of this form of treatment, while thinking critically and helping to improve the quality of acupuncture trials.
One of Ernst’s most important contributions to improving the quality of trials has been to develop a superior form of sham acupuncture, something even better than misplaced or superficial needling. Figure 1 on page 45 shows how an acupuncture device consists of a very fine needle and a broader upper part that is held by the acupuncturist. Ernst and his colleagues proposed the idea of a telescopic needle–that is, an acupuncture needle that looks as if it penetrates the skin, but which instead retracts into the upper handle part, rather like a theatrical dagger.
Jongbae Park, a Korean PhD student in Ernst’s group, went ahead and built a prototype, overcoming various problems along the way. For example, usually an acupuncture needle stays in place because it is embedded in the skin, but the telescopic needle would only appear to penetrate the skin, so how would it stay upright? The solution was to rely on the plastic guide tube, which acupuncturists often use to help position and ease needle insertion. The guide tube is usually removed after insertion, but Park suggested making one end of the tube sticky and leaving it in place so that it could support the needle. Park also designed the telescopic system so that the needle offered some resistance as it retracted into the upper handle. This meant that it would cause some minor sensation during its apparent insertion, which in turn would help convince the patient that this was real acupuncture that was being practised.
When the Exeter group tested these telescopic needles as part of a placebo acupuncture session, patients were indeed convinced that they were receiving real treatment. They saw the long needle, watched it shorten on impact with the skin, felt a small, localized pain and saw the needle sitting in place for several minutes before being withdrawn. Superficial and misplaced needling were adequate placebos, but an ideal acupuncture placebo should not pierce the skin, which is why this telescopic needling was a superior form of sham therapy. The team was delighted to have developed and validated the first true placebo for acupuncture trials, though their pride was tempered when they discovered that two German research groups at Heidelberg and Hannover Universities had been working on a very similar idea. Great minds were thinking alike.
It has taken several years to design, develop and test the telescopic needle, and it has taken several more years to arrange and conduct clinical trials using it. Now, however, the first results have begun to emerge from what are arguably the highest‑quality acupuncture trials ever conducted.
These initial conclusions have generally been dis appointing for acupuncturists: they provide no convincing evidence that real acupuncture is significantly more effective than placebo acupuncture in the treatment of chronic tension headache, nausea after chemotherapy, post‑operative nausea and migraine prevention. In other words, these latest results contradict some of the more positive conclusions from Cochrane reviews. If these results are repeated in other trials, then it is probable that the Cochrane Collaboration will revise its conclusions and make them less positive. In a way, this is not so surprising. In the past, when trials were poorly conducted, the results for acupuncture seemed positive; but when the trials improved in quality, then the impact of acupuncture seemed to fade away. The more that researchers eliminate bias from their trials, the greater the tendency for results to indicate that acupuncture is little more than a placebo. If researchers were able to conduct perfect trials, and if this trend continues, then it seems likely that the truth is that acupuncture offers negligible benefit.
Unfortunately, it will never be possible to conduct a perfect acupuncture trial, because the ideal trial is double‑blind, meaning that neither the patient nor the practitioner knows if real or placebo treatment is being given. In an acupuncture trial, the practitioner will always know if the treatment is real or a placebo. This might seem un important, but there is a risk that the practitioner will unconsciously communicate to the patient that a placebo is being administered, perhaps because of the practitioner’s body language or tone of voice. It could be that the marginally positive results for acupuncture for pain relief and nausea apparent in some trials are merely due to the slight remaining biases that occur with single blinding. The only hope for minimizing this problem in future is to give clear and strong guidance to practitioners involved in trials to minimize inadvertent communication.
While some scientists have focused on the use of telescopic needles in their trials, German researchers have concentrated on involving larger numbers of patients in order to improve the accuracy of their con clusions. German interest in testing acupuncture dates back to the late 1990s, when the national authorities voiced serious doubts about the entire field. They questioned whether they should continue paying for acupuncture treatment in the light of the lack of reliable evidence. To remedy the situation, Germany’s Federal Committee of Physicians and Health Insurers took a dramatic step and decided to initiate eight high‑quality acupuncture trials, which would examine four ailments: migraine, tension‑type headache, chronic low back pain and knee osteoarthritis. These trials were to involve more patients than any previous acupuncture trial, which is why they became known as mega‑trials.
The number of patients in the trials ranged from 200 to over 1,000. Each trial divided its patients into three groups: the first group received no acupuncture, the second group received real acupuncture, and the third (placebo) group received sham acupuncture. In terms of sham acupuncture, the researchers did not employ the new stage‑dagger needles, as they had only just been invented and had not yet been properly assessed. Instead, sham acupuncture took the form of misplaced or superficial needling Due to their sheer size, these mega‑trials have taken many years to conduct. They were completed only recently and the emerging data is still being analysed. Nevertheless, by 2007 the researchers published their initial conclusions from all the mega‑trials. They indicate that real acupuncture performs only marginally better than or the same as sham acupuncture. The conclusions typically contain the following sort of statement: ‘Acupuncture was no more effective than sham acupuncture in reducing migraine headaches.’ Again, the trend continues–as the trials become increasingly rigorous and more reliable, acupuncture increasingly looks as if it is nothing more than a placebo.
Conclusions