MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Does acupuncture increase birth rates after IVF?

You might be correct when pointing out that this is a rhetorical question.

Why should acupuncture increase the live birth rates after in vitro fertilization (IVF)?

Because it re-balances yin and yang?

Give me a break!!!

Yet acupuncture is widely used by women undergoing IVF, and therefore, we perhaps ought to know whether it works.

Laudably someone has conducted a trial so that we know the answer.

This study determined the efficacy of acupuncture compared with a sham acupuncture control performed during IVF on live births. It was designed as a single-blind, parallel-group RCT, including 848 women undergoing a fresh IVF cycle, and conducted at 16 IVF centres in Australia and New Zealand between June 29, 2011, and October 23, 2015, with 10 months of pregnancy follow-up until August 2016.

The women received either acupuncture (n = 424) or a sham acupuncture control (n = 424). The first treatment was administered between days 6 to 8 of follicle stimulation, and two treatments were administered prior to and following embryo transfer. The sham control used a non-invasive needle placed away from acupuncture points. The primary outcome was live birth, defined as the delivery of one or more living infants at greater than 20 weeks’ gestation or birth weight of at least 400 g.

Among the 848 women, 24 withdrew consent, and 824 were included in the study, 607 proceeded to an embryo transfer, and 809 (98.2%) had data available on live birth outcomes. Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control.

The authors concluded that among women undergoing IVF, administration of acupuncture vs sham acupuncture at the time of ovarian stimulation and embryo transfer resulted in no significant difference in live birth rates. These findings do not support the use of acupuncture to improve the rate of live births among women undergoing IVF.

This is a clear result and technically a fairly decent study. I say ‘fairly decent’ because, had the result been positive, one would have to question the efficacy blinding as well as the fact that the acupuncturists might have (inadvertently?) influenced their verum-patients such that they were less anxious and thus produced better outcomes. Moreover, the trial was under-powered, and its publication so long after the end of the study is odd, in my view.

There have, of course, been plenty of trials and even systematic reviews of this topic. Here are the conclusions of the three most recent reviews:

Yet the authors state that “the evidence for efficacy is conflicting”.

Why?

The above conclusions seem crystal clear and not at all conflicting!

Is it because the authors needed to justify the no doubt huge costs for their study?

Is it because conducting such a trial while the evidence is already clear (and negative) is arguably not ethical?

Is it because the authors needed this alleged ‘uncertainty’ for getting their trial in a major journal?

I am, of course, not sure – but I am quite sure of one thing: the evidence that acupuncture is useless for IVF was already pretty clear when they started their study.

And pretending otherwise amounts to telling porkies, doesn’t it?

And telling porkies is unethical, isn’t it?

35 Responses to Does acupuncture increase birth rates after IVF? No, of course not! But telling a few porkies might help all the same

  • ‘Is it because the authors needed to justify the no doubt huge costs for their study?” Most likely, when the funding for this study $630 000 became publicly known one journalist called it ‘Universities in a wacky waste of cash’

    https://www.dailytelegraph.com.au/news/nsw/universities-in-wacky-waste-of-cash/news-story/277e86c899ce49235489e14ccc6bf520

    What is interesting though is that when they reported these results in ‘The Conversation’ they included gems like this;

    -“This means the study does not support that acupuncture can improve pregnancy or live birth rates for women undergoing IVF. However, in clinical practice, acupuncture may include more sessions prior to an IVF cycle starting. Whether this would make a difference hasn’t been tested.”

    “Studies on a stronger form of acupuncture, electro-acupuncture, found it may influence central sympathetic nerve activity, and may increase blood flow in parts of the body, including improved blood flow and oxygenation to ovarian and uterine tissue.”

    “In our earlier research, acupuncture was shown to reduce the emotional stress and burden experienced by women during IVF treatment. We hope the new findings will enable women and practitioners to make evidence-formed decisions about the use of acupuncture to achieve a pregnancy and live birth. But unpublished findings from our trial highlight a supportive role from acupuncture with reducing stress, increased relaxation and improving how women feel about themselves while undergoing the demands of IVF treatments. These findings suggest while it probably won’t improve a woman’s chance of having a baby, acupuncture could help women deal with the emotional turmoil of IVF.”

    https://theconversation.com/acupuncture-during-ivf-doesnt-increase-chances-of-having-a-baby-96459

    I’ve read somewhere that they are also preparing a separate manuscript on the ‘cost effectiveness’ of acupuncture and IVF – not sure how they will play it.

  • Very interesting.

    From IVF Australia’s website I see that women between the age of 30-34.9 have a live birth rate of just over 35% while for women between 35-39.9 it is just over 25%. The median age in this trial is 35.5. So, yes it might actually be on the low side, and also maybe the reason why this important aspect was not really touched on in the paper?

    Imagine that. ‘Acupuncture decreases your chance of IVF success.’

    https://www.ivf.com.au/ivf-success-rates

  • The paper gives the trial registration with the Australian New Zealand Clinical Trials Registry.

    I can’t see the history of changes (it’s not working for me), but something is odd. The text under Comparator / control treatment states:

    Study group 2: The sham acupuncture group will use the Park Sham device which has a guide tube making it impossible for the subject to see whether the needle has penetrated the skin or not. The sham needle its self is able to slide into the handle, which increases the appearance that the skin has been penetrated. Needle penetration does not occur. The sham needle will be placed away from acupuncture points. The sham acupuncture device is an effective masking device for blinding in randomised controlled trials of acupuncture. Treatment will be administered on day 6-8 and twice on the day of an embryo trasnfer. Study Group 3: Standard care. Standard care involves use of the usual pharmacological and surgical protocols used during the IVF cycle. This is a non randomised arm and women will contribute data only. The trial co-ordinator will make contact with subjects at the assessment time.

    I can find no mention of this Study Group 3 in the paper.

    Surely this is, at best, incompetent or, at worst, fraudulent?

  • They published their trial design in the journal Trials. Not completely sure if I understand their rationale.

    “We will conduct a parallel randomized controlled trial of acupuncture compared with a placebo control using a non-invasive placebo needle. A non-randomized group will receive standard care to allow comparisons with the baseline pregnancy rate. The rationale for a non-randomized arm includes the need to provide a baseline pregnancy rate, and acknowledgement from our previous research experience that women would not accept randomization to this group [17]. We acknowledge this group of women may have different outcomes, and incorporating a usual care group to provide baseline pregnancy rate is problematic. The analysis of the usual care only group will be treated as an observational study with known confounding factors adjusted for in the analysis. The study will recruit participants from IVF centers in Australia (IVF Australia, Assisted Conception and Fertility South Australia, Flinders Reproductive) and one center in New Zealand (Fertility Plus).”

    https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-60

    • but why not report the results of this 3rd group in the paper?

      • That’s a good question.
        I can understand that this 3rd group is a bit more difficult because you are promising women IVF plus some magic which might improve their chances, and for the 3rd group only standard stuff without magic, hence I as a desperate person would not like to be randomised into group 3 -some people get some added stuff and I don’t. Or at least that is what I think.

        This is now from the participants perspective. From the researchers one would at the very least expect some sort of discussion on why this data was not included even though it was part of the initial trial design – this is the missing link, you need some sort of baseline comparison. For argument sake; let’s say they did include this group and both acupuncture plus sham showed improved outcomes then they would have had something to sell, and I think the title of the paper might have been completely different.

        But now they have excluded this data, and that makes me a bit suspicious – I smell a acupuncturist!

        • Being randomised to usual care alone is likely produce a negative patient response given the widespread high regard for acupuncture amongst the prenatal population and many professionals.

          A segregated (non-randomised) usual care group might eliminate or reduce a negative bias due to randomisation. Parity between the results of three groups would suggest acupuncture is ineffective and the sham worked well.

          That acupuncture and sham acupuncture would both lead to fewer pregnancies compared with usual care alone would seem to be as unlikely an outcome as more pregnancies.

          Any other result than parity between the three groups for any other reason than bias is difficult to conceive.

          But what of the usual care group? Enquiring minds would like to know.

          • Obviously only the authors can provide adequate answers. But I’ve looked at the websites of the NHS, IVF Australia and ReproMed (we took part in this clinical trial) and they all give me success rates for usual care alone far higher than reported in this paper. With acupuncture I would expect a placebo effect bordering on significance as compared to usual care, with no difference between acupuncture and sham.

            And yet this important info was omitted and to me it actually look like we might have nocebo effect – can this be possible?

          • That is what one would expect with a group randomised to usual care and effective blinding between the acupuncture and sham groups. More information is required regarding the usual care group, for sure.

          • How would you design such a study.
            Lets say the Aus government asks you to determine the efficacy of acupuncture for infertility? I would say the original design incl the usual care group is a good design. But I would incl a 4th group, acpuncture alone, even though it might be unethical. Infertility is a very sensitive issue.

            I sometimes think that these people do not always understand the implications of their work especially when they omit very important info. But I do think it’s worth a much more thorough investigation.

          • Perhaps a systematic review and meta-analysis by Eric Manheimer et al. is of relevance:

            “We found no pooled benefit of adjuvant acupuncture for IVF. The subgroup finding of a benefit in trials with lower, but not higher, baseline pregnancy rates (the only statistically significant subgroup finding in our earlier review) has been confirmed in this update…”

            https://academic.oup.com/humupd/article/19/6/696/839204

            Perhaps not. Clarification is needed.

          • Another thing. The authors cast doubt on their own enterprise by casting doubt on the validity of sham acupuncture.

            Would they have made the same point if acupuncture had been associated with increased numbers of pregnancies? If not they would be guilty of double standards. If it is true that the sham may not be a sham, it has to be true in both cases.

            But how can acupuncture be significantly different to acupuncture? The choice is between absurdity and naked bias.

            If sham acupuncture may or may not be sham acupuncture the study is pointless. A waste of time and money.

            In this study a non-penetrating needle was positioned at non-acupuncture points. If that’s not sham acupuncture then what is? If there’s no sham acupuncture then acupuncture is beyond falsification. That’s not at all good for the credibility of acupuncture research.

  • Maybe I should contact the authors, and cc the journal, and ask them the following;
    1. Why did it take so long to publish the results?
    2. There is a consensus that a trial of this nature would be far more expensive than $630k – was there a lot of in-kind support or was there other funding sources?
    3. The reported live birth success rate of around 18% seems a bit low when compared with the success rate of IVF alone. If true does this mean acupuncture reduce your chances of a success?
    4. The trial registry and the publication published in Trials mention a group 3, normal IVF treatment alone, as a baseline comparison. This was not mentioned nor discussed in the publication – can you please elaborate on this.
    5. ??

  • And the plot thickens! (shouldn’t they be aware of this kind of report?)

    “Alternative therapies ‘cut IVF fertility rates'”

    https://www.telegraph.co.uk/news/uknews/1556454/Alternative-therapies-cut-IVF-fertility-rates.html

  • The original title of this project (on the trial registry) was “Acupuncture compared to sham acupuncture and standard care to improve live birth rates for women undergoing IVF: a randomised controlled trial” So clearly it had three arms.

    There is a number of possible outcomes:
    -Acupuncture works better/worse/equivalent to sham acupuncture
    -Acupuncture and/or sham acupuncture either has a negative, no effect, or positive influence on IVF compared to IVF alone – this is the big question

    But now the title has changed to “Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization” So the only thing one can conclude from this study is that there is no difference between acupuncture and sham. They cannot say anything regarding the effect of acupuncture on IVF because they have dropped the third arm. If they did this intentionally I don’t know, but all the media reports states that acupuncture has no effect on IVF which in my view is completely wrong – they cant say it because we simply don’t know.

    Obviously most journalists get their info from the university’s press release and this is what they claimed “Fertility study finds acupuncture ineffective for IVF birth rates” – based on the data they can’t say it. So the question is why did they do it?

    http://nicm.edu.au/news/fertility_study_finds_acupuncture_ineffective_for_ivf_birth_rates.

  • I’m starting to think there may be something viable with accupuncture: provided they can refine the key elements from this “study”, is there a prospect of peddling as contraception?

    I given CAM’s marketing strategies, im reminded of an excellent proposal of religious counter apologetics: “the outsider test for faith”, first proposed by John W Loftis, whereby the apologist (catholic, Islamist, Scientology at, acupuncturist, homeopath, woo-merchant) is asked to demonstrate similar rigour investigating their own claims as they do when seeking to “debunk” others (scepticism, himanism, medical science)

  • This study appears destined for obscurity along with many others that fail to show significant advantage (or disadvantage) of acupuncture in treating some condition. It seems to me that the very fact of failure of the study to show improved results indicates a significant disadvantage to the patient who might be exposed to a useless treatment and the associated expenses of that treatment.

    Is any condition whatsoever improved by acupuncture?

    • Is any condition whatsoever improved by acupuncture?
      If you mean more than placebo + strong evidence, my answer would be: No.

  • Yes, but they are apparently above those rules. I’ve nagged about their failure to declare their conflicts of interests for about 2 years and eventually they started to declare something but it is still a rubbish declaration.

    They now have this standard version: “As a medical research institute, the NICM Health Research Institute receives research grants and donations from foundations, universities, government agencies, and industry. Sponsors and donors provide untied and tied funding for work to advance the vision and mission of the institute.”

  • Maybe I should write a letter to JAMA. It is a prestigious journal and one would not expect this paper to pass their peer review process. If you just look at the abstract, the first two sentences and the last sentence simply does not correlate – this study did not test the efficacy but only tested if there is a difference between acupuncture and sham. Add to this, they reported only half the results (intentionally omitting the rest) and that there might be some undeclared conflicts of issues/funding sources that has not been fully declared then I would suggest that this should be enough reason for the journal to withdraw this study. They should ask the authors to ‘complete’ the paper and resubmit.

    Part of the Abstract:

    “Importance: Acupuncture is widely used by women undergoing in vitro fertilization (IVF), although the evidence for efficacy is conflicting.

    Objective: To determine the efficacy of acupuncture compared with a sham acupuncture control performed during IVF on live births.

    Conclusions and Relevance: Among women undergoing IVF, administration of acupuncture vs sham acupuncture at the time of ovarian stimulation and embryo transfer resulted in no significant difference in live birth rates. These findings do not support the use of acupuncture to improve the rate of live births among women undergoing IVF.”

  • Good tips!I have truly understood importance here of this treatment. good knowledge for acupuncture and IVF you have shared here. I am so glad that I have come across your tips. Thanks a lot for sharing.

  • Dear Patrick,

    Hope you are well. Here are some great tips!

    The effectiveness of real acupuncture on live birth rates has not been sufficiently addressed in research. Yet.

    Edzard states “Laudably someone has conducted a trial so that we know the answer.”

    No, the trial did not provide an answer. The research set out to determine the efficacy of acupuncture compared with a sham acupuncture control, experienced difficulties, and then generalized findings.

    The Park Sham is a type of device that is used to administer both the acupuncture treatment and the sham acupuncture treatment. Acupuncturists do not use the Park Sham device to administer acupuncture. Administering acupuncture via the Park Sham device is not common practice, modifies normal administration of acupuncture and is problematic. The device may blind an acupuncture naive patient, however, this device does not serve as a tool to compare proper acupuncture administration.

    The Park Sham device and the corresponding Sham needle are not inert. There is pressure, sensation and the Park Sham needle dents the skin. There were limitations in the validation of the Park Sham device, ask Edzard about this he was the coauthor of the paper. The researchers of the study published in JAMA are correct to question the Park Sham device validity.

    Ok, so let’s modify the literature in line with the above knowledge for educational purposes: The women in this study received either sham device acupuncture (n = 424) or a sham device acupuncture control (n = 424)! Or live births occurred among 74 of 405 women (18.3%) that received sham control acupuncture compared with live births occurring among 72 of 404 women (17.8%) receiving sham control acupuncture!

    Not surprising!

    Edzard States: “This is a clear result and technically a fairly decent study. I say ‘fairly decent’ because, had the result been positive, one would have to question the efficacy blinding as well as the fact that the acupuncturists might have (inadvertently?) influenced their verum-patients such that they were less anxious and thus produced better outcomes. Moreover, the trial was under-powered.”

    If a trial is underpowered (along with other design issues) it is not technically fairly decent.

    PS A Cochrane systematic review described that studies were of low quality.
    All the best

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