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235 The Fairness of Evidence Based Medicine in IVF with Professor Charles Kingsland

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How does shaking hands on transfer day, and the day the news broke about Princess Diana’s death have to do with evidence- based reproductive medicine?

Professor Charles Kingsland,the chief medical officer of Care Fertility in the United Kingdom, with over 40 years of experience, reviews the spectrum of standards for evidence based medicine, and draws the line on what he thinks is fair.

Kingsland shares his own blending of evidence-based practices with personal rituals.

Tune in as Professor Charles Kingsland explores:

  • The role and importance of evidence-based medicine in reproductive healthcare

  • His unique perspective on the necessity and limits of evidence-based practices

  • Personal superstitions and rituals he performs during IVF transfers

  • The interplay between nationalization and privatization in the field of IVF

  • The impact of daily news on his medical procedures

  • The balance between strict medical evidence demands and patient freedom

  • The ethical standard of "do no harm" and its relative interpretations

Listen here and now

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Transcript

[00:00:00] Professor Charles Kingsland: I have to shake everybody's hand in that theatre. So I shake the nurse's hand, the embryologist's hand, the patient's hand, and the patient's partner's hand. Because if I do not shake their hands, they're not going to get pregnant. Now, you cannot tell me that that is impossible. Evidence based, but I, it's important to me.

[00:00:20] Griffin Jones: You know who brought this rich conversation with Professor Charles Kingsland to you for free? Asian Egg Bank. Listen to the name, Asian Egg Bank. You know your patient populations. You know their needs. So you probably know you're going to need Asian Egg Bank. You might want to start that relationship now if you haven't already.

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[00:00:52] Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you.

But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.

[00:01:17] Griffin Jones: Do you practice evidence-based medicine? Are you sure? How much of it should you be practicing? All the way to the extent that every treatment or therapy has an unequivocal benefit to the patient? Or is there room for, nay a need for, the fringes of medicine, provided that the measure in question does no harm?

I wax philosophical on this topic with my guest, Professor Charles Kingsland. He's a reproductive endocrinologist and the chief medical officer of care fertility in the United Kingdom. He's been at this for a wee bit, 40 years. He worked with Dr. Robert Edwards. He saw the early days, saw privatization, saw nationalization, and the mix of those two in IVF.

Charles talks about the different grades of evidence. He talks about his own superstitious practices, which I find pretty hilarious. He does this after or before every transfer. And why the big news story of the day matters to him when he's doing transfers. Why he still does these little rituals even though he knows it's superstition and nothing based in evidence.

And what demands of evidence based medicine he feels are necessary, and which demands are unfair to the patient's consumer freedom. We talk about the standard of do no harm and the relativity of the range of harm. Charles was a fun guest. You're gonna like him. He's an engaging guy to have a conversation with.

And there's a lot more that I wasn't able to get to this time, but I will have him back on for a future episode for, and I alluded to that theme at the end of this conversation. Now have at it. Enjoy this interview with Professor Charles Kingsland. 

Professor Kingsland, Charles, welcome to the Inside Reproductive Health podcast.

Professor Charles Kingsland: Yeah, thank you very much, Griffin. It's great to be here. 

Griffin Jones: You're now the third guest from CARE Fertility that I've had on the show. I've had Professor Campbell twice. I've had the CEO, Dave Burford, on once. People are going to think that I don't give any other representation to any other UK clinics. It's partly because CARE is so big and so there's different roles of folks to talk to.

It's also because I've gotten to know some of you over the course of the years. I am amenable to having other UK guests on, so if there are other UK CEOs and clinicians, you're welcome on the show. Just drop me an email. Charles, you and I, I believe, have only met in person once. We met very briefly at a dinner hosted by our mutual friends, Joshua and Alan, but I understand that you've been in the space for not a short while now.

And you may have seen some changes over the years. And I want to talk about those changes. I want to talk about that within the context as the ventures that you're involved in expand to different geographies. But maybe you could set the scene of just your initial foray into this space and, and give us the summary of how it's developed.

Yeah, 

[00:04:02] Professor Charles Kingsland: well, I, you know, after the show, Griffin, I can give you some names of, of of other colleagues in the UK. I'm sure they'd be more than happy to to join you. 

[00:04:11] Griffin Jones: Of people that don't work for you?

[00:04:11] Professor Charles Kingsland: Yeah. And getting Alison Campbell twice. Wow. That's yeah, I that's that's some some feat. So, yeah, well, you know, I, I actually became a a fertility doctor by accident in oh gosh, in the late eighties when I was a trainee registrar.

It was tradition then that. Once you've done your basic training, you spent a bit of time specializing and, and I felt the need, having been trained in and around Liverpool, we always had to spend, felt the need to spend some time in London. So, I applied for any job that was going in London and there was a gynecological ultrasound post at King's College and I went down there for the interview, and all the, in those days, it was all very sort of, basic, all the candidates sat outside, we went in one after another we came out and sat outside, and the door would open after a period of time, and the professor would come out and call one name, and And the rest of us would go home.

On this particular occasion we, we all went in and had our interviews and my name wasn't called out. However an elderly gentleman came out and said, Dr. Kingsland you were, you were not successful this time, we gave the job to the local candidate, but I I have a research fellowship coming up in a couple of weeks time, would you be interested in, in my research fellowship?

And I said, well, yeah, I would, but who are you? And the guy was Professor Howard Jacobs I didn't know at the time, but he's a world renowned reproductive endocrinologist. Reproductive endocrinology is basically reproductive hormones. And so I, I took the job and part of my role, I, I joined a world class team of, of researchers and part of my role was to look into a particular hormone and its role in IVF, IVF with Just taken off then, the first IVF baby was, was just about 10 years old.

There were only about three or four IVF units in the country, but I was asked to go and train for a period of time at Bourne Hall, and Bourne Hall was going through a transition. Patrick Steptoe, the founder, the guy, the ecologist, had recently died, and Robert Edwards was now On his own, the first set of researchers that had moved off ironically one of those junior doctor, junior doctor.

Scientist at the time was a chap called Simon Fishel, who went on to found CARE, for whom I work with now and his lead embryologist was Robert Edwards, who was to anybody who knows about IVF, was the founder, the first, he was the, the, the founding scientist who, who was responsible for the birth of the first IVF baby in the world, Louise Brown.

And I didn't realize at the time what an amazing opportunity was for me because we'd be there seeing patients, he'd be in the laboratory, I'd be doing the gynecological bit, collecting eggs, and in those days it was a bit like the Wild West, you know, we, we finding eggs, human eggs was, was no mean feat and we'd be there in the laboratory and I would send over the the fluid from from the patient's ovary and Robert Edwards would be looking for the looking for the eggs and he'd say no egg no egg got granulosa cells great and then I'd send over some more fluid and he'd shout I've got the egg I've got the egg and he'd come out and he literally you Wave his arms around him.

The thing that I remember about Robert was that he was Incredibly enthusiastic, but not only that and as you know, he went on to win the Nobel Prize He had, like many Nobel Prize winners that I've met over the last 40 years, this incredible ability to make his Subject appear not only really interesting, but very straightforward and simple.

That was a mantra that I've taken with me over the last 40 years that, and it just serves to, to to underpin the fact that what we do now in IVF is actually not that complicated. It's, you know, it has this aura and mystique about it, which in fact we have been partly responsible for creating that ourselves.

The first IVF baby was born in the UK. In Oldham, which is a little town outside Manchester, the reason why The baby was born in Oldham was that Patrick Steptoe, the gynecologist was a guy, was a consultant in Oldham and he'd learned, he'd gone over in the early 60s to, to America and learned a technique called laparoscopy and it was where a telescope would put it, you could put a telescope into your abdomen and see the contents of the abdomen.

Really like through a little tiny keyhole and Robert Edwards heard about this guy and recognized that this was the way that you could collect eggs. Before that, the only way you could collect human eggs was to make a cut in the in the patient's abdomen, but now using laparoscopy, you could actually do it through a keyhole.

So Robert Edwards and Patrick Steptoe met and Edwards took his laboratory up to Oldham, where Steptoe worked, and that's where the final experiments were done on humans, and it was actually The 106th patient that they, that they did IVF on that got pregnant, that woman was Carol Brown now when the first baby was born in 1978, there was a huge outcry from the National Health Service about this great new world, babies being grown in test tubes, to the point that the, the two of them were actually made to leave the National Health Service in Britain.

The demand had been created, so they moved and bought an old Jaffa Beat Hall, which was 15 miles from Robert Edwards Laboratory in Cambridge, and that was the start of Bourne Hall, the world's first IVF unit. But, that, that where it cre that was where the first myths were created about IVF, because it was shunned, the divided opinion, everybody has an opinion on fertility treatment and it was, it, it divided opinion amongst the population.

The National Health Service was just not ready for this concept of growing babies. In test tubes, and so the, it, it had to grow up in the private sector and patients had to pay for their treatment because the NHS wouldn't recognize or wouldn't mandate insurance for it. And it was only in the early to mid 80s when the National Health Service started Buy IVF back.

Firstly at King's College Hospital in London, then in Manchester, and then two or three years later, I left London and moved back to Liverpool, and that's where I started my first IVF unit. I had this idea though, this strong commitment that IVF should be available on the National Health Service. So I lobbied healthcare, I lobbied patients and worked have together with the, with the patient support group and my nursing and staffy scientific colleagues.

We managed to get funding for the National Health Services IVF treatments, so that I was very proud of the fact that anybody was under the age of 35. Who, um, had a body mass index under 30, who nobody on the planet called mummy or daddy. They were entitled to two attempts at IVF on the National Health Service.

And it was and we grew. The first year we did 90 cycles. And then in we grew to 200, 300, and when I left the National Health Service in 2017, the Hewitt Center was, which was the, the unit where, that I founded. was the largest unit in, in the UK offering NHS treatment and we were doing about 3,000 cycles and around Liverpool.

And that, at that point I felt that it was time for a change and that's when I joined Care Fertility, which were, which are the largest independent group within the United Kingdom. And we have about 15, I think it's 15 laboratories, 25 facilities. Clinics, and we do about 12,000 cycles of IVF, of which about 35 percent is funded by the National Health Service.

[00:12:50] Griffin Jones: So from public to private to back to some public. From a few cycles in the era of the idea of test tube babies to 12,000 cycles a year, one of the things that you said was that, well, it turns out it's not that complicated, but you also said that it's no easy feat to find an egg, so reconcile those two notions for me.

[00:13:20] Professor Charles Kingsland: In the early years we, we, we could only collect eggs through laparoscopy, so it needed an operation and a general anesthetic for the woman. Collecting sperm was a lot easier and techniques have not changed for collecting sperm over the last 20, 30, 40 thousand years. But one of the great breakthroughs in, in IVF was the advent of ultrasound.

This is where you could, you could put ultrasound waves through an abdomen and you could see ultrasonically where the ovaries were. And therefore, By guided ultrasound, you could then put a needle through the abdomen without recourse to an operation, and then put it straight under ultrasound guidance into the ovary.

Now, in the early days, we could only do it through the abdomen, and you could only ultrasound waves. So the patient needed a full bladder, and we would sedate the patient and put the needle into her abdomen, in through the front of the bladder, out of the back of the bladder, and into the ovary. Now, that was quite un, un, it could be quite unpleasant and painful although we did, we did most of those procedures.

Under local anesthetic, so they were tolerated, but it was, it was a bit Heath Robinson, and then in the early to mid 1980s, we developed vaginal sound, so that you, instead of putting the abdomen, the probe onto the abdomen, you could put it Transvagina, into the vagina and get a very, very close look at the ovaries, which are actually just on top of the vagina.

So you could, so you could actually put a needle, a very fine needle, through the top of the vagina and straight into the ovary, which made seeing the ovaries and collecting eggs from the ovaries infinitely more easy. And now the vast majority of All patients will have their eggs collected transvaginally and it only takes about 10 minutes to do.

It can be done quite successfully under general anesthetic, under local anesthetic. Very few times do you need a general anesthetic. Takes about 10 minutes, patient has a cup of tea and then goes home. And it's so it's, so really the technique of collecting eggs has not changed.

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There will always be a time and place for fresh egg donation, but frozen egg donation makes the fertility treatment process more efficient, more affordable, and less wasteful overall. This message has been provided by Asian Egg Bank. Discover the benefits of frozen egg donation from Asian Egg Bank. Visit AsianEggBank.com/for-professionals. To learn more, that's AsianEggBank.com/for-professionals. I didn't realize that it wasn't, that retrievals weren't done transvaginally in the beginning. I didn't know that. And Oh, gosh, no. So, of all of these changes over the years, what is your view of evidence-based medicine and seeing some techniques develop that have likely been positive, but as you mentioned, there are some other things, like perhaps the technique of retrieval, that have changed very, very little.

So what Yeah. Are you seeing has been the fruit of evidence based medicine, and what do you see creeping in that you don't feel is supported by the evidence? Evidence based medicine 

[00:17:56] Professor Charles Kingsland: is a, is a concept of the 90s, 90, the 90s. It was developed it was first described in the early 90s. 

[00:18:03] Griffin Jones: What were people talking about before the 90s?

[00:18:08] Professor Charles Kingsland: Well, you see this is the thing that actually makes me smile about evidence-based medicine. The, i, the concept of evidence-based medicine is that, that you provide a treatment or a therapy which is of unequivocal benefit to the patient. Okay? So, for example. An enlightened patient should say to the doctor or nurse who's prescribing medication for her, what scientific evidence have you got that this is unequivocally going to do me good?

So if I said to a patient who wants to get a, who wants to get pregnant, take your folic acid, for example. She could then say to me, well, what evidence have you got that this is going to do me good? Well, I could lead her to the library and show her I have unequivocal, scientifically proven facts that if you take folic acid you've got a better chance of having a healthy baby than if you don't take it.

Same with smoking, stop smoking. Why do you want me to stop smoking, Doctor? Well, I have unequivocal scientific Scientifically proven evidence that if you stop smoking, you have a better chance of getting pregnant. Oh, but my next door neighbor, she smokes 60 cigarettes a day and she's got five children.

Well, that doesn't matter because she may have a higher fertility to start off with, but her fertility has been damaged by smoking. But the thing is, I have had many contracts from many hospitals and never Have I been asked, as a doctor, to do the patient, to do a patient good? In fact, when we get, when we get when we qualify medical school, we have to sign something called the Hippocratic Oath, named after the Greek medic Hippocrates.

And the first rule of medicine is number one, don't do any harm, okay? So I'm okay, I'm in the clear, as is any doctor, as long as we don't harm anybody. And that has been the basis of medicine throughout the ages. So before evidence based medicine, obviously we had, there were therapies that were of benefit, but not many.

And most of, most of medicine was based on Non evidence based, myths, legends, suppositions stories, and why is that? Because, you know, humans love a good story. We love a good legend. I mean, I'm from Nottingham. For me, Robin Hood was one of, he's one of my heroes. I have no evidence that he ever existed.

He wasn't particularly harmful. And even nowadays, most of our medicine that we do is based. on legend. So, for example let's take acupuncture. If, if an acupuncturist said to me, if I went in with a bad back I'm going to put the, this is a, this is a scientific procedure, and I'm going to stick needles in your back, and it's going to make you better.

Or if it's going to improve your sperm count, if I want to, well, that's not true. Because there's no evidence to suggest that that's of any benefit. However, if the acupuncturist said, look, you know, there's very little scientific evidence that this is going to unequivocally improve things. However, it won't harm you.

It may make you feel a bit better, it may make you feel as though it's benefiting you, and in the whole scheme of things, that's fine. So you walk into, you know, I, I can remember just recently walking down fifth Avenue, walking into a, a herbal shop. And there's, there's, there's shells full of all these herbs, vitamins and minerals, and purporting to do this, that and the other.

But there's no evidence to suggest. That they, you know, by taking alpha, beta, gamma, glutamyl, placental transferase, it's going to improve your chance of having a baby. If you, if you're taking something that is non evidence based and you happen to get pregnant in my specialty, the IVF. Like for example, I don't know vitamin D or oxycodone 10, you know, or some medication and, or you're getting pregnant, you're desperate to get pregnant and you have reflexology.

And then you get pregnant. That is called coincidence. It's not cause and effect, it's coincidence. It's a happy coincidence, and, but there's no scientific, you know, I can remember patient said to me once. Oh, no, he went on, on the internet and said, Professor Kingsland has magical powers. We only saw him once.

We've been trying for a baby for five years. We only saw him once, and I'm now three months pregnant. I'll take that all day long. I'll take it all day long. But that is coincidence. She was gonna get pregnant anyway. And Voltaire said The best doctors are those who intervene when nature was going to take, was going to cure the patient.

That's the, that's the, one of the skills of being a doctor. We've taken it to the nth degree. Now I, I think evidence based medicine is the best. is great. Well, wouldn't 

[00:23:34] Griffin Jones: the lack of evidence, Charles, then be evidence to the contrary, almost? So you talked about the herbal shop. Well, if it seems that in an era of evidence-based medicine, that if they don't have evidence for it means that, well, why didn't they run randomized controlled trials or, or, because it either means they did and it didn't work.

They didn't produce any conclusive results, or they didn't, and then the question is, well, why didn't they? So, in an era of evidence-based medicine, is not having evidence, evidence to the contrary? 

[00:24:10] Professor Charles Kingsland: Well, yeah, but in medicine, and in IVF or fertility, in particular, particularly in the UK, we are very heavily regulated.

The practice of medicine is heavily regulated, which is not the same in many other areas. Spheres of, of of pharmaceuticals or or food products. So, if you often look I remember, you know, sometimes you're driving home from work and you'll, you'll be in a traffic jam and there'll be a bus in, in Liverpool and I'll be on, on the back of the bus, there'll be an advert and there'll be this, this you know, bright tooth, glowing guy, good looking fellow and he'll say, are you tired?

Are you listless? You need Ferro Biotin F, and you'll go, I'll look at that thinking, yeah, I'm tired, I'm listless, I need some of that, I want to look like you, and then if you drive a little bit closer to the bus, it'll say, 75 of 89 patients who were asked, Said they felt better. Well that actually means nothing.

It doesn't mean a thing. You might as well leave it alone. However, anybody who doesn't know about statistics will, will Well, they'd think, well, you know, if it's good enough for those 79 patients, it's good enough for me. Now, in medicine, if I said, oh, you want to take my fertility mint, for example because I've done a trial and 75 of 90 patients improved their sperm count.

That's, that is a, Poorly conducted, non regulated, non statistically significant trial, which I would be pilloried for, but though in other areas, that's fine. I mean, you know, during COVID here's me a professor. I, I, I remember there's a stage of IVF where we have to put embryos back. It's called, we create the embryo, back into the uterus.

an embryo transfer. And it's a very straightforward procedure, takes about 10 minutes. There is a technique, some people do it better than others but most people can do, do well. Now, one of the things many years ago it was the 31st of August, 1997 I think it was, it was a Sunday morning, and I did 8 embryo transfers on that Sunday morning, and all 8 patients got pregnant, and I went home that morning and switched the television on, And Lady Diana had been killed in a car crash.

And ever since that day, one of the things that I do to patients when I put an embryo, trans do an embryo transfer, I say, now you must think what's happened in the news today That's significant because this is the day you'll get pregnant. And when you will say, I got pregnant on the day that, and if I can't find a piece of news.

I get anxious. Similarly, I have to shake everybody's hand in that theater. So I shake the nurse's hand, the embryologist's hand, the patient's hand, and the patient's partner's hand. Because if I do not shake their hands, they're not going to get pregnant. Now, you cannot tell me that that is evidence based, but I, it's important.

Do you really do it though? 

[00:27:46] Griffin Jones: You've done it all these years? Oh yeah, yeah, yeah, still. Every transfer, every 

[00:27:50] Professor Charles Kingsland: retrieval? Every transfer you can, you, you can ask any of the scientists because I have a deep seated suspicion and there's, I don't think there's anything wrong with that. And this is one this is one of the facts where I, I think it's very important that we include non evidence based medicine.

into our treatments. What we have to do though, what we have a duty to do, is to advise the patient. This is not evidence based, there is no scientific data, however, this is the risks, these are the benefits, but importantly, These are the costs because I feel very strongly that you can financially harm a patient by offering them non evidence based medicine.

But, similarly, just in the same way that, you know, my wife will buy a handbag if she wants to feel better. If it's a health issue and you want to spend money on your health, Provided you are fully informed that this is a little evidence based base, as long as it's not harmful, then you're free to do whatever you want.

What you should be allowed, you know, free to do. I remember a few years ago I was working in Cares Clinic in London and I did an embryo transfer on a patient and she wanted some additional treatments to help her through. And I said, you don't need to do that. You don't need that. No, it's not gonna benefit you.

And she complained, and she said Professor, the complaint, the formal complaint was, Professor Kingsland wouldn't allow me to spend my money. I wanted to spend my money on my health. He told me what I could do, what I shouldn't do, but he didn't give me the choice. And I think that was a very salutary lesson for me, that, you know, if patients, you want to spend money on their health, provided they're informed about the risks to the benefits that should be allowed.

And we have this, I'm not, you know, in, in IVF, certainly in the UK, our regulatory authority, the Human Fertilization Embryology Authority, have a traffic light system for evidence-based medicine, and they have treatments which they regulate by, Saying that they're green, amber or red, green is unequivocal benefit evidence-based amber is the jury is out.

Neither benefit nor harm and red is, it is of no benefit or maybe harmful. Now, there are one or two things that that, that the HFEA have regulated, have. They are RED RATED and therefore it's bad medicine. I have to disagree because it shows a, you know, in many cases it shows a fundamental lack of the meds, medical process and how humans want to be treated.

And so And provided we are, obviously it shouldn't be harmful, it shouldn't be expensively harmful, but we should be allowed to choose, and if we want to use vitamins and minerals of a nature of doubtful benefit, or if we want to have acupuncture, or, or, or complementary therapy, that's absolute, if we want counseling, that's absolute.

That's absolutely fine, and that's where I think, just so happens, because money is involved with IVF, we seem to hit that interface harder than anywhere else, because, you know, there are, there are hospitals in, in the UK that are, that are Endorsed by the Royal Family, the Royal Homeopathic Hospital, the Royal Homeop Well, homeopathy, it's great for, for, for many people, many people strongly support and want to be treated by homeopathy.

And that's fine, but there's very little scientific evidence that it's of any benefit. 

[00:32:02] Griffin Jones: So I want to see if we can find a case for some of these things that are, are not harmful, but to, for, allow for medicine that isn't evidence based beyond the, beyond the idea of consumer freedom, beyond the positive association of other events that happened around the untimely death of positive monarchs.

Is there, is there another benefit to So, allowing for non evidence based medicine as long as it isn't harmful because there's something there about advan that that that the fringes of medicine advances. One example that you mentioned you you talked about, you know, Vitamin D and and there not being a A lot of evidence in that supporting fertility outcomes perhaps, but I have had an REI tell me that the number one thing that he recommends for men is vitamin D.

That for, for malvarility in the case of fertility, if you can lay outside under the sun with your testicles out. So this is a clinician that feels very strongly about vitamin D. Do you feel that That that it very, perhaps the evidence says that there isn't the evidence to support that. But is there something about having the the barriers to evidence based stay at At doing no harm, that allows the fringes of medicine to actually produce more evidence.

[00:33:36] Professor Charles Kingsland: Oh yeah, well that's the whole basis of, of progression, advance, advancing technologies and, and, and medical science. So using vitamin D as an example. There, I, there is a body of evidence now that suggests that vitamin D is more than a vitamin. It might, it may, it may have some enzymatic actions on health and general well being and fertility.

It's certainly not harmful, and there is some evidence, although it hasn't reached an evidence base, to appear in learned journals or learned textbooks, that you must take vitamin D. Vitamin D. I would not be as, as strongly supportive as vitamin D as as your your colleague, but there are There are, for example, firm, evidence based facts about improving your sperm count, you know, keeping your testicles cool, having a good diet, not taking not taking steroids, not smoking.

There was a time when we all, when we advocated vitamin E. Now, the basis of vitamin E and male virility and sperm counts was based on rat studies. If you feed vitamin E to rats, they go wild. And it, it improves, it increases their libido massively, and we extrapolated that to humans. But, vitamin E, again, is one of these things, that is not necessarily harmful, there is very little evidence to suggest taking vitamin E will unequivocally be a benefit.

Now, there are more recently, going back to your advancement of science and, and using fringe subjects and looking at them more critically, there is some evidence that vitamin, vitamin E actually might be harmful. in some patients. So going back to what you said I think it is really important that we take these fringe well I call them fringe loosely but complementary therapies or therapies that have not reached evidence based.

And look at them more critically, but subject them to scientific rigor, to the proper randomized trials, and then we can say, yes, they are a benefit, or no, they ain't a benefit, and that's it. Look elsewhere. 

[00:35:55] Griffin Jones: Delineate, for me, the difference between some evidence base versus being truly evidence base. So you mentioned there's some things that have a base of evidence, but that's not the same as being, like, really evidence based.

Is the difference RCTs, is it publications in journals? 

[00:36:13] Professor Charles Kingsland: Tell me about that. So, so we have, we have a grading of evidence. So we have grade A. B, C. Grade A evidence is evidence that has been created by randomized, prospective, well powered trials. So these are the highest quality clinical trials that you can do.

And they have reached a particular strength that you can say, these actually, we're, we're Our results and our facts smoking in pregnancy folic acid, which I've used as an example before. You have, then you have Grade B evidence. Grade B is the second tier of strength of evidence. This is where the evidence has been gathered, not necessarily by randomized prospective trials, but by retrospective trials trials that have looked back at Data that's already been created by case reports, by meta analyses where lots of retrospective trials have been put together with big numbers, and data Or, some say yes, it's better, some say no, but, but, it's, it's equivocal.

Grade C evidence is the poorest grade of evidence, and it's down to, you know, my Auntie Bessie took folic acid in, or she took vitamin B C and she got better that the, the, that that's the, the grade C evidence. And we, we actually in the UK publish NICE guidelines. Well, they used to be called nice.

They're now called NIHC, national Institute of Clinical Excellence. Looks at a particular subject in medicine. And we'll rigorously appraise that subject and give a list of recommendations based on grade A, B, and C evidence. So if you look at grade A evidence, for example in my specialty, fertility, ICSI, this is where a male has got poor sperm and it's, and so what we do, we, With, with his sperm, we will inject a single sperm into the egg as opposed to incubating the egg with a hundred thousand sperm.

Sometimes a male may not produce a hundred thousand. He may only produce four or five sperm. So we take one sperm and inject it into the egg. That is unequivocally of benefit. IVF, IVF works. If that, if that guy didn't have IVF, he wouldn't father a child. So that's the, that is grade A evidence. It's the strongest particular evidence you can get.

I'm trying to think of grade Bs. So, going back to acupuncture, that would be grade, that would be grade B. Some trials show its benefit, other trials don't show its benefit, but no trial will show it to be harmful. So these, they're, they're the sort of grades. And then, as I said before, provided you Get that information from your doctor or practitioner, then it's fine.

You're free to choose. The problem comes when you're, when you are subjected to huge fees for, for treatment that is not necessarily going to be of any benefit. And that is where the difficulty lies for patients. Just getting that, the information that they need to make an informed choice. Is the degree of harm, or the range of harm, is it relative, Charles?

[00:40:00] Griffin Jones: Let me give you an example to explain what I'm trying to ask here. There's a nephrologist in Toronto named Dr. Jason Fung who feels very strongly about prolonged fasting and its benefit in increasing longevity, in reducing chronic disease in decreasing the risk of amputation and decreasing the risk of other bad things that happen after amputation, particularly in diabetics.

But he admits that there's not a lot of randomized controls. It's hard to do randomized controls on anything having to do with longevity, for example, human longevity. Yeah. But There could also be some harm in prolonged fasting that you could bring back out for some people, there might be other complications that happen if you go on a six day fast, but I listened to him talk about that sort of protocol shortly before her.

An elderly relative of mine who was obese and had diabetes had an amputation and then died, you know, within a few months of that amputation. And I had thought about, after listening to that, telling this elderly relative, why don't you just not eat for four days and see what, and, and see what happens.

Now that could be harmful. It could be harmful. But if you're, If you're elderly, if you're at, if you have diabetes, if you're at these risk of certain things, what I'm asking is, is the range of harm relative based on the condition that, that someone is in? 

[00:41:40] Professor Charles Kingsland: Yeah, the range of harm is always relative. We talk about precision medicine.

This is another one of my Bugbears, you know, we, we have these fashions in medicine that come along and, and certain clinics will say, oh, we are advocates of precision medicine. Well, the implication is that the other clinics are not precise. The whole idea of medicine, it is a very precise, Specialty, but we can generalize to a certain extent, but there are some people where you have to individualize their risks and benefits of a particular therapy.

And this is a case in point, you know, the, the 70, 75 year old obese, diabetic may be safer on a a calorie restricting diet over a number of days. I certainly wouldn't, you know, a 20 year old who's growing and developing and needs all the protein they get and they need all the energy they get, well that's not so prevalent in a 70 or 80 year old.

So, it's horses for courses. A liver, one of my friends who's a liver transplant surgeon said to me, you know, it's like saying I'm an alcoholic and I'm not alcoholic. It's very difficult. Some people will damage their liver. with small doses of alcohol. Others could drink bucket loads of the stuff and not get a, you know, not, not get any damage whatsoever.

And it's, it's who you are that counts, not not where you go. I often say this about you know, success rates in fertility clinics. In my experience over 40 years, The vast majority of fertility clinics have very similar outcomes. Okay, there are some that are excellent and there are some that are not so good.

But the majority of clinics are pretty damn good. It's the same as, you know, in, in, I keep using the UK as an example. You know, you go, you go in with a, with a routine problem to a National Health Service hospital. You'll be okay. You know, you'll be fine. But there are, there, it's not where you go for your treatment.

It's who you are. And the skill of the clinician or the doctor or the fertility doctor, whatever your, whatever your disease or disability. Is, it's picking out who you are and what you need. Now, fortunately, the majority of us all fall into a, a basket. It doesn't matter what, you know, if you're a, if you've got a pain in your tummy and, and it looks like an appendix and you need an appendix operation, 90% of the time it will be absolutely routine.

But every so often there will be. A problem where, you know, which is usually predictable, and if you've predicted that problem, then it makes the outcome so much easier, and that is the, that is my point about individualizing your treatment and precision medicine. It's all, it should all be precision medicine.

It shouldn't we should all be treated as individuals, but most of the individuals will be, will, will come within a category of what we would say the normal range. 

[00:44:58] Griffin Jones: Speaking of where you are, you have practiced in the UK, you're now part of, you've been part of CARE Fertility for many years, served as their Chief Medical Officer, you're doing a lot of advising now, but CARE has expanded I know into the U.S., into North Carolina, presumably planning further expansion in the U. S. Do you all have a presence on continental Europe as well, or just U. K. and Ireland? 

[00:45:21] Professor Charles Kingsland: We now have clinics in Spain as well, so we have clinics in U. K., U Spain, and now the U. S. How did the schools of thought 

[00:45:30] Griffin Jones: on evidence-based medicine differ between the U.K. and continental Europe and the United States? For more UN videos visit www.un.org 

[00:45:38] Professor Charles Kingsland: Very similar. We're, we're, we're all very similar. The, the, the, the, the ma the majority of the medicine is, the vast majority of the medicine is very similar. And just using fertility therapy as a, as a, as an example is formulaic.

Most of it is, is the same wherever you go. The way that it differs is, is in how it's how it's perceived. In the US, for example, you know, it, it is most of the clinics are owned by private equity, is far more business orientated, and the doctors need far more business acumen, I would say, than doctors, equivalent doctors in the UK, who have, who have had a far more well, governmental NHS education, so for example, in the u uk a in the US a clinic has to be owned by a doctor.

You cannot practice IVF fertility therapy in the UK, in, in the US in a clinic that is not owned by a doctor, whereas that's just not the case in Spain. Or or the UK, but the way that the clinics are run in terms of the medicine, they are very, very similar. Most of it is, as I say, formulaic and irrespective of, of where you go whether it be, you know, Uh, you know, Boston or San Francisco or Carolina or Texas.

For, for the standard patient, the outcomes are the same. It's only when you are out of that standard, you're, you know, out of the normal range where your chances of success are probably different in different clinics. But you will experience. You know, it's the duty of any practitioner, healthcare practitioner to be able to pick out the good prognosis patients, the less good prognosis patients, and manage them or refer them on accordingly.

[00:47:54] Griffin Jones: I want to ask you about your views on the REI's role in in top of license, what the REI needs to do versus what Other practitioners, either generalists trained OB-GYNs or even advanced practice providers or nurses should be able to do, but I know that's, that's gonna have to save for another day. I'm gonna have to invite you back on for that.

I want to give you the concluding floor of how you'd like to conclude about what it's been like. over the years to see this sort of development, to see this focus on evidence-based medicine, the changes that you've seen in the field from the days of what it was like to work with Dr. Edwards, that is.

I'll let you conclude how you see fit. 

[00:48:45] Professor Charles Kingsland: The biggest breakthroughs that have occurred in the last 30, 40 years are in the laboratory, without question. What when we started we, we weren't able to assess embryos very well. We weren't able to grow embryos very well. We used to have to put embryos back when they were 48 hours old, because we didn't have the, the culture media, the complexity of the culture medium to have, to be able to grow embryos.

To three, four, five days. And because we couldn't grade embryos, we used to put more than one back in the hope that the more embryos you put back, the better chance you had of achieving a pregnancy. The risk of course, was multiple pregnancy. And although couples who have been desperate for a baby for years would like to have the thought of having twins and triplets, for OB-GYN it's a nightmare because for every healthy set of twins that are pregnant, Being pushed around the local supermarket, patients don't see the dead dying or miscarried twins.

So nowadays we grow embryos. We can assess embryos very well. We grow them up to five days old and we only have to pull one back. So have as many bees as you want, as long as it's wanted at a time. So they're the big advances as far as the gynecology is concerned. Very little has changed. There are things that come along every five years that alter how we practice medicine.

But what we have to do is to deliver the best quality egg and the best quality sperm we can to the laboratory. And then hopefully get a, a good embryo and a good result at the end. The big issue that we still have is accessibility and scalability in IBF. Only the WHO recently published a paper that only 2 percent of the population in the world that needs Fertility therapy can have, get access to it because the, the rate limiting step is access to fertility units and then once you're in the, in the fertility unit, it's, The scalability, we can only do so many with the manpower.

So I think that we have, so I think the future, the next generation, we are going to be looking at robotics, artificial inseminate artificial intelligence, which is going to, you know, We have revolutionized the way we deliver IVF, and I think at this particular stage, we're at that level of technology when accessibility and scalability is going to is going to come to the fore, and that is an exciting time, and that's why I'm still going, because the end product is, you know, the The job satisfaction that I get is like unsurpassed to see couples who, who achieve a parenthood after many years of lack of success is, it's so rewarding.

I don't tell Kev, but I do, I do this for nothing now as a hobby because it's, it, it is. And so I, I just see the next, you know, five, 10 years as being a real revolution. in IVF Scalability, Accessibility, AI. Robotics, it's, it's gonna be, it's gonna be great, it's gonna be great, and so that's what I would and it's gonna be not only great for, for our specialty, it's gonna be great for patients and, and great for the population.

[00:52:16] Griffin Jones: The next conversation I want to have with you is about that revolution and what standards of of evidence based or difference between the clinical care and for operations and engineering. That will have to be in the next conversation, but I am looking forward to having it already. It's been a pleasure to have you on the show, Charles.

I really look forward to having you back on the Inside Reproductive Health podcast. 

[00:52:39] Professor Charles Kingsland: Thanks a lot, Griffith. See you soon. 

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You might wanna start that relationship now if you haven't already. To learn more about Asian Egg Bank and the benefits of their frozen egg donation process, head to Asian Egg Bank. Dot com slash for dash professionals. That's asianeggbank.com/for-professionals. 

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