Acupuncture and Fertility: Misinformation About Acupuncture

Acupuncture and Fertility

Several sensationalist articles have recently been published about acupuncture to report the results of a clinical trial that evaluated the effectiveness of acupuncture in fertility as a complement to in vitro fertilization.

Let us take as an example the conclusion that the journalist from Le Soleil (1) reaches: "Acupuncture doesn't work to get pregnant. It's nothing but a placebo"

According to the authors of the study cited in several forums, such a trial would be relevant because the data regarding complementary acupuncture treatment for women undergoing in vitro fertilization remain controversial. Let us now deconstruct the premise of this publication which arrives at a negative conclusion regarding acupuncture treatment as a complement to IVF at the time of ovarian stimulation and at the time of embryo transfer.

Declared Conflicts of Interest

Among the authors involved, Dr. Chapman reported holding shares in an IVF clinic, while Dr. Norman declared that he also held shares in an IVF company: Fertility SA. For his part, Dr. Johnson declared receiving personal amounts from Guerbet and Vifor Pharma, non-financial support from Bayer Pharma, Merck-Serono, Merck Sharp & Dohme, as well as grants from AbbVie...

The potential profits are therefore present, since IVF protocols are expensive. The global IVF market was valued at around 14 billion as of 2016.

Regardless of the results of this trial, there will be couples who will continue to use acupuncture to promote their fertility. In some cases, these couples will only use acupuncture (2) (3) (without IVF). Others will do nothing at all and wait for nature to take its course.

These are the market sectors that the assisted reproduction industry through IVF needs to convince. Although acupuncture is mentioned as an approach to reduce stress on the Fertility SA clinic website, the mention made of its usefulness for fertility is blunted there.

The Challenge of Achieving a True Control Group⚖

Research in acupuncture poses several challenges, the most important being that of modeling a control group...which will remain, indeed, a control group.

But what is a control group? It is a set of individuals who have not been subjected to the manipulation of a variable, which is the object of the study.

The control group is therefore compared to the experimental group which has undergone the manipulation, in order to determine the effects of this manipulation. The control group is also called the comparison group. It therefore serves as a comparison and is considered inert by definition. This means it cannot be influenced by the variable under study to serve as a comparison.

From the outset, the fact of using a comparison group that does not receive treatment as such is usual for conducting an investigation concerning an intervention—similar to a medication, for which a placebo is used—however, this study model can make participant recruitment difficult and causes those classified in the "waitlist" group to often abandon the study due to loss of interest, which also complicates the interpretation of the results of a study using this particular model.

The fact remains that a control group not receiving acupuncture care was not compared to the "acupuncture" groups in this publication. Instead, they relied on the attempt to create a "placebo" acupuncture: yet, the credibility of the Park tool has been seriously questioned as a placebo.

The placebo used for the control group was therefore probably not inert. Indeed, the authors themselves admit this from the outset in the publication.

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"A recent meta-analysis examining placebo tools as a method of control in acupuncture clinical trials determined that these tools are not necessarily inert controls." -Citation from the publication by Caroline Smith et al.

Let us note in particular that it has been demonstrated that the sham acupuncture used as a control group could activate unmyelinated C-group fibers, which would make these "control groups" active, and therefore insignificant as a comparison for acupuncture applications studying pain with marked affective components.(4)

The study model of the trial in question here used neither a needle as such nor specifically documented acupuncture points. It would therefore be better to compare this control group awkwardly called "sham acupuncture" to a group that received a form of non-specific acupressure.

Now, we know that acupressure (按压 ānmò) would also have been considered comparable to acupuncture for certain applications, notably in the case of dysmenorrhea (5) The Journal of Obstetrics and Gynaecology of Canada actually recommends acupressure in the management of nausea and vomiting in pregnancy, a condition frequently treated with acupuncture, one of the indications for which the WHO has ruled positively on the effectiveness of acupuncture.(6)39814-0/abstract) This further suggests the difficulty encountered by the authors in establishing an adequate control group.

To illustrate the well-documented activity of the "control" group used in acupuncture research, let us note that another trial conducted in 2009 even reported a higher success rate for placebo acupuncture than for real acupuncture. (7) Yet another, conducted in 2010, reported similar data: namely a higher success rate for placebo acupuncture vs real acupuncture, but also a higher success rate for placebo acupuncture vs no acupuncture treatment at all as a complement to a frozen-thawed embryo transfer protocol.

Methodological Weaknesses

Let us return to the methodological weaknesses of the study by Caroline A. Smith et al. in particular, whose results were reported in a pamphleteer style by several daily newspapers.

Although other randomized trials (13)(14) would have allowed positive results to be achieved by applying a minimalist protocol similar to the one tested, the number of acupuncture treatments administered can be considered low and the total follow-up time short...

Some Clinical Considerations

In general, a first acupuncture treatment would have been proposed in the trial protocol between the 6th and 8th day and 2 other treatments were proposed before and after embryo transfer. The majority, namely 65% of women, adhered to the protocol of 3 acupuncture treatments. There would still have been 25% of women receiving only a single acupuncture treatment! As an acupuncturist working in clinical practice full-time for 11 years, I can assure you that a single acupuncture treatment is clinically insignificant as an intervention in the application we are concerned with here.

In normal clinical practice, a more comprehensive treatment plan would have been proposed to patients. To give an idea, I generally propose follow-up over 3 months prior to the IVF protocol, to which are added the 2 sessions pre and post-transfer. This is based on common practices in the matter. Thus, the clinical trial protocol would have consisted of administering, at best, 12.5 to 25% of the "dose" normally recommended, and, at worst, 4.16% to 8.3% of this same normally recommended "dose".(8)

By analogy, would one jump to conclusions after testing the administration of 4 to 25% of the dose of a pharmaceutical product during a clinical study?

To complete a full cycle of circulation in the meridian system, a needle retention time of 27 minutes minimum, to be very precise, would be recommended to respect good clinical practices. The protocol tested in the trial applied a needle retention time of 25 minutes.

Yet, attention to detail is important in clinical practice. Especially since acupuncture treatment targeting fertility addresses biorhythms. The timing of treatments in the cycle matters. The frequency of treatments matters. The duration of treatments matters.

The points chosen would have respected the method of differential diagnosis used in TCM (Traditional Chinese Medicine). This is both a strength and a weakness of the methodology. A strength if the effect of treatment was ultimately specific to specific biostimulation sites, which would indeed be the case for certain applications. However, the different points chosen among different patients add variables that are not controlled in the analysis.

Also, the acupuncturists who administered the acupuncture treatments during the trial would have been admitted following a minimum of 2 years of clinical experience. Were they experts in this specific field of acupuncture care? The authors do not specify.

Let us also note that the stages of embryo transfer were not balanced among the groups under study, the "sham acupuncture" group having been exposed to a greater number of transfers at the blastocyst stage.

Let Us Now Highlight the Strengths of Caroline Smith et al.'s Publication

"The conclusions of our trial are consistent with a recent clinical guideline from the American Society for Reproductive Medicine as well as 2 meta-analyses (15)(16) which demonstrated that acupuncture compared to sham acupuncture administered around the period of ovarian stimulation and transfer does not increase the rate of births during IVF protocols."

One strength of this study is its considerable sample size. 424 women in each of the 2 groups, with good participant retention—824/848—of which 809 could be used for primary analysis. Also, follow-ups were carried out at multiple centers—16 in total across Australia and New Zealand.

The points chosen would have respected the method of differential diagnosis used in TCM (Traditional Chinese Medicine). This reflects an important clinical reality that is often overlooked in acupuncture research protocols since it would often be considered a methodological flaw, as described above. However, the fact of treating patients in the spirit of "customization" more faithfully reflects what actually happens in real acupuncture clinical practice.

The deqi (得气) reaction was sought at the needle in the verum (real acupuncture) group. This presupposes that the acupuncture points were indeed stimulated with an acupuncture needle according to good clinical practices.

Some Additional Reading

Here are 2 clinical trials that led to positive conclusions regarding the use of acupuncture to improve IVF success rates

Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy (13)

Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study (17)

Finally, acupuncture is not a placebo. It is difficult to hold very specific claims at the present time regarding acupuncture support for the IVF protocol. Better research protocols may possibly allow us to return to the positive conclusions initially raised regarding acupuncture integrated into IVF.

We are limited in our ability to study acupuncture using the experimental method. This is also the case for any intervention, which by definition represents an infinite number of uncontrollable variables within the framework of the randomized controlled trial paradigm.

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Acupuncture, Fertility and Perinatality

Acupuncture will continue to play a significant role for many applications in fertility and perinatality, if only as a non-pharmacological solution of choice for stress experienced by women during the IVF process, (9) or as an integrative solution to promote maturation of the cervix, or even back pain and pelvic pain during pregnancy, as well as pain related to childbirth(18), among others...

But let us not forget above all: Male Fertility!

Daily Mail U.K.

We often talk about women when it comes to fertility. However, we know that semen analysis results would be in free fall in North America, Europe, Australia and New Zealand.(10)

The data collected up to 2011 demonstrate that there would have been a 52% decline in sperm concentration and a 59% decrease in total sperm count over a 40-year period.

The good news: clinical trials have demonstrated that acupuncture could in certain cases allow an increase in sperm concentration and motility in men.(11) (12)

Declaration of Conflicts of Interest

Olivier Roy has practiced acupuncture in private practice for 11 years. Acupuncture as a complement to IVF represents a minority part of his practice. Consequently, whether acupuncture as a complement to assisted reproduction continues to be used or not by the population would not change his quality of life.

Montréal, May 2018

REFERENCES

(1) Acupuncture to get pregnant? Jean François Cliche, Le Soleil May 15 2018

(2) Prior to Conception: The Role of an Acupuncture Protocol in Improving Women's Reproductive Functioning Assessed by a Pilot Pragmatic Randomised Controlled Trial. Evid Based Complement Alternat Med. 2016 , Cochrane s et al.

(3) In-Vitro Fertilization (IVF) Market Size, Share & Trends Analysis Report By Instrument (Culture Media, Capital Equipment, IVF Disposable Devices), By Region And Segment Forecasts, 2012 - 2022

(4) Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls? Lund I1, Lundeberg T. Acupunct Med. 2006 Mar;24(1):13-5.

(5) Effects of SP6 acupressure on pain and menstrual distress in young women with dysmenorrhea. Wong CL1, Lai KY, Tse HM. Complement Ther Clin Pract. 2010 May;16(2):64-9. doi: 10.1016/j.ctcp.2009.10.002. Epub 2009 Nov 14.

(6)39814-0/abstract) Management of nausea and vomiting in pregnancy December 2016Volume 38, Issue 12, Pages 1138–1149, Kim Campbell et al.

(7) A randomized double blind comparison of real and placebo acupuncture in IVF treatment. Hum Reprod. 2009 Feb;24(2):341-8. doi: 10.1093/humrep/den380. Epub 2008 Oct 21. So EW et al.

(8) Acupuncture 'dose' (number of treatments) and insurance benefits in the USA, Natalie A Schwehr et al

(9) AJACM, Vol.9, Issue1, 2014 p5-12

(10) Temporal trends in sperm count: a systematic review and meta-regression analysis, Human Reproduction Update*, Volume 23, Issue 6, 1 November 2017, Pages 646–659, Hagai Levine et al,

(11) Success of acupuncture treatment in patients with initially low sperm output is associated with a decrease in scrotal skin temperature. Asian J Androl. 2009 Mar;11(2):200-8. doi: 10.1038/aja.2008.4. Epub 2009 Jan 5. Siterman S et al.

(12) Randomised clinical trial of comparing effects of acupuncture and varicocelectomy on sperm parameters in infertile varicocele patients. Andrologia. 2016 Dec;48(10):1080-1085. doi: 10.1111/and.12541. Epub 2016 Jan 21. Kucuk EV et al.

(13) Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Paulus WE et al. Fertil Steril. 2002 Apr;77(4):721-4.

(14) Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Westergaard LG et al., Fertil Steril. 2006 May;85(5):1341-6. Epub 2006 Apr 5.

(15) The effects of acupuncture on rates of clinical pregnancy among women undergoing in vitro fertilization: a systematic review and meta-analysis. Manheimer E et al. Hum Reprod Update. 2013 Nov-Dec;19(6):696-713

(16) Acupuncture and assisted reproductive technology. Cheong YC et al. Cochrane Database Syst Rev. 2013 Jul 26;(7):CD006920

(17) Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Dieterle S, Fertil Steril. 2006 May;85(5):1347-51. Epub 2006 Apr 17.

(18) The Acupuncture Evidence Project A Comparative Literature Review John McDonald Stephen Janz January 2017, Commissioned by Australian Acupuncture and Chinese Medicine Association Ltd. This important literature review granted the rating of potential positive effect of acupuncture for back pain and pelvic pain during pregnancy, as well as pain related to childbirth.