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If basking young mate down the pub about FAPE in hands, one, they probably say.

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No one agrees if it's safer on nuts, so you might as well smoke anyway.

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Now, watch your mate needs is a Cochrane review, all the facts have been checked at least twice.

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Think, find there's a lot that the experts agree on.

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I'd give you a. I'm Jamie, and I'm Nicola.

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Welcome to the first episode of our new podcast. Let's talk E-cigarettes.

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So back in 2013, Nicola and I applied to Cancer Research UK for funding to support our work on e-cigarettes.

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It was 2018. The world was in lockdown and everything felt like it was full of possibilities.

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So as part of that grant application, we proposed doing a podcast for people interested in e-cigarettes research.

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Now, here we are two years later in a slightly different setting than perhaps we'd originally imagined, but still trying to make this podcast work.

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So I'm talking to you from my kitchen in Oxford when a sleeping black Labrador.

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My feet. Still only a puppy. Not always the best behaved.

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So fingers crossed, he'll stay asleep for our first episode.

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And I'm speaking to you from my living room with a fluffy little cockapoo at my feet who is wide awake.

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So we're hoping that there's not going to be much barking involved in this first episode.

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The cockapoo seems to respond particularly to my voice. So there may well be a little bit of barking going on.

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So really what this podcast is here for is to tell you a bit about e-cigarettes.

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And the reason that we're doing this is because Nicholai both the research on e-cigarettes at the University of Oxford,

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and we do this as part of the coffee and tobacco addiction group.

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So just to give you a bit of background, Cochrane is a global non-profit organisation that exists to help people make health care decisions.

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And we do this by carrying out systematic reviews of the research literature.

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That means we identify and bring together all relevant studies is an area to find out how well something works,

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whether it causes any harms and how certain we can be if the findings. So Cochrane reviews are enormous documents and quite large undertakings,

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and they often feel like they're never finished because we update them relatively frequently.

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So we actually first published our Cochrane Review of Electronic Cigarettes for quitting smoking back in 2014,

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and we published an update this October. So in this October's update, we found 50 studies and I'll quickly let you know what we found.

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Just to give some context. So in our October update,

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we found evidence the nicotine e-cigarettes probably do help people to stop smoking for at least six months and not to do this.

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They probably work better than nicotine replacement therapy and nicotine free e-cigarettes.

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We also found they may work better than no support or behavioural support alone and that they may not be associated with serious unwanted effects.

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However, it was really clear, and this is a common refrain you hear in e-cigarettes research,

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that we need more reliable evidence in order to be confident about the effects of e-cigarettes.

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And that is particularly the case for the effects of newer types of e-cigarettes

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that have better nicotine delivery and also in terms of their long term effects.

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So for that reason, for the next couple of years, we're gonna be searching for new studies for this review monthly and updating

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the review whenever we find new studies that might change our conclusions. And we're doing this with support from Cancer Research UK.

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This kind of continually updated review is a lot of work, and it's called a living systematic review.

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So we chose to do a live in systematic review on this subject,

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in particular because of ongoing controversy about the public health impact to be cigarettes.

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And it's really important that decision makers have the most up to date evidence to hand in our review.

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We look at the use of e-cigarettes to help people who smoke to stop using cigarettes.

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And in this podcast will first quickly summarise the new studies that we found in our most recent monthly searches.

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And then what? We'll then pick an important new study to look into in more detail.

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So a deep dive into that study, as it were.

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So first off, we'll summarise the new studies we found in our searches this month, which were carried out on the 1st of December.

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We'll do this briefly.

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So you might say in a notch, say this month we found eleven ongoing studies, which are studies being carried out that don't have results yet.

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We found nine new papers reporting on studies that are already included in our review said these were studies that we already knew about.

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And we also found three brand new included studies. And we'll incorporate those studies in the next update of our review.

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So Jamie and I are now going to give some information on each of these.

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And you can also find links to these studies in the description of this month's podcast.

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So amazing naglaa. Just first off to say how excited it is to see eleven new ongoing studies.

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I've obviously been looking at the research in this field for quite a while.

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And by contrast, between 2014 and 2016, we only saw 14 new included studies.

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Now we're seeing 11 over a period of 10 months.

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So that's great and suggests that we are going to be getting more research in this area to put into our view, which is exactly what we need.

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So of those three new studies we found, the first one was a study was published in the journal Nicotine and Tobacco Research,

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and it was a study led by Chorley and colleagues truly spelt C, z, o l i.

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It was a Canadian study with 48 participants, and it was funded by the Ontario Ministry of Health.

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And also by the Canadian Institutes of Health Research. So basically by government agencies.

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And that's important. We always want to look and see where studies are funded from.

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And we tend to trust those funded by the government or health care organisations more than we might trust those funded by,

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for example, the tobacco industry or the cigarette industry. So this Canadian study had 48 participants and it looked at relatively short outcomes.

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It was primarily interested in the phenomenon of dual use, which means smoking and using an e-cigarettes.

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At the same time, they used a overdesign. So that means rather than like in a randomised controlled trial, having, let's say,

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two groups of people and assigning them to e-cigarettes or not to e-cigarettes, all participants experienced each of the conditions in the study.

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So all participants spent a week using both e-cigarettes and smoking Duell, using, as it were,

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a week using just e-cigarettes, a week just smoking and a week using neither device.

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And in this study, they measured product use.

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So how many e-cigarettes people used, how many cigarettes people smoked during these periods and also what they called biomarkers of exposure?

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So those basically measure exposure to things that aren't very good for you.

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And in this case, that includes carbon monoxide and various other toxins.

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And you'll have to bear with me as I try to pronounce some of these toxins.

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Would I tell you about what they found?

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So they found that levels of biomarkers of exposure to toxicants, including carbon monoxide, one hydroxide, PIJ rain and four methyl nitro semino.

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One three paradiddle. One butanol, which is snappy.

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Your name is an NHL, were significantly lower when participants exclusively vaped compared to when they were dual use in.

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So when they were vaping and using cigarettes and as you would expect,

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they also found that toxin levels were lower in people who weren't vaping or smoking compared to people vaping and smoking at the same time.

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Now, interestingly,

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they also found that levels of toxins were higher when people were only using cigarettes compared to when they were smoking and using e-cigarettes.

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So compared to DOOL using. And the reason why that's interesting is it doesn't really support some commonly voiced concerns.

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We hear about possible harms of dual use, increasing toxin exposure compared to just smoking.

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Great. Thank you, Jamie. And were all poor listeners are missing out on is how Jamie's eyebrows,

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why up and down when she tries to get the name of those biomarkers, which I'm very much enjoying?

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Laughter I'm glad you are of to think of a video for my next summer.

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So the new included study that I had a look at is called the Quick Nicks Study and was also published in the Journal of Nicotine and Tobacco Research.

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It was carried out by researchers at the University of Newcastle in Australia and led by Professor Billy BNF Escape.

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And it was funded by the Victorian Health Promotion Foundation, which receives its funding from the government.

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So this one was actually a feasibility trial.

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So the aim is a feasibility trial is generally to test whether the trial or the treatments given in the trial can be carried out on a practical level.

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And to see whether it will actually be possible to carry out a larger trial.

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And the reason for this is that it can avoid wasting a lot of time and resource,

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which might happen if you immediately carry out a larger trial and you find that things don't work out as you expected.

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Therefore, these trials often have sure to follow ups unless participants in full scale trials.

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And this means we do need to be a bit more careful about how we draw conclusions from them than larger long term trials, said the Quit.

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Nick trial included one hundred people who smoked,

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who were recruited from a residential drug and alcohol withdrawal service where the average length of stays eight days.

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The sign is a smoke free site and all the clients are offered. Nicotine replacement therapy is standard jeering this day.

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The 100 people who were taking. In this study were randomly assigned to two treatment groups.

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One of the groups were given twelve weeks worth of nicotine replacement therapy,

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including patches and oral forms of nicotine replacement therapy, such as gum.

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Following discharge from the clinic and the second group were provided with an electronic cigarettes starter kit,

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which included the inner skin Indira T 22 device, which has a one point five Omma atomiser and a 4.5 millilitre tank.

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And they were also provided with a 12 week supply of one flavoured nicotine equipped.

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And then both of the groups actually received Talison based Quitline support.

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So their 12 week follow up. They didn't find a significant difference in quit rates between the two groups.

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However, we do need to be very careful about how we interpret this result due to the small number of participants.

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And actually we won't be including this in our meta analysis of smoking cessation results,

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because in amateur analysis, we only included results that results from a six month or more follow up.

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And because this was a short Herland study, we weren't including it.

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And we're hoping to maybe in a future podcast at Splaine a bit about our

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reasoning behind that in terms of potential harmful effects of the treatments.

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That is something that we'll be looking at in our review. And what this study found was that there were no adverse events or serious adverse events

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which were classified as probably or definitely caused by any of the study products,

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said that was both the nicotine replacement therapy and the electronic cigarettes.

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Great. Thanks, Nicola. I am looking forward to incorporate in that study into our main review and

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also hopefully to see in that study progressed to a full trial at some point.

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And now we mentioned there are three studies. You've heard about two of them.

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But for the third one, you'll have to hang on until the next section to hear about it.

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So you'll have to hang on until our deep dive. This bit was pre-recorded at an earlier date.

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So as we mentioned earlier, each episode,

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we are going to select at least one study from the illegible studies identified from the most recent literature searches to take a closer look at,

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say, for this month's deep dive. We've chosen to focus on a new randomised controlled trial led by Professor Mark

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Eisenberg at McGill University in Canada and published in JAMA in November.

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So I was lucky enough to speak to Professor Mark Eisenberg lead of this trial about this earlier this month.

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It was the first time I'd ever been the interviewer on a podcast as opposed to the person being interviewed.

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So it was a new experience and I am super grateful to Professor Eisenberg who gave us such useful insights.

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So to start off with, will that Professor Eisenberg tell you a bit about his background and how he came to lead this trial?

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My name is Mark Eisenberg.

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I'm a professor of medicine at McGill University, Montreal, Quebec, Canada, also a cardiologist at the Jewish General Hospital at McGill.

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So this Emma and I'm a cardiologist and I'm an interventional cardiologist,

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so I do angioplasty to open up arteries for people that are having heart attacks.

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And I noticed two years ago that a lot of the patients that they had heart attacks.

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Now we give them a routine set of medications.

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We give them aspirin, we give them a statin for the cholesterol, get beta blocker and his inhibitor, and we give them an antiplatelet agent.

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And I thought, you know, a lot of my patients, least a quarter of them are active smokers.

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And if I can give them a pill at the same time when they came in hospital, that would give them to stop smoking,

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I would do as much good as, you know, giving them an aspirin or a cholesterol medication.

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So I started getting interested in smoking cessation.

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I did a series of trials in patients that had heart attacks, starting them with the medication in hospital to see if I could get them to stop smoking.

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So I did a trial with would be appropriate in the trial of Varenicline.

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And then, you know, during the vertical trial, that's when the e-cigarettes started to come out.

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I thought, wow, this is a potential sea change for smoking cessation because they had a number of patients came to me and said,

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you know, I've tried everything for smoking cessation. Nothing worked. And then I picked up any cigarette and I never smoked again.

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So I said, you know, I think this would be something that we should study for smoking cessation.

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Does it work? Is it safe? And so we put in a grant application to the Canadian Institutes of Health research years ago.

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And when we first sent it in. It got rejected. They said, what's in e-cigarettes?

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Nobody smokes anymore. This is not important. What is this?

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And then you cigarettes were in the newspaper and the media, you know, every day for a year we resubmitted our application.

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I think it came in first amongst 663 applications because, you know,

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the importance of it was recognised because everybody was using them and nothing was really known about them.

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So that was the background for a trial. So I hope you enjoy that.

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I love hearing about how people got involved in this line of research.

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Yeah. And I think what Professor Eisenberg is saying is something that we hear a lot from people,

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that the drive for doing research in this area often comes from people who have switched from smoking to using e-cigarettes.

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And that's that's spurring researchers in the community to pursue that as an area of study.

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You're absolutely right. That's one of the reasons why I really like doing research in this area, feels quite different from research.

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And pharmacotherapy is where often it's driven by a company here.

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Actually, what we're seeing as a whole research movement, that's in quite a considerable way being driven by the people who the research that effects.

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So when I was talking to Professor Eisenbach, he went on to talk a bit about the design of a study and what he found and what he thought were

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the most important take home messages from that summit to let him tell you about that as well.

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Well, first of all, this study, as it was its previous studies, was done in and not in patients.

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They were just regular smokers in the community and they were recruited by word of mouth, by social media, by flyers.

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And we randomised them to three different groups to e-cigarettes with nicotine, identical e-cigarettes without nicotine or to counselling.

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All three groups got counselling, but the counselling counselling alone not only had counselling.

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And we. The intention was to this is done in 17 sites in Canada, across Canada.

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And if the intention was to look at smoking cessation of one year, we give them e-cigarettes only for only for three months or for 12 weeks.

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So the idea was short term use of e-cigarettes. Would this lead to smoking cessation at one year?

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But we got most of the way through the trial and we had difficulty obtaining a final supply of e-cigarettes.

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And ultimately, we had to stop enrolment early. And so in conjunction with the data and Safety Monitoring Board,

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we changed the primary endpoint from smoking cessation at one year to smoking cessation rates in 12 weeks.

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When you know the just at the time before. Before the participants stop their e-cigarettes.

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So what we found was that if you got an easier nicotine, you you little over doubled your quit rate at twelve weeks compared to concern alone.

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And that there was there was there was a high rate of quit rates,

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even amongst people that got e-cigarettes without nicotine didn't reach statistical significance.

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Twelve weeks quit. It was, it was more than counselling alone.

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These, you know, these results we just recently reported these results in the journal American Medical Association with a six month follow up.

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And the cigarette quit rates were no longer significant in six months.

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And surprisingly, the cigarette quit rates without nicotine work were significant at six months.

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So I think that, you know, because we started trial early,

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we only had about three quarters of the participants that we wanted to know that we really had the power to look at the six month results.

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But I think the results show pretty clearly that if you are,

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you are smoking a cigarette with nicotine while you're actively using it, you have a higher quit rate than if.

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And then if you didn't. And it also showed that if you were still smoking using any cigarette with nicotine,

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you substantially reduce the number of cigarettes you were smoking, conventional cigarettes.

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OK. Now, I should say that the quit rates amongst those those subjects who got counselling alone or it was

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a little under 10 percent and the quit rates amongst those who got e-cigarettes with nicotine,

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it's 12 weeks is a little over 20 percent. So a double quit rates, but it's only from about 10 to 20 percent.

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And that's somewhat similar to what we see with other therapies like your programme Varenicline.

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They double quit rates, but still the vast majority of smokers are still smoking. OK.

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So this is not a magic bullet for smoking cessation. On the other hand,

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it does appear that the for for certain individuals who have tried other other therapies and have been unsuccessful at smoking smoking cessation,

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that e-cigarettes do work should say that I think 90 percent of our participants have previously tried to quit several times,

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at least several times, and 80 percent of them had used other smoking cessation therapies before.

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These were people that had smoked for, I think, thirty five years on average and was smoking about a pack a day.

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You know, on average.

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So they were confirmed smokers who had previously tried to quit and we were able to show double quit rates compared to consent alone.

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So those were the primary primary results.

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That's really great to have those results summed up in that way by the person who actually carried out the study.

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And one thing that struck me from what you said is that only 20 percent of people quit in the most successful of the study.

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So that's really telling us that e-cigarettes caelum a magic bullet.

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So what do you think that really means for people trying to quit?

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Jamie? I think that's a really good point, Nick. I think within the field of smoking cessation research, that's a quote, right?

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We're kind of excited to see. Right.

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But relative to some treatment, there's some other areas of research, it seems like while only 20 percent of people successfully quit.

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Surely we can do better. An unfortunate reality is that though most people who smoke do want to quit, it can be really, really hard to do so.

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And as Professor Eisenberg mentions, a lot of people make lots of attempts before being successful.

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So. And we're looking at the success rates in a study of this type.

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What we're looking at is the success rates of one attempt to quit smoking, not whether or not that person will succeed eventually.

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And so I think it's important that people who want to quit smoking know that this is the case.

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They shouldn't be discouraged. Many people need to try to quit multiple times, but end up being successful.

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And even when we look at kind of the main front line smoking cessation medications, such as nicotine replacement therapy or varenicline,

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you still got relatively low quit rates, even in populations who are really motivated to quit smoking.

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And that doesn't mean these medications don't work. Smoking is uniquely deadly.

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It kills one in two regular smokers. So it's super important that anything that increases quit rates is available.

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But what these low quit rates mean overall is how much we still need more research on how to best support people in quitting.

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Absolutely. And that's why we're really excited to see this trial. Still, though, because of issues with conducting.

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It can't give us definitive results on those long term smoking cessation rates.

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So it does feel like there are a lot of hurdles to conducting research in this area.

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What do you think, Jamie? I think there absolutely are. I mean, it's not easy to set up a trial in any area.

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But I think there's some particular challenges when it comes to e-cigarettes. And as I've been reviewing the research in this field for six years now,

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I am always struck by essentially how long it takes to get these things off the ground.

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But also the evidence is coming. And it's always quite, I suppose, reassuring and exciting to see new trials coming out.

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And I wish they could come out a bit quicker. So I asked Professor Eisenbach to talk a bit about this.

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And what you'll hear next is that he had quite an interesting take on some of the unique challenges around doing research for these cigarettes.

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And I think some of those are driven by geographical contacts.

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And as we know, different countries have very different regulatory environments and public health messaging when it comes to e-cigarettes.

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So I'll let you guys listen to what he had to say about that.

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Oh, you know, look, it's it's shocking, really how little research has been done into e-cigarettes, considering how common use they are, you know,

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in North America and Europe across the world in the large part of this is because they're the cigarette companies have not sought approval,

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regulatory approval to use them for smoking cessation. And and so individuals picked them up in order to use them for smoking cessation.

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But the companies never claimed it for smoking cessation.

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They claim that their alternative methods of obtaining your nicotine and there's no reason for them to support research,

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either financially or to even provide e-cigarettes for for the research, because they're you know,

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they're selling, you know, millions and millions and millions of e-cigarettes.

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So it's really very little, you know, incentive for them to do that.

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At the same time, I think that the particularly in the US, there's been a reluctance to examine e-cigarettes for smoking cessation.

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And so there's been really a dearth of trials in this area when you can when you compare it to, you know, in cardiology,

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when you compare it to large cardiology trials that are driven by by pharma, you know, with tens of thousands of subjects.

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And there's you know, there's many, many trials coming out all the time.

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And you're looking there's only been really a handful of of well conducted clinical trials of these cigarettes.

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And and, you know, we have a you know, one of the issues, I think, with e-cigarettes is it's is a device, not just a drug.

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And whenever you use these devices are and always criticised saying, well, you used an old model, there's different models.

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No generalisable. It's not you know, it's not commercially available or was commercially available.

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But now everybody's using jewel. And so, you know, so you're never going to be able, you know,

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takes takes years to do these trials from the time that you conceived of the idea to actually get funding, to get regulatory approval to do it.

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So the by the by the time you actually publish it, you know, that device is no longer being used and you can be criticised on those grounds.

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So I think it's very, very difficult area to do research in.

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So the interesting thing is that despite this being such a difficult area in which to do research,

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I think there is really wide consensus that it's so important to have more studies and more data.

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Absolutely. I mean, I think those familiar with research in this field know that there is a whole lot to disagree about when it comes to e-cigarettes.

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But what I think everyone agrees on is that more research is needed.

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So even if you read systematic reviews or articles that find opposing things when it comes to e-cigarettes,

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they almost all end with directions for further research.

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So that actually brings me nicely onto the next question to ask Professor Eisenberg, which is really thinking about,

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OK, if these hurdles were in place, if we could do what we wanted around e-cigarettes research.

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What research does he think should be done next on the back of his study?

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Well, that's a good question. First of all, I think that we need many more studies on e-cigarettes.

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You know, my my father was a doctor and or whether I was a medical school and read an article in the New England Journal about some new drug.

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And I said, I think you should put all your patients on this drug.

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He said, I like to see 10 different studies in 10 different patient populations with long term follow up before they started switching my patients.

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And I think it's the same thing with e-cigarettes. I mean,

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we really need to have multiple different studies using different devices in different populations for with a longer term follow up close look.

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You look at safety, different comparators. I think that, you know,

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our study was really very particular and that we we were only giving e-cigarettes

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for 12 weeks and then looking to see what the impact on longer terms quit rates.

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And I think that's that's probably, you know,

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not it's an incomplete snapshot because most individuals who pick up e-cigarettes use them for a long time.

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They use them for four years. Some of them never stop, which I, you know, I don't think is a good idea.

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I think they should be used as a if they're if they're used for smoking cessation, they should be used as a bridge to quitting altogether.

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But if we were to look at using e-cigarettes for a year, for example, I think we would expect to see quit rates higher than what we saw.

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I'd like to give short term use of cigarettes and then withdraw.

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Then we'll look at longer term quit rates is probably not giving them the device a fair shake.

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So I would like to see. I would like to see different devices, different and different populations.

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But the longer term use perhaps also using using combination therapy.

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And we did. We did. We haven't seen this, even though other smoking cessation trials of other Varenicline trials were varenicline versus placebo.

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You know, appropriate drug be appropriate versus placebo. Nicotine patch versus placebo.

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There are only a handful of trials, one of which, you know, I think was perhaps the best trial.

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You know, every demos the Eagles tried really.

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They finally did, you know, Verini plan versus B appropriate versus patch versus placebo in a thousand subjects.

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So, you know, a head to head trial or head to head to head trial, I think is, you know, is ideal in placebo controlled.

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But but, you know, you need, you know, major, major funding to do those kinds of trials.

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You have to have buy in from lots of different organisations. And it's very difficult even to get regulatory approval to even to do in Canada.

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Do you know, we had to get approval from Health Canada to to to do this trial.

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It took almost a year to get approval to do it. So a lot of hurdles.

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So basically what he's saying is we need the Eagles trial.

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But with e-cigarettes rolled in. But until we get that trial, do you think that smaller studies can tell us anything?

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Yes, absolutely. So it can be really hard to run huge studies.

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They're incredibly time and resource intensive and smaller studies not only can be useful in their own right, but from our perspective,

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as people who bring all the evidence together, getting more studies is super important because it feeds into our meta analysis.

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So that's why we combine the results from across studies.

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And the more information we have in there, the more studies we have in there, even if individually the studies are small and don't find an effect,

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the more they help us understand how certain we can be about the effectiveness and safety of e-cigarettes for helping people quit smoking.

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So I think that just leaves it with me to say. Thanks so much, everyone, for listening and follow the link on our podcast page.

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Siddall latest on our Clocker view of electronic cigarettes for smoking cessation,

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depending on how our dogs, children and the global situation in the world procedes.

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Were hoping to post these podcast approximately monthly from here on in.

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So please subscribe. If you want to be alerted to the next one.

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In the meantime, we'll be incorporating findings from a study into our Cochrane Review and hoping to have an update out this spring.

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And we'll leave you with these closing words from Professor Eisenberg.

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We don't have long term studies, but most authorities would agree that they are much, much safer than conventional cigarettes.

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If you have a choice, your only choice is between smoking conventional cigarette and your cigarette.

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Thank you. Much better off smoking in e-cigarettes, but we clearly need large safety studies.

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And even those those have not been done right. So so this this area is begging to be studied.

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So really, I think, you know, and it's really it's got to be supported by funding agencies like the Canadian Institutes of Health Research or NIH,

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because the industry is just not going to do it. They have no incentive to do it in any way, even if you it were to do it there.

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They're considered to be tainted. Right. It's like you can't accept money from from a tobacco company to do cigarette research.

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Well, these cigarette companies are sort of the same. So we really would prefer to be at arm's length and maybe use their devices.

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You know, we purchase we purchased our e-cigarettes when all the funding came from the Canadian government.

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So I think that's probably the right way to do it. So thank you for that show.

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Going into our first episode of Let's Talk E-cigarettes.

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You've been listening to Nicole Anderson and Jamie Hartman Boyce with thanks to our guests this month, Professor Marc Eisenberg.

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The music you've heard is performed by Johnny Berlinguer,

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and it was co-written by myself and Johnny a couple years ago to perform on the streets of Oxford.

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We'd also like to thank Jonathan living some banks for running our monthly searches.

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Elsa Butler found it in this podcast and to all of our brilliant copper and co-authors for helping us sift through and interpret the literature,

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which is no small task. This podcast was made possible through funding from Cancer Research UK and through core infrastructure

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funding to the Corporate Tobacco Addiction Group from the National Institute for Health Research.

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The views expressed are those of Nicola and I,

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and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care.

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Theo. Smidgens of Fabin is safe and sound may help you.

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Yeah.

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But some mention the findings we have can tell us what happened long term, even though we know in his paper and than smoking remains still buying.