RCT of real versus placebo acupuncture in IVF

Sir, In 1993, the World Health Organization (WHO) published a booklet on the Standard Acupuncture Nomenclature after a WHO-consensus meeting in the Philippines (WHO, 1993). Needless to say that this publication, which was not at all peer reviewed, did not contain any reference to anatomic structures as we know them from the anatomic theatre or from our operation theatres. To the ‘acupoints’ mentioned in this book, like LR3, SP8, GV20 and so on, there is no anatomical correlate and actually they do not exist. To enlarge the confusion and add insult to injury, Chinese acupuncturists diagnose conditions as: ‘Kidney/Yang Yin deficiency’, ‘Liver Q stagnation’ and ‘Spleen Qi deficiency with Phlegm’. Since the 1993 WHO-publication things have even become worse in this political body, numerically dominated by Third World countries, as in 2003 they published a report ‘Acupuncture: Review and Analysis of Reports on Controlled Clinical Trials’, which contained a list of diseases, symptoms or conditions for which acupuncture had been ‘proved’— through controlled trials—to be an effective treatment (WHO, 2003). These indications included adverse reactions to radiotherapy and/or chemotherapy, allergic rhinitis, biliary colic, acute bacillary dysentery, rheumatoid arthritis, tennis elbow and many others. For a number of gynaecological conditions acupuncture ‘could be tried’, but further proof was awaited. IVF was not mentioned in that list. When reading in the paper of So et al. (2009) that ‘SP6 is the crossing point of the kidney, the spleen and the liver channels, considered to play a crucial role in treating female infertility’ I thought that I was reading another disgraceful WHO-publication, but this did not happen to be the case: I was indeed reading a paper in an electronic version of the October 2008 issue of our peer reviewed and reputable Human Reproduction! For unknown reasons, Chinese acupuncture is by its admirers considered as helpful in IVF, while they are unable to offer any plausible explanation for its action and although meta-analyses of RCTs—of which there are quite a few by now—are still somewhat contradictory. With the late Skranabek who once stated that ‘Extraordinary claims require extraordinary evidence, and randomized clinical trials, applied to absurd claims, are more likely to mislead than illuminate’ (Skranabek, 1990), we do not think that the RCT has been developed to test absurd claims. Unless there is a priori doubt about the outcome, any RCT is superfluous and even ethically dubious, which is therefore the case in trials of acupuncture. Chinese acupuncture is an atavism based on a pre-Vesalian ‘theory’ that is completely irreconcilable with our present biomedical science and the suggestions done by So et al. as to why the effects of ‘real acupuncture’ and ‘placebo acupuncture’ in their RCT hardly differ, with the exception of one of their seven outcome parameters, are far-fetched and superfluous. They have obviously compared two types of placebo therapies! So et al. performed a well-designed trial, for which they are to be commended, and their publication might well be one of the very few negative RCTs on acupuncture from the Chinese republic, which is encouraging. Vickers et al. (1998) could not find one single negative RCT on acupuncture from China, while trials done in the UK or the USA gave an average of 50–60% positive outcomes. Both figures point to the methodological weaknesses of many trials in acupuncture as was already discovered by ter Riet et al. (1989), who noticed that how the better the methodology is, the less chance there is of a positive result. They stated to expect that a perfect trial would most likely not show any effect above the placebo-effect. These early observations of ter Riet et al. were recently confirmed by biostatistician Barker Bausell (2007), who worked for some years in the CAM-research as it is stimulated and paid for by the National Center for Complementary and Alternative Medicine, Bethesda, USA. He came—after starting his job with an open mind—to the conclusion that ‘CAM therapies are nothing more than cleverly packed placebos’ and wrote a very nice book about his experience with CAM-trials and more especially acupuncture-trials. I think that medical journals should not publish papers on absurd forms of treatment and hope that Human Reproduction stops to surprise its readers with publications in which—quotes from So’s paper—treatments are tested that are supposed to ‘strengthen the essence of kidney and liver and adjust Qi and blood perfusion of the uterus’.