Trick or Treatment (12 page)

The key phrase in Cochrane’s statement was ‘a critical summary’, which implied that whoever was doing the summary ought to assess critically the value of each trial in order to determine to what extent it should contribute to the final conclusion about whether a particular therapy is effective for a particular condition. In other words, a carefully conducted trial with lots of patients should be taken seriously; a less carefully conducted trial with just a few patients should carry less weight; and a poorly conducted trial should be ignored completely. This type of approach would become known as a
systematic review
. It is a rigorous scientific evaluation of the clinical trials relating to a particular treatment, as opposed to the sort of reports that the WHO was publishing on acupuncture, which were little more than casual uncritical overviews.

An evidence-based approach to medicine, as previously discussed, means looking at the scientific evidence from clinical trials and other sources in order to decide best medical practice. The systematic review is often the final stage of evidence-based medicine, whereby a conclusion is drawn from all the available evidence. Archie Cochrane died in 1988, by which time the ideas of evidence-based medicine and systematic reviews had taken hold in medicine, but it was not until 1993 that his vision was fully realized with the establishment of the Cochrane Collaboration. Today it consists of twelve centres around the world and over 10,000 health expert volunteers from over ninety countries, who trawl through clinical trials in order ‘to help people make well-informed decisions by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of interventions in all areas of health care’.

Having been in existence for over a decade, the Cochrane Collaboration has by now accumulated a library consisting of the results of thousands of trials and has published hundreds of systematic reviews. As well as providing judgements on the effectiveness of pharmaceutical drugs, these systematic reviews evaluate all sorts of other treatments, as well as preventative measures, the value of screening, and the impact of lifestyle and diet on health. In each case, the wholly independent Cochrane Collaboration presents its conclusions about the effectiveness of whatever is being systematically reviewed.

Hopefully this background to the Cochrane Collaboration has helped to convey its reputation for independence, rigour and quality. This means that we can now look at their systematic reviews of acupuncture and can confidently assume that their conclusions are very likely to be accurate. The Cochrane Collaboration has published several systematic reviews relating to the impact of acupuncture on a variety of conditions, focusing largely on the evidence from placebo-controlled clinical trials.

First, here is the bad news for acupuncturists. The Cochrane reviews suggest that there is no significant evidence to show that acupuncture is an effective treatment for any of the following conditions: smoking addiction, cocaine dependence, induction of labour, Bell’s palsy, chronic asthma, stroke rehabilitation, breech presentation, depression, epilepsy, carpal tunnel syndrome, irritable bowel syndrome, schizophrenia, rheumatoid arthritis, insomnia, non-specific back pain, lateral elbow pain, shoulder pain, soft tissue shoulder injury, morning sickness, egg collection, glaucoma, vascular dementia, period pains, whiplash injury and acute stroke. Having examined scores of clinical trials, the Cochrane reviews conclude that any perceived benefit from acupuncture for these conditions is merely a placebo effect. The summaries contain the following sorts of conclusions:

Also, the Cochrane reviews regularly criticize the quality of the research conducted to date, with comments such as: ‘The quality of the included trials was inadequate to allow any conclusion.’ Whether the trials were reliable or unreliable, the upshot is the same: despite thousands of years of use in China and decades of scientific research from many countries, there is no sound evidence to support the use of acupuncture for any of the disorders named above.

This is particularly worrying in light of the sort of treatments currently being offered by many acupuncture clinics. For example, by searching for a UK acupuncturist on the web and clicking on the first advert, it was simple to find a central London clinic offering acupuncture for the treatment of all of the following conditions: addictions, anxiety, circulatory problems, depression, diabetes, facial rejuvenation, fatigue, gastrointestinal problems, hay fever, heart problems, high blood pressure, six categories of infertility, insomnia, kidney disorders, liver disease, menopausal problems, menstrual problems, pregnancy care, birth induction, morning sickness, breech presentation, respiratory conditions, rheumatism, sexual problems, sinus problems, skin problems, stress-related illness, urinary problems and weight loss. These conditions fall into one of three categories:

1. Cochrane reviews deem that the evidence from clinical trials does not show acupuncture to be effective.
   
 

2. Cochrane reviews conclude that the clinical trials have been so poorly conducted that nothing can be said about the effectiveness of acupuncture with any confidence.
   
 

3. The research is so poor and so minimal that the Cochrane Collaboration has not even bothered conducting a systematic review.
   
 

Moreover, systematic reviews by other institutions and universities come to exactly the same sort of conclusions arrived at by the Cochrane Collaboration. Despite the fact that there is no reason to believe that it works for any of these conditions, except as a placebo, thousands of clinics in Europe and America are still willing to promote acupuncture for such a wide-ranging list of ailments.

The good news for acupuncturists is that the Cochrane reviews have been more positive about acupuncture’s ability to treat other conditions. There have been cautiously optimistic Cochrane reviews on the treatment of pelvic and back pain during pregnancy, low back pain, headaches, post-operative nausea and vomiting, chemotherapy-induced nausea and vomiting, neck disorders and bedwetting. Aside from bedwetting, the only positive conclusions relate to acupuncture in dealing with some types of pain and nausea.

Although these particular Cochrane reviews are the most positive about acupuncture’s benefits, it is important to note that their support is only half-hearted. For example, in the case of idiopathic headaches, namely those that occur for no known reason, the review states: ‘Overall, the existing evidence supports the value of acupuncture for the treatment of idiopathic headaches. However, the quality and amount of evidence are not fully convincing.’

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.