President of Italian acupuncture body casts doubt on validity of IVF study

Carlo Maria Giovanardi, MD

Carlo Maria Giovanardi, MD

The president of the Italian Federation of Acupuncture Societies (F.I.S.A) has questioned the validity of a recent study which suggested that acupuncture did not improve the rate of live births among women undergoing IVF.

The study, Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization by Caroline A. Smith et al., was published in the Journal of the Americal Medical Association (JAMA) in May.

In a letter to the journal's editor, Carlo Maria Giovanardi, MD, has branded the research 'invalid' due to the lack of a 'true control group'.

He claims that sham acupuncture, which the researchers used as a control to compare with traditional acupuncture, is not 'an inert placebo', as the study suggests, but, on the contrary, could itself have a positive impact on pregnancy rates.

This, he postulates, has served to 'unnecessarily confuse rather than clarify the interpretation of the effects of IVF adjuvant acupuncture.'

He concludes that more positive effects from using acupuncture in IVF could have been expected if an appropriate control and more reasonable acupuncture programs had been used.

Following the publication of the study in May, the British Acupuncture Society (BAcC) issued an official response, saying the findings were misleading because women undergoing IVF had not received the recommended number of acupuncture treatments.

Acupuncturists from around the world have pointed to research which suggests traditional acupuncture combined with other Chinese medicine treatment modalities and lifestyle advice (Whole Systems TCM) does have an impact on pregnancy and live birth rates in IVF patients and have called for more research to be carried out.

Dr Carlo Maria Giovanardi's letter in full:

Dear Editor and corresponding Author

What scientific contribution when methodology has so many limitations?

I have thoroughly read the article Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization by Caroline A. Smith et al. published by JAMA in May 2018, and would like to make some observations.

The authors themselves identify five limitations to their study; however, in spite of them, they reach a definite and clearly stated conclusion (‘These findings do not support the use of acupuncture when administered at the time of ovarian stimulation and embryo transfer to improve the rate of live births’) which leaves no doubt as to the total inefficacy of acupuncture to improve birth outcomes among women undergoing IVF. Such a strong statement, therefore, is supported by a trial, limitations of which have been identified but not overcome.

I am sure, we all agree on one point, namely that a methodologically incorrect article brings about misleading results which affect the choices of both medical doctors and patients; that’s why I wonder how the conclusions reached can be useful to acupuncturists and patients who decide to choose acupuncture as a therapy.

However, this is not the main issue I’d like to focus on.

My analysis starts with the generally accepted principle that no skin stimulation is inert, which implies that ‘sham acupuncture’ cannot be inert: any skin stimulation brings about central and peripheral responses (Birch S., A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert, J Altern Complement Med, 2006). Effects have been observed when using non-needle sham, penetrating sham needles and non-penetrating sham needles, although they were different in size (MacPherson H., Influence of control group on effect size in trials of acupuncture for chronic pain: a secondary analysis of an individual patient data meta-analysis, PLos One, 2014).

The authors say that sham acupuncture can lead to weak physiological effects and the sham needle has been shown to stimulate different brain activity than acupuncture: this means, they recognize and accept the fact that sham treatment is not inert.

At the same time, their study addressed whether acupuncture was more efficacious than a placebo. This appears to be a contradiction in terms: how can sham acupuncture be defined as a placebo treatment? Placebo means being inert, by definition, whereas sham is not, according both to the literature and to the article. Effects may be minimal, as researchers assume, but as a matter of fact such outcomes cannot be assessed, and therefore any speculation is possible.

Moreover, the authors affirm that they used sham points at locations away from known acupuncture points and with no known function, to minimize physiological effects.

First, if they decide to ‘minimize’ the effects, they admit that the effects are not only present but also remarkable and – let me repeat it –their impact cannot be assessed. Second, according to the Traditional Chinese Medicine, there are no points with no function, the whole skin being able to trigger physiological responses, as it is clearly revealed by the functions of the cutaneous regions called pí  bù in Chinese (Maciocia G., The foundations of Chinese medicine: a comprehensive text for acupuncturists and herbalists, 1989; Ching N., The fundamentals of acupuncture, 2016).

By proceeding this way, a cutaneous stimulation, such as acupuncture, has been compared with another manual therapy involving skin stimulation and with widely recognized neuroendocrine effects; moreover, sham being a manual technique, various different effects may be associated with its administration.

Minimal, superficial, sham, or 'placebo' acupuncture have been thoroughly investigated:  it has been demonstrated that light touch of the skin stimulates mechanoreceptors coupled to slow conducting unmyelinated (C) afferents resulting in activity in the insular region, but not in the somatosensory cortex. Activity in these C tactile afferents has been suggested to induce a 'limbic touch' response resulting in emotional and hormonal reactions. It is likely that, in many acupuncture studies, control procedures that are meant to be inert are in fact activating these C tactile afferents. (Lund I., Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls?, Acupunct Med, 2006).

Because of the risk – might we say certainty? - that the sham is not an inert placebo but rather an active treatment that may affect the pregnancy outcome, using sham acupuncture as the control may unnecessarily confuse rather than clarify the interpretation of the effects of IVF adjuvant acupuncture (Manheimer E., Selecting a control in IVF and acupuncture RCTs: how sham controls may unnecessarily complicate the RCT evidence base, Fertil Steril, 2011).

Sham acupuncture may introduce bias against the treatment being tested and I share Lund’s point of view when she affirms that minimal acupuncture is not valid as an inert placebo-control despite its conceptual brilliance (Lund I., Minimal acupuncture is not a valid placebo control in randomised controlled trials of acupuncture: a physiologist’s perspective, Chin Med, 2009).

In conclusion, an important risk of bias exists in this study and what it actually lacks is a true control group (a care alone group). As already suggested by Zheng (Zheng C.H., Effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization: a systematic review and meta-analysis, Fertil Steril, 2012), sham acupuncture (Streitberger control) may not be an inactive control. More positive effects from using acupuncture in IVF can be expected if an appropriate control and more reasonable acupuncture programs are used.

I do hope, my contribution can lead to a fruitful debate providing useful insight into CAM therapies; I appreciate your attention to this important matter and remain at your disposal for any comments you may have.

Very truly yours,

Carlo Maria Giovanardi, MD

President of the Italian Federation of Acupuncture Societies (F.I.S.A.)

 

Notes to Editor:

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The British Acupuncture Council (BAcC) has a membership of nearly 3,000 professionally qualified acupuncturists. It is the UK's largest professional body for the practice of acupuncture. BAcC members practise a traditional, holistic style of acupuncture diagnosis and treatment based on a system developed and refined over 2,000 years. To achieve BAcC membership, practitioners must first undertake extensive training in traditional acupuncture (minimum three years full-time or part-time equivalent), which includes physiology, anatomy and other biomedical sciences appropriate to the practice of acupuncture.

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Traditional acupuncture as practised by members of the BAcC is based on Chinese medicine principles that have been developed, researched and refined for over 2,500 years. Traditional acupuncture is holistic, not focused on isolated symptoms. It regards pain and illness, whether physical or mental, to be a sign the whole body is out of balance. Western or medical acupuncture is a more recent development practised predominantly by doctors and physiotherapists, who use acupuncture techniques within their existing scope of practice on the basis of a western medical diagnosis

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