Interview with Lee Hullender Rubin, DAOM, LAc, FABORM
Lee is clearly a decorated mover and shaker (see CV below). She is playing such a huge role in furthering the understanding of how Chinese medicine as a whole (which includes but is not limited to acupuncture) can help improve IVF success rates. her research is pioneering and is the first to attempt to capture the true holistic essence and power of Chinese medicine, so that healthcare providers and women struggling to get pregnant can more deeply trust and embrace this wonderful resource. If you haven’t done so already, it’s time to find yourself a Chinese medicine doctor with experience in reproductive health. Watch / Listen now. ~ Spence
Began practice in Washington state in 2002, and currently has an active license in Oregon since 2011.
Awaiting news of California License.
LICENSES and CERTIFICATIONS
State of Oregon Acupuncture License #153822 2011 – Present
Oregon Medical Board Supervisor Approval 2011 – Present
Fellow, American Board of Oriental Reproductive Medicine (ABORM) 2008 – Present
Fellow, International Society for the Study of Vulvovaginal Diseases 2017 – Present
Diplomate of Oriental Medicine 2005 – Present
National Certification Commission of Acupuncture and Oriental Medicine (NCCAOM)
State of Washington Acupuncture License #1879 2002 – 2016
Diplomate of Acupuncture 2001 – 2005
National Certification Commission of Acupuncture and Oriental Medicine (NCCAOM)
Clean needle certification 1999
Council of Colleges of Acupuncture and Oriental Medicine (CCAOM)
Bachelor of Science 1998 – 2000
Bastyr University, Kenmore WA
Natural Health Science in Oriental Medicine
Shanghai Traditional Chinese Medicine University, Shanghai, PRC 2001
Advanced Herbal Studies in Gynecology, Internal Medicine & Trauma
Master of Science 2000 – 2001
Bastyr University, Kenmore, WA
Acupuncture and Oriental Medicine
Doctor of Acupuncture and Oriental Medicine 2007 – 2009
Oregon College of Oriental Medicine, Portland, OR
Women’s Health and Geriatrics
Capstone: “Acupuncture improves in vitro fertilization pregnancy
rates: a retrospective chart review”
Mentors: Richard Hammerschlag, PhD; Tim Chapman, PhD;
Elizabeth Burch, ND
Post-Doctoral Research Fellowship 2011 – 2012
Oregon College of Oriental Medicine, Portland OR
Certificate 2011 – 2013
Human Investigations Program
Oregon Clinical and Translational Research Institute
Oregon Health and Science University, Portland, OR
Lee Hullender Rubin, DAOM, LAc, FABORM, is a clinician, international academic, and published researcher specializing in reproductive medicine, women’s health, and female sexual pain.
In practice since early 2002, she spent more than 5 years managing an acupuncture program at a western fertility clinic in the Pacific Northwest. Dr. Hullender Rubin was the first OCOM postdoctoral research fellow funded by a National Institutes of Health educational grant. Her most recent publication is the first cohort study to report an increase in birth outcomes associated with the addition of Traditional Chinese Medicine to In Vitro Fertilization. She recently completed a pilot study investigating the effect of acupuncture and lidocaine to treat chronic vulvar pain. She is on the faculty at the Oregon College of Oriental Medicine, American College of Traditional Chinese Medicine, and New Zealand School of Acupuncture and Traditional Chinese Medicine, and is Visiting Research Faculty at the Oregon Health and Science University. Dr. Hullender Rubin is relocating from Portland, Oregon, and her practices at the Portland Acupuncture Studio and Oregon Reproductive Medicine to San Francisco to pursue her dream job at the Osher Center for Integrative Medicine at UCSF.
Bastyr University, Kenmore, WA 2017
Adjunct Faculty, Doctoral program
American College of Traditional Chinese Medicine at California Institute 2017
of Integral Studies, San Francisco, CA
Adjunct Faculty, Doctoral program
New Zealand College of Acupuncture and Traditional Chinese Medicine 2014 – Present
Guest Lecturer, Master’s program
Oregon Health and Science University, Portland, OR 2013 – Present
Visiting Research Faculty, Primary Investigator
Oregon College of Oriental Medicine, Portland, OR 2011 – Present
Adjunct Research Faculty, Research Department
Distinguished Lecturer, Doctoral Program
Faculty, Master’s and Doctoral Programs
Clinical Supervisor, Master’s and Doctoral Programs
Postdoctoral Researcher, Research Department
Visiting AOM Doctoral Lecturer and Supervisor
Jade Institute, Seattle, WA 2008 – 2010
Bastyr University, Kenmore, WA 2007 – 2010
Adjunct AOM Clinical Faculty
Affiliate AOM Clinical Faculty
Acupuncture Associate 2016 – Present
Oregon Reproductive Medicine, Portland, OR
Private Practice 2011 – Present
Portland Acupuncture Studio, Portland, OR
Oregon College of Oriental Medicine, Portland, OR
Red Peony Acupuncture, Portland, OR
Private Practice and In Vitro Fertilization Acupuncture Program Manager 2005 – 2010
Abundant Spring, Bellevue, WA
Northwest Center for Reproductive Sciences, Kirkland, WA
Private Practice 2002 – 2005
Acupuncture Northwest, Seattle, WA
Tiger Mountain Center for Acupuncture, Issaquah, WA
Lee Hullender, LAc, Seattle, WA
Lee Hullender Rubin
Spence: Hello, everyone, and welcome to the Conception Channel Podcast, brought to you by the Being Fertile Program and the Yinstill Reproductive Wellness. I am your host, Spence Pentland, and today, I’m super excited to be able to speak with our special guest, Lee Hullender Rubin. Welcome to the show today!
Lee: Thank you so much for having me.
Spence: Awesome. I’m super excited, we go back somewhat and have been colleagues for a long time, but Lee is here today to help us better understand research and in regards to IVF in acupuncture or more accurately what we just discussed before pressing record, was the research with IVF and Chinese medicine, which acupuncture is a part of. And that’s language I think we all want to change because acupuncture is much more than just the insertion of needles into points, and Lee has been building the Trojan horse to try and create change in that respect. And I’m super honored to have someone so dedicated in our industry, which would be Chinese medicine, that is so committed to helping everyone better understand what Chinese medicine is doing for them and how it can benefit them on their journey to babies basically.
Lee: Thanks so much, that’s so kind.
Spence: Well, that’s my intro, and as we also discussed before that, usually when I have a guest on the show, they send in a little form so I’ve got their professional profile and achievements and experience, etc, and often I can summarize that and that goes in the intro that I give, and sometimes when it’s longer, I’ll just read it. But with Lee’s, it’s too long for either of those, so what we’ve decided in tradition of the — it’ll all be in the show notes — I mean, she is extremely decorated and has clearly dedicated her life to furthering her education and a lot of other people’s education in the academic world and clinical world as well for acupuncture. So, what we’re going to do in tradition of the show is just dive back into your story. She agreed to kind of give us a little bit of a background and, you know, if you’re trying to get pregnant or maintain a pregnancy and are considering IVF, Lee is the person that you want to listen to so you can best understand what some of these adjuvant therapies in
particular acupuncture can do and Chinese medicine can do to help you to be successful. Without further ado, Lee, welcome, and can you give people a bit of your background so I don’t fumble around and do it and injustice?
Lee: You’re so kind. Thanks again for inviting me, Spence. We do go back many years, actually, I think I met you at a conference or a session for training in like 2004 in Vancouver, when an Australian researcher, I’m sorry, clinician came and taught in Vancouver I think. You know, I’m just like you in many ways, I’m a clinician. I became a clinician as an acupuncturist and herbalist and Chinese medicine professional or I guess some people also say East Asian medicine, to be a little more region nonspecific. I really chose to specialize in reproductive medicine just because it was just so deeply fascinating and there was some new research coming out that made it very exciting, so when I was in grad school in Seattle, which is where I really started out, I took a class, a special class and it like just sort of ignited the fire of like, oh, this is so cool, women’s health, getting pregnant, helping them get pregnant, and I found someone to mentor me, and then once we started working together I just kind of like took the ball and ran with it. I was very fascinated with the fact that in Chinese medicine as well as in Reproductive Medicine, you have a really clear outcome – are you pregnant, are you not pregnant, do you have a baby, do you not have a baby. It’s a yes or a no. There’s not a little bit.
Lee: It’s pretty black and white, there’s no gray area. You’ve got a scale and there’s a lot of movement in that, but I think that’s very appealing to me about because it’s neat in many ways. Again, no gray area. I had originally started practicing and, as I said, was mentored by this wonderful woman named Christina Jackson in Issaquah, Washington. I started on a research study in the Seattle area and it was one of the first studies that was actually kind of not positive actually. And a fellow at the University of Washington had invited myself and another colleague of mine to be the acupuncturists on that study, and we did. On the day of embryo transfer, you give people acupuncture on the day that the embryos are placed back into their womb. We did it at our clinic in downtown Seattle, and the women would come from the fertility clinic, which it wasn’t very far, it’s a couple of miles, but our clinic was right downtown. It was like in the hubbub of parking, you know, and they had never been there before and if anyone in who’s listening today knows, that is a very stressful day. If you’ve
never been there before, I think that may have negated any benefit that we might have had for those patients because when we got to the results of the paper, we found that there was no difference between the women, actually there was a difference, the women who did not have acupuncture had a higher pregnancy rate than the women who did not have acupuncture. I didn’t say that right, I’m so sorry. The woman who did not have acupuncture had the higher pregnancy rate, the people who did had the lower pregnancy rate.
Spence: The unexpected result.
Lee: I’m noticing my headphones aren’t working, so I’m just going to turn them off and speak to you like this. So, that really lit a fire because I was like, that’s not what I’m seeing in the real world, like, what is happening here. And so I had taken that protocol that we were using off-site to another IVF clinic and I was doing it on site. And when the results came out on a big research conference, there was lots of press, I was getting a lot of email, that’s the one thing about being a researcher is one cannot be attached to the outcome, which is also a lesson in trying to get pregnant frankly. But ultimately, I just had to sit back and kind of like think about what did happen here, what could be the contributing factors to understanding why did we get a negative outcome versus a positive outcome. That was really what started my deep interest in research in addition to my already present and fascinating interest in reproductive medicine.
Spence: Cool. That would lit a spark as well. I mean, it was Einstein I think who said, as soon as you observe something, there’s a bias of some sort. |You obviously were stepping in with, if it wasn’t outwardly, inwardly a belief system at the very least or a hope probably as well that acupuncture would clearly help because you’ve seen it clinically, and when it didn’t, yeah, that would have lit a spark as well. And to date really, to be clear, is that one of the few studies that has had that negative impact or shown that negative result?
Lee: It is the only study that has had a negative result, and it’s the only study where women were randomized into the one of two groups and the acupuncture was performed off-site from the IVF center. When I looked back at our outcomes at the IVF Center where I was doing it on site, I actually saw it did not have a negative impact. In fact, it was about the same as the women who just didn’t add it at all in women who had an IVF cycle with their own embryos, which were never previously frozen. This was at the late 2000s when frozen cycles weren’t as
popular as they are now.
Spence: Yeah, there’s a different style of — that was a question, because we’ll get into your study that came out, this landmark study that I’m so excited about because it really embodies Chinese medicine as a whole, which it is, you know, that doesn’t just include acupuncture. It’s maybe herbal medicine, it’s maybe dietary lifestyle, recommendations, etc, it’s a whole view of an individualized protocol or individualized treatment for each patient. With the whole systems, in 2015, that was, right? Is that when that study came out?
Spence: So, you started working on that back when IVF techniques were a little different, so frozen embryo, the freezing technique was different than it is today the vitrification and a few things were different. I even remember I think the PGD sometimes was maybe done day three and there’s a few unique things, but as a whole, this is the first study that really was well powered. I’m going to help interpret what that means to people. I’m going to back up a second. I think a dangerous aspect of research when it gets into the hands of media is pulling little snippets or media bites from conclusions or the discussion that can make big claims, and unless you really understand most aspects of what happened in a study, you should be cautious of what you’re pulling from it. If you‘re just someone reading a newspaper headline or something, because there’s so much that goes into it and maybe, Lee, you could touch it on some of that. And then segue into why and how you set up the whole systems research.
Lee: I think you just touched on power.
Spence: Power, yeah, sorry.
Lee: Right, exactly. If you want to adequately power a study, what that really means is like do you have enough people in the study to truly detect a difference between groups. Like, is it really fair to expect that a group of 10 compared to another group of 10, let’s say that group A has a 70% pregnancy rate and this one has a 30% pregnancy rate – that’s not really generalizable to the greater population. So, adequately powering means that you have more people and you can draw a stronger conclusion if there is indeed a difference or even if there’s
Spence: Right. Maybe a way to highlight that, if there were just two people in a study and one of them got pregnant, that’s a 50% success rate. But that’s clearly not going to represent the whole, so as that gets larger and larger, it gets more accurately representative of what the world would look like.
Lee: But what you’re also kind of talking about is validity. So, power helps ensure validity, but the second piece of that is that you have to make sure the people in both of the groups are equivalent as much as possible, that they’re not different, so that you haven’t sort of shunted the positive people to be in your group that you want them to be positive, and making the people who won’t get pregnant in your no intervention group, that’s a trick that sometimes happens in some research, which, if you’re not careful, you wouldn’t notice that. Anyway, if we come back to what we were talking about with respect to the study that had the negative impact because I just wanted to finish that thought. That first study that came out in 2007, we finally were able to publish a paper in 2014, and the acupuncture on the day of embryo transfer had a lower pregnancy rate than the people who didn’t have it. That same protocol, which was provided on-site at the clinic I was working with, there was no difference between groups, it did not harm anything, and in fact, actually helped women who were having donor egg cycles. That means very similar, but that was smaller in number. So, then, we were running into this issue of power, but it was a significant enough difference, where we could at least say, okay, there’s clearly a signal here. And if we could adequately power a study and look at a randomized control trial, we may be able to see something. I think the other thing that you can do from looking at using that protocol on the day of embryo transfer for donor cycles, you may be able to extrapolate that because it’s a very similar cycle type to frozen cycles. And the success rates now with chromosomal screening are about equivocal with the donor cycles. I mean, it’s a signal, it’s something we could draw from to do future research. I would love to do that one day, maybe hopefully we will.
Spence: Go, Lee, go, Lee!
Lee: But, money, money, money. My point ultimately is that we’ve still got ways to go, but even though that one study was negative, it wasn’t the protocol. The protocol was not the
problem. Because of that observational research that we did afterwards in that clinic where I was working, I think we could actually say, probably it was a location. It probably was a location of treatment on a day when it’s very stressful and those women had never been there before.
Spence: So, the takeaway there, adding the stress of travel downtown Seattle, I’ve been there. And already a huge day likely had an impact.
Lee: Yeah, but it may have.
Spence: But highlight it, you know, at least when compared to the same done on-site. That’s the exact study why we recommend the on-site and, you know, the reproductive endocrinologists or IVF docs that we work with all understand that as well and are so great. And it’s happening more and more all over the world where acupuncturists are on site and that’s fantastic. Even though that was a negative impact what’s come from it is that exact understanding. It’s huge. And what I understand and how I see it is, we’re one of the only people sometimes when we’re on site at an IVF clinic that is they’re strictly for the woman, not the embryos. And it’s kind of a support that is quite unique. It’s an honor to be there on that day.
Lee: It is. I share that feeling with you so much. I still do. Well, I just finished doing it. For the last two-and-a-half years I was part of the Oregon reproductive medicine acupuncture team doing the same thing. I was on site at least one day a week and once every five weeks on the weekend, providing the same type of treatment on the day of embryo transfer and it’s such an important day. And to have that and hold that space with them, where it’s all about let’s bring this embryo to you and place it in your room and let’s support implantation. Like, that’s really our goal and help you to be as relaxed as possible.
Spence: And receptive. So, the difficulty with studying acupuncture and that’s what mostly things has been researched so far, here’s a protocol of acupuncture points, does it help or not usually done on embryo transfer day. And we’re a holistic medicine, we individualized treatments, and so, fitting acupuncture into randomized controlled trials is kind of like fitting square peg into a round hole. People have tried to do it, and largely, there’s at least been shown
some benefit. They’ve tried to include sham, which is different, or placebo effect, which is really easy with drug trials but more difficult when — are you putting a needle in someone or not, it’s kind of hard to placebo that, but anyway, that is why your study is so special. The whole systems that came out in 2015 in reproductive biomedicine and because you compared three great groups and literally can compare apples to oranges, which you should be able to do in research and attempt to try and qualify and quantify the essence of how Chinese medicine is trying to help and what it can do and how it may change outcome. You’ve helped me set up our research spreadsheets years ago.
Lee: Oh, yeah, that’s right.
Spence: We included Chinese medicine diagnostics over these years too in that. I’m excited that some days you’ll get your help to kind of extrapolate. Can you tell everybody who’s listening why you wanted to step into that whole systems traditional Chinese medicine, and how you ended up, you know, the thought process of setting it up to try to bring light to how Chinese medicine as a whole helps more than maybe just acupuncture?
Lee: I think that’s a great question. Ultimately, we’re not just talking about one intervention of sticking needles in someone. When someone comes to us, we also help with diet, we help with lifestyle, we might suggest some specific nutritional supplements like a prenatal or vitamin E or something like that maybe, maybe even fish oil. If we think it’s appropriate for that particular person and not everybody’s going get everything, but that gets to be lots of little pieces and so do you pick out each little piece and say, oh, well does that work, or do you look at the global thing, the whole system of the intervention, which is the acupuncture, maybe even Chinese herbs, the lifestyle, the diet and maybe kind of think of that as just one intervention because in many ways, IVF is one intervention. And while they have picked out each of the components to see which is the most effective in a group of other drugs alongside the other procedures, we don’t have a luxury of being able to do that. I think the first step really was to say, okay, people are coming to my office, there’s this idea of a whole system intervention, a whole systems research. I wanted to call it whole systems traditional Chinese medicine. It was not coined by me, it was coined by this fabulous researcher here. Actually it was at Kaiser, her name is –oh, my gosh, her name is escaping me at the moment, it doesn’t matter. Anyway, Cheryl Ritenbaugh. So, Cheryl coined the phrase and they sort of like
developed research that looked at different systems of medicine like Chinese medicine versus naturopathic medicine versus your usual care, which is another whole system of medicine. So, for IVF no one has looked at this but what happens is people come to our practices and they get a much more comprehensive intervention rather than just acupuncture. We don’t walk into the room like a robot, put in the same points and walk out the room. We talk to them, we get a really good sense of what are your individual needs. You know, what brought this endometriosis person here is probably very different from the next endometriosis person. And the same thing with the polycystic ovarian syndrome, this person might have more insulin resistance, whereas this person has just irregular cycles and more cysts, something like that. So, these are very different presentations. The beauty of Chinese medicine is that we can actually use that information to help us develop our treatment plans. And really, well, you can’t really capture that in a standardized protocol, can you?
Lee: Which is what you were just talking about a little bit ago. So, this paper basically is all about looking at that global intervention, not separating out the ingredients, because I didn’t want to overestimate one ingredient as being more powerful than another. I wanted it to be the sum of all parts. We compared that Chinese medicine to people who just came in on the day of embryo transfer, and we compared that to just the people who just did IVF with no other interventions. So, those are three groups.
Spence: Thank you for the pause. Everybody’s seems okay, they’ll walk into an office or google – what is the success rate of IVF? And you said it perfectly and people should know, you know, IVF you come in you see a physician, you get put through testing and diagnostics to find out what different interventions even within an IVF would work better or worse for your case, and largely, in many respects, you would be individualized to some degree. I mean, obviously not holistically, but your treatment is going to be catered somewhat to you and different drugs, different everything, ingredients that you’re talking about would have separate research. But people just want to know how does IVF help or what’s its success rates. And so you’re trying to just do the exact same thing with Chinese medicine because no one that practices acupuncture Chinese medicine would just walk in, put in points, walk out of the room and that’d be it, their emotional and spiritual support, they’re recommending
supplements or diet or whatever that person might need and whatever maybe even the practitioner might be a little more adept at. Okay, that’s a great clarification. A lot of the research have been done on just acupuncture on embryo transfer day and there’s plenty of IVF without any intervention, so you included this whole systems as a third arm in this study. So, what did you end up seeing?
Lee: When TCM was added to IVF, it was associated with a 93% increase in the odds of live birth compared to everyone else.
Spence: To live birth?
Lee: To live birth. We went to the final outcome, which is delivering a baby, not just getting pregnant, because I think for me, personally, I was more interested in live birth. So, I didn’t just want the clinical pregnancy, like the positive pregnancy rate at 6 weeks and 8 weeks, and the ongoing pregnancy that once they’re released from care from the IVF center, I wanted a tangible outcome. Well, they’re all tangible because what I mean with the final outcome.
Spence: That’s what every woman wants.
Spence: That’s the only measure that really makes long-term sense.
Lee: Exactly. Like I said, Chinese medicine was associated and when I say associated that means that I’m talking about observational research. We did not randomize these women, we just looked back at five years of data and compared them because the groups sort of just naturally emerged. We had women came to my clinic and got Chinese medicine, we had women who specifically requested day of embryo transfer acupuncture at the IVF Center, and then we had clearly the data for the women who just did IVF without any other known interventions. Now, it is possible the women who didn’t have any other known interventions could have gotten it somewhere else and we just don’t know.
Spence: It wasn’t reported.
Lee: Yeah, it wasn’t reported, so that could mean that we may have underestimated or overestimated, we don’t know. But that’s the beauty of observational research, you can kind of at least get some basic information. From there, you can then inform randomized control trials. Okay, let’s go back to TCM and its influence on outcomes in this particular cohort. So, these are women that went through IVF from 2005 to 2010, we just said that TCM compared to everyone was associated with a 93% increase in the odds of live birth – that’s a huge, it’s almost a two-fold increase if I just compared Chinese medicine to women who just did IVF. And those were the only two groups that I was looking at, they were associated, the TCM people were associated with a 109% increase or definitely a two-fold increase in the odds of live birth. So, essentially, they were associated with doubling the chance of getting pregnant. And then when TCM was just compared to that day of embryo transfer acupuncture, the TCM people had increased odds of life birth of 62%. So, we still had a substantial increase, it wasn’t two–fold but it was 62%, which is still very, very good. Those were with women that had had an IVF with their own eggs.
Spence: And fresh, right?
Lee: Yes. They were all fresh. And there was a lot of women, there was like over a thousand women in the whole study. There were 119 in the TCM group, 580 who just did IVF alone, and 370 who did acupuncture on the day of embryo transfer. We, as you were saying earlier, helped people who were adequately powered.
Spence: Yeah, that is fantastic. I remember reading something else, you said some of the people in the just IVF group may have had complementary or some sort of wellness and health interventions as well, just not report to their physician, so how could you ever know. That would be in favor of whole systems Chinese medicines outcome as well. Also, I remember you stating in your study that the average age in the TCM or the Chinese medicine whole systems group was higher, and the diminished ovarian reserve rates were also higher – is that correct?
Lee: It wasn’t actually that much higher for age. There was no difference between the groups, I’m looking at it right now. There was no difference in the groups between age at the time,
FSH was the big predictor of outcome. Now we use AMH, as you know. But FSH at that time was the big one, so there wasn’t a big difference between them. The thing that was different between the groups, and we accounted for this in our analysis to make sure that it didn’t have like this really huge influence on the analysis, but the diagnosis of diminished ovarian reserve was higher. They had a 31.1% incidence of diminished ovarian reserve in the TCM group, whereas there was only 20% in the usual care or the IVF alone and 21% in the acupuncture group. The other thing that was different that is I think really important to notice is whether they had failed a cycle before. So, there were more women who had failed a cycle and the TCM group. We know, actually in practice anyway, that we usually see people who have failed many times, they’re just like, I just want to get pregnant, I’m going to do everything I possibly can, make my diet better, make my life better, just make me feel better, let me get pregnant. So, we had to account for that and the analysis as well. And we did we actually. I did this specific type of analysis, which is called Multivariate Logistic Regression. I’m not going to go into all the details of it, but just suffice it to say, actually when you have variables like this, differences in characteristics of people, you can use that as a variable to address its influence on the outcomes.
Spence: To get more accurate with the information that spit out. Okay. If I remember correctly, there’s been some other research that points to Chinese medicine or probably more accurately, acupuncture, helping more in groups with diminished ovarian reserve – is that mega rally, I forget, it was early on – am I right in saying that?
Lee: I think you are. I think he looked at what were the characteristics of women who best respond to IV, and I actually did a secondary analysis on the same cohort, kind of asking the same question. He first looked at age and then he looked at diagnosis, and so I’ve looked at age as well. He found that it was roughly the 37 – 40 year old women that benefited the most and I found a similar outcome when they added traditional Chinese medicine. The women who were aged from 38 – 42 got the most benefit. They were associated with more live births compared to the other groups.
Spence: And this is live birth. I need to reiterate that because that is a baby. At the Canadian Fertility & Andrology Society, it’s the equivalent to the ASRM in the U.S. It’s an annual conference, where medical specialists get together and discuss fertility and andrology and
different presentations. Anyway, there was a debate and I ended up getting to chat with one of the guys from the Netherlands I believe. A brilliant, brilliant! I’d be terrified to ever be toe to toe in any discussion with him, but brilliant mind, and we were having lunch and he talked a lot about statistics and how the live birth is really the only statistic that matters because it’s the only statistic that matters to the patient and anything else is irrelevant, well, not irrelevant but should only ever be used as clinical data for the most part to understand how to better practice and treat. And often clinical pregnancy rates are used to display effectiveness of a lot of clinics to the public IVF clinics. It can be quite misleading when actually you have no idea what the live birth rate is and that is truly what matters, so thank you for that being your endpoint in your study, because that is what matters. Something about whole systems, the major difference between whole systems and women that come in and say, well, I heard acupuncture helps on embryo transfer day, can I have someone meet me on site, there is a time between when a woman or/and men start maybe — we’ll touch on that too — start diving into maybe a wellness and health plan for themselves with the practitioner of Chinese medicine between them, and when they start stimulating their eggs and having egg retrieval and embryo transfer – so, there’s been a few studies looking at that ideal time and treatments and, you know, sometimes people come for three, four treatments beforehand, and maybe an example would be polycystic ovarian syndrome, sometimes a dose of 24 or acupuncture treatments with some time to help reregulate insulin resistance and a few things is important – can you touch on what kind of the range and what was found and included in the study?
Lee: I think I understand your questions.
Spence: I don’t understand my question.
Lee: No, I think you are asking about a dose, and this is a really good question because I think we have this expectation that two acupuncture treatments on the day of embryo transfer are going to magically make everyone pregnant. And that’s just not the case, especially as IVF centers are getting better and better at their jobs. It does have a benefit of at least helping support someone be more supported and less stressed and more receptive on that day, but as far as like improving pregnancy rates just the day of embryo transfer as an intervention is likely not enough, and that the more accurate intervention should be something a little more comprehensive like I talked about in my Chinese medicine, my whole systems Chinese
medicine paper. Something like twelve sessions for a non-donor cycle, a woman who’s using her own eggs, eleven or so with the frozen or donor cycles. So, dose is something that we haven’t really nailed down yet, though. So, this is just a suggestion based on the literature and this last paper that I wrote in acupuncture and medicine was really kind of like getting to that, like we can’t just assume two treatments are going to be enough. And so part of our education to patients and part of our education to providers is that we have to be thinking about a more comprehensive intervention. One that can actually provide the benefit that we think it can. If we go back to your question of dose, what is the adequate dose, it depends on many different factors like what is the diagnosis of the patient. In some of the research that you just referenced where there was 24 sessions with polycystic ovarian syndrome and that work is really, really good on establishing the fact that when acupuncture, electro acupuncture specifically was compared to exercise, it was at least as good as or better to improve androgen levels that were elevated, improving insulin sensitivity. You are reducing really high AMH, so really high AMH is not good, really low AMH is not good, it has to be, you know, like Goldilocks, just right. So, it helped to normalize that. That type of research is called comparative effectiveness research. You also touched upon earlier about the statement of trying to compare acupuncture to a placebo, and we actually can’t do that. We don’t fully understand the mechanisms of acupuncture yet to be able to say definitively, we can account for all of those and this is truly a placebo that it actually has no unphysiological effect at all. But what we can do, and there’s a lot of researchers coming out now where we’re like, okay, we think acupuncture has a benefit, so let’s compare it to something that you know does have a benefit. Let’s take acupuncture and compare it to exercise for the polycystic ovarian syndrome people, and it did just as good or better on those outcomes. Now, I will say that, and that was 24 visits by the way, so, another study that was done by that group, they started with 8 sessions to look at blood flow to the uterus doesn’t actually increase it, yes it did with 8 sessions. So, again, on the same day, it was 8 sessions over 4 weeks, and in another polycystic ovarian syndrome study, it was twice a week for 8 weeks for 16 total sessions. And they compared that to, I believe also exercise but don’t quote me on that, it was not a placebo acupuncture. And they looked at other parameters on polycystic ovarian syndrome patients that I actually can’t remember off the top of my head. It’s probably in this paper here, I’m trying to just scroll through at the same time.
Spence: The same time as you’re speaking to the audience, multitasking.
Lee: Yes. I am multitasking. So, I will say this, in my paper, 11 acupuncture treatments, during an IVF cycle, were associated with significantly improved IVF birth outcomes and fewer miscarriages, and that’s something we actually haven’t talked about. So, not miscarriages, fewer on biochemical pregnancies. So, in the TCM paper what we found was that if someone got pregnant, they likely stayed pregnant. They had fewer implantation failures, fewer biochemical pregnancies, significantly like a 75% reduction in the odds of having a biochemical pregnancy. So, if they were positive, most likely they stay pregnant. They had fewer miscarriages, but it just wasn’t statistically significant. It was clinically relevant, though. We don’t know what the optimal protocol is, but ultimately, I think we as a community have to be thinking about how many sessions do we really need. And I think a baseline to start, just based on this literature that I did, was roughly 11 to 12.
Spence: Yeah, clinically, and this isn’t documented, this is just our own internal review why we keep statistics to try and find out how we’re doing, ultimately that’s what it should be about, it was somewhere in that same vicinity, the average, the people that we are successful. The last time we pulled data was about two and a half or about eleven to twelve treatments in about two and a half month period of time, these are all averages and we’re not all stats. I mean, some people require a bit more than others and that should be a discussion with you and your practitioner and hopefully someone who does have some experience treating reproductive health and supporting women going through IVF because they’ll have a better grasp on that. Okay, before we just hop into your other studies that I had no idea that you’ve touched on already but did the male side factor in any way or was it a variable that was left and maybe that would even improve things more, that’s my belief?
Lee: I wish I could say that, yes, we treated a lot of men but we didn’t. I don’t know what it’s like in Canada, but I can tell you when I was practicing in Seattle, it was really difficult to get the men to come in to have practice or treatment, same for you?
Spence: Canada’s not unique.
Lee: So Seattle and Canada are comparable in that respective. What I do know is that all of the three groups that were in the study, male factor was an issue in 40% of the TCM cycles, 36 in
the IVF alone cycles and 35% of the acupuncture only cycles. So, they were comparable, so it was pretty evenly distributed between the three groups, so that’s good. If that was different, we would have used that as one of our little variables in our analysis. Did we treat enough males to actually be able to say anything? No. I wasn’t able to include them, it was really all about the women.
Spence: I understand, and that’s common everywhere. I mean, how could we improve success rates, you know, work with men.
Lee: I agree, and I think ultimately that the statistics, not that I’ve done it, that male fertility is declining and we have to figure out ways to help preserve it. I think Chinese medicine has something to really offer here, but we need to verify that. This is part of the reason why I became a researcher. I see what’s happening, but I want to verify it.
Spence: Thank you for appeasing me with the male side, I just feel like it’s hard to get men in, they don’t always have to get needles, I get it. They are terrified of needles, you know, they’d rather take a bullet, but we can look at herbs, diet, lifestyle. Some men have never had a conversation with anyone about not wearing synthetic underwear in synthetic pants sitting on like a synthetic chair all day at the office and cooking their balls. Heat, the number one enemy of sperm. But, anyway, I digress. Something more recent, last year you talked about age , does age matter, and you got that published in Fertility and Sterility, congratulations. What was the discussion about on that paper?
Lee: It was just an abstract I presented it at the Annual Congress of the American Society for Reproductive Medicine similar to the Canadian Society when you were just talking about, and I just presented it this past fall, so it’s 2018, 2017, I’ve forgotten what year it was. So, what we really found is that there was a trend towards a significant difference in live births in women aged 38 – 40, compared with all cycles, and that was statistically significant. And a clinically relevant difference in the women that were under 35 and aged 35 to 7 when TCM was compared to other groups, now it wasn’t statistically significant, but I can send you the actual abstract so you can post it for everyone to see.
Spence: That would be great, it will be in the show notes down below.
Lee: If people have questions, they can email me and I’m happy to discuss it with them and I’ll give you my email as well.
Spence: Like a conclusion, like a takeaway.
Lee: The main thing is that age is likely a consideration, women under 35 typically will do fine, they’ll do pretty okay without adding Chinese medicine. It’ll benefit them up in other ways. It may not actually improve their live birth rate but it could actually help them be more resilient during this very stressful process. One of the biggest reasons why people stopped doing IVF, it’s been very clearly described in the literature is that the stress is so overwhelming that people are just like, I can’t do this. So, Chinese medicine has so much really good literature about stress reduction, helping being more resilient, helping support anxiety and depression – all good things to help with women trying to have babies and build their family. The other aspect here is that how I concluded this was that age may be a consideration when integrating acupuncture or Chinese medicine with IVF, and it could benefit the women aged 38 and older more significantly, so in my study, we found that when you added TCM to IVF, it was associated with an increased odds of live birth in women aged 38 – 42. So, those were the women that really benefited the most, the 38 – 42 year olds. And we know that that’s kind of logical. When you look at the charts that look at how many eggs people have, we really start to see that decline from 37 – 40, and 41 – 42, it’s a very steep decline. Chinese medicine may, we don’t know this for sure, but we may be able to improve the dynamic between the ovaries, the pituitary and the hypothalamus so that they work more efficiently. We may be having an impact on blood flow, which then could have a primary impact on its physiology in that way. We may be having an impact on the neurotransmitters that then tell the deep brain to release all the things that tell the pituitary to release the things to tell the ovaries what to do, as well as just helping people to feel less stressed. We definitely know Chinese medicine, specifically acupuncture helps patients release more endogenous opioids which helps them to relax. So, you know, this paper is a small paper because I had to differentiate by groups, so we’re talking about power. This particular paper is a little less adequately powered in my estimation. I would say that the small numbers in the groups limit the strength of our observations, but it’s still another signal that’s similar to someone else’s work, Dr. Pirelli’s work, where women aged 38 and older responded better to adding
acupuncture to their cycles.
Spence: So, that’s the takeaway. That is the population that more often would seek out – I understand time and therefore I am going to pull out all the stops. And sometimes, at least clinically what I see is, let’s not pull out too many, let’s not make, well, I call it hyper wellness becomes a stressor. That’s a fully different conversation. So, from here forward, you probably haven’t retired from researching, so what’s next, what kind of direction or what kind of understanding or further information are you trying to extrapolate from your research?
Lee: Well, I think the next thing that I am planning is I’m relocating to San Francisco, I’m taking a position at research institution. I will be a clinician still, first and foremost, that’s my love, and I don’t think you can be a good researcher without actually being a clinician if you’re talking about medicine. But I would like to describe the characteristics of the intervention of Chinese medicine a little more clearly, so my next paper will be fully fleshing out this abstract that I presented in addition to talking about the characteristics and probably adding in a little bit more about diagnosis and looking at perhaps who responded better based on biomedical diagnosis. And then I also have another research interest, which is in female sexual pain. I did the pilot study on that, so I’m writing that paper, I’m in the middle of writing that paper, in the middle of moving, in the middle of relocating.
Spence: Well, it’ll keep your mind occupied while you’re packing boxes. That’s interesting you touched on that and I’d love to just off the podcast chat about, I’ve really been integrating pelvic floor physiotherapy into more of my cases, and that being something actually that I postulate an early observation of clinically, just clinically of younger, more unexplained cases. Anyway, I can go deeper into why I think that, but it’s not research and that’s not why we’re here today with Lee, these are my thoughts, but maybe we can correlate and chat more too about our clinical research with the Chinese medicine diagnostics that we have. One last thing with research is once you’ve got it done, that’s great, but when someone else like you sit kept talking about it, we kind of pulling the same conclusions as another study when more studies draw similar conclusions, it also gives it more validity, correct?
Lee: Yeah. You’re building the evidence to help on say, it is there, there and there. Ideally, we would prefer to have research that is all randomized control trials, but as I said earlier, it’s
really challenging for us to do that, that is the gold standard, a randomized control trial. And so, as time goes on, we’ll try to do more trials that compare acupuncture to say mind-body programs or cognitive behavioral therapy, that sort of thing.
Spence: Yeah. It’s always nice to pair up with IVF because it’s a protocol and there’s a clear start and end date to it. Thank you, thank you so much, Lee. Some of the takeaways for me are that the whole systems helped with live birth in a well powered study that you did, thank you so much for doing that. We touched on dose, which is ,acupuncture isn’t magic and health and wellness doesn’t happen overnight either, be realistic with how you’re stepping in. And we didn’t even go into miscarriage or maybe we could another time, male factor again maybe a really, that’s my one of my pearls, may be something really beneficial to work with some. And to just bottom line, get people to start thinking about Chinese medicine as a whole versus just acupuncture and working with someone that you trust that has some experience. If you’re prepping for an IVF, it’s so important to be holistically ready for it. It’s not essential but I’ve seen so many women go through it as you have, you know, thousands. And even nurses at local clinics have admittedly said verbatim that we can almost pick out in the waiting room acupuncture patients versus non. It’s great, right? If you can step through something, it’s not going to take away the stress of it but it might mediate how your body and your psyche will deal with it and the reactions to it. But anyway, thank you so much. How can people learn more, get a hold of you, we’ll put some links in the show notes?
Lee: So, since I’m in transition, just email is probably the best. It’s firstname.lastname@example.org.
Spence: I’ll put it in the show notes.
Lee: Great, thank you!
Spence: Well, good luck with your moving to San Francisco. I’m excited someone else to visit in such a great city, not that Portland isn’t amazing as well, I’m sure you’ll be sad to leave, but if you have any questions, ask Lee, and I hope this kind of clarified a little bit, that was my intention. It’s hard to take off the clinician hat and translate research into terminology that is really relevant, and also if there’s a physician or two watching, so they pulled something from this too. I know we’re always dancing between that. Thank you so much, Lee, you’re doing so