Voice-over: Welcome to Spotlight on Migraine, hosted by the Association of Migraine Disorders. Join us for fresh perspectives by medical experts and advocates as we explore the spectrum of migraine and dig deeper into this complex disease. This episode is brought to you in part by our generous sponsors, Amgen and Novartis.
Can probiotic supplements improve the lives of those with migraine disease? One study shows promising results. Stay with us as we dive into a discussion on the link between gut health and migraine in an interview with Samantha Stone, scientific medical liaison at ADM Protexin.
Since 2015, Amgen and Novartis have been working together to develop pioneering therapies in Alzheimer’s disease and migraine. Together, Amgen and Novartis share in a mission to fight migraine and the stereotypes and misconceptions surrounding this debilitating disease.
Molly O’Brien: Hello and welcome to Spotlight on Migraine. I’m Molly O’Brien. Today we’re talking about how improving your gut health could impact migraine. I’d like to say hello and welcome to Samantha Stone. She is a scientific medical liaison with ADM Protexin. Samantha, thank you so much for joining us.
Samantha Stone: It’s my pleasure. Thanks for having me.
Molly: I’m really excited about our conversation, but can you first tell us a little bit about your background?
Samantha: Yeah, sure. So I was in school for a very long time trying to hone my craft, focusing specifically on nutrition, the microbiome, food science. So I really worked a lot of my time in how what you consume or what you add to your body nutritionally can help to systemically impact inflammation and overall nutrition and digestion. So that’s a bit about my background, mainly in academia. But I’m working for ADM Protexin. I’ve been able to work on public-facing education as well as research in probiotics specifically.
Molly: Thank you so much for sharing a little bit about your background, and we do want to give a disclosure that ADM Protexin researches and manufactures probiotic supplements.
All right, so as we dive into our conversation about research in probiotic supplements and how they could impact migraine health, let’s start at the first step and talk a little bit about the gut microbiome. Can you kind of paint a picture for us about what’s happening on our insides and that whole world within us?
Samantha: Yeah, yeah, for sure. It’s definitely a hot topic these days. It impacts so much. Broadly speaking, there’s more than 50 to 100 trillion gut cells, so that’s just in your gut. That’s not even talking about what’s in your mouth, your skin, anywhere else. So that’s actually equal to or more than our bodies’ own cells, so you often are thought of as being made up of more bacteria than human cells in some cases.
This is a different mix per individual, so we might have a lot of the same strains or species. The amounts and numbers aren’t going to be the same even between you and I or you and your closest family member. There’s a beneficial mix as well as opportunistic pathogens, so those ones who in certain conditions can kind of take over and become a bit more dangerous, if you will, often leading to diseases, rashes, bad digestion, even migraines. They’re influenced by our early environment, so how you were born, brought up, as well as things like your diet.
So that’s a general overall picture of the gut microbiome, and one really interesting fact is that they actually work to function or strengthen the immune system. So amazingly, 70% of our immune cells are located in our GI tract. So you can think of that kind of as the first place where that initial insult or the kind of war heroes come out of. If you’re suffering from something, you start to realize how important that area is to the rest of the body.
Molly: Absolutely fascinating. So researchers are looking more and more into how the gut bacteria can impact our overall health, and even more so how gut bacteria can impact migraine. There was a new study recently published how the gut microbiome can impact migraine. Can you tell us a little bit about this recent study?
Samantha: Yeah, for sure. So I’ll just start off by giving a little bit of background as to why these areas could be a bit more connected, and it’s really that gut-brain axis, something else that’s become a hot topic in research and mainstream media these days. And the interesting thing is this is actually a bidirectional pathway, so signals that come from the brain can impact things happening in the gut and the same thing. Some of the interactions and hormones that can come from that gut bacteria can get fed back through and pass that blood-brain barrier, which starts to give you a bit of a sign as to how connected these areas are. So that’s kind of the premise for why a lot of these research topics are being undertaken.
So this one, specifically, was published in 2019. It did take place in Iran, but it really is the first of its kind. So it was the first randomized controlled trial. There was about 40 volunteers in each group, so there was an episodic and a chronic migraine group. They were between the ages of 18 to 60 years old, and these diagnoses were made by a neurologist, so it wasn’t just people coming in who have migraines, which is, of course, very important. But to make sure that everything was done by the books and able to be qualitatively assessed, it was diagnosed by a neurologist. So those who suffered from episodic migraines had less than 15 headache days per month, whereas those who fell into the chronic group had 15 headache days — or, more than 15 headache days per month.
So the primary outcome of this study was migraine frequency rate, the amount of time people suffer from migraines. Secondary outcomes, or things that they just looked at alongside, were quality of life measurements, so migraine severity, migraine duration; the other types of medicines being used, whether they were abortive — they stopped — or just preventative; as well as inflammation factors. So that’s just an overall picture of all the combinations of things that are being looked at in this study as well as the population.
So how did this study take place, right? What was the premise for it? So the treatment was two capsules of a probiotic or a placebo. So the probiotic was Bio-Kult Migréa. This is a multi-strain probiotic that contains 14 strains of live bacteria, so a whole combination of bacteria inside, at a concentration of about 2 billion per capsule. So besides these probiotic bacteria, there is also magnesium citrate inside, so about 45 mg per capsule, as well as vitamin B6, so that was about 4 mg per capsule. So that kind of gives you the idea of what the treatment group was taking versus a matched placebo pill.
And in terms of outcomes, the groups were split into episodic and chronic just to look at statistically significant differences between the groups and then comparing that to the placebo or control group.
So first off, that primary outcome of the frequency of migraine attacks. In the episodic group, there was actually a 40% decrease in the frequency of attacks compared to placebo. So that equates to a reduction — if they started off with about 7 migraine attacks recorded at baseline, that first initial visit, by the end of this trial, the end of 10-week intervention, they had a decrease to only about 3 attacks per month, so just imagine that quality of life.
If you compare that to the chronic group, they had an 8-week intervention, and their frequency of attacks decreased by 45% compared to placebo. So they reported a baseline attack of about 22 attacks initially, and that decreased to about 12 attacks per month. So in both the episodic and chronic groups, you saw about a 50% decrease in terms of frequency of attacks.
And then moving on to attack severity, in both the episodic and chronic groups, there was about a 30% decrease in the severity of the attacks. So while having a migraine is never enjoyable, even just having a small decrease in the ability to have that pain threshold decrease might allow someone to maybe get out of bed a bit earlier or finish reading that sentence of the chapter they’ve been reading for 3 weeks.
Moving on to the number of abortive medications, so traditional medications, the episodic group saw a decrease of about 35% of the amount of abortive medications they were taking compared to about 40% in the chronic group. So again, even just decreasing the amount of medications you have to take over time impacts your quality of life.
And lastly, the attack duration, so the amount of time that the migraine will go on for. In the episodic group, this was seen to decrease by about 15 minutes per attack, versus in the chronic group, nearly 35 minutes per attack, so halving that migraine in half.
So again, those are kind of the results that we’re seeing, and all of them were statistically and clinically significant compared to placebo. So not, again, saying that even having someone decrease a little bit of severity, it’s not statistically significant — it’s still significant to that person’s life, but in terms of the scientific research, having them statistically significant really shows an overall improvement compared to nothing or that placebo group.
Molly: I have to say, it’s pretty fascinating to see significant changes just from this study, but there have been similar studies too like this in the past. Can you tell us what makes this study different?
Samantha: Yeah, yeah, for sure. So initially, I had said that this was the first randomized control trial of this kind, so I think that in and of itself makes it a bit different. There was actually a systematic review that was published this year as well that was able to compare the studies that were out there. So they took all the studies using a search on scientific websites like PubMed or Web of Science, and there was about 67 or 70 studies that had been found.
By the time there’d be finished filtering things out, there was only two studies that fell into the realm of a randomized placebo-controlled trial that was able to have results that were worth looking at in terms of a large study size, great qualitative measurements. This Martami study was one of them. There was another one that was published in 2017; however, interestingly, that study did not see any improvements, whether they were clinically significant or not. So I think that, in and of itself, shows how significant and important this study can be.
There were a couple other clinical studies, one with about 40 patients as well as an open-label pilot study just to kind of see what was happening. Those did use probiotics as well as other herbs and vitamins, and they were able to see significant improvements. But again, it wasn’t the gold standard of the science realm, so no randomized control trials.
Molly: This study seems to show that taking probiotic supplements can improve the lives of both episodic and chronic migraine patients. What does a study like this mean for someone who has migraine?
Samantha: Yeah, I think it gives them just in and of itself another option. A lot of migraine patients will either stick on the same treatment or bounce around lots of different treatments. I’ve also heard from a lot of migraine patients that have gone to doctors that have — the doctor’s looked at them and said, “There’s nothing more that we can do for you.” So I think in and of itself, it just gives them another avenue to explore, as well as another conversation to have. Traditional treatments definitely have their place and work, but nothing says that there can’t be things that you can add in as well as try.
And even just thinking this a little differently, this Martami study saw a reduction in the frequency of migraines nearly, what, 2 1/2, 3 days per month compared to placebo? There was a recent Cochrane review — so that’s a review that looks critically at all the science that’s out there for certain conditions, so this one, specifically, would be migraines — and there was a review looking at topiramate — so that’s a drug currently on the market for migraine treatment. And comparing that topiramate to placebo, they only saw a reduction in headache frequency of about a day per month, so comparing a traditional treatment that’s out there versus a probiotic, 2 1/2 versus a day. It’s again another option.
Molly: Do you think that we’re going to see continual efforts to study probiotic and its impact on migraine, or do you think more research needs to be done?
Samantha: So yeah, I definitely think both. So more research definitely needs to be done to validate these results as well as replicate them in populations closer to home. If we’re thinking of U.S. or even European populations — Iran populations definitely need the same sort of treatment, but their diet, their environment is different. So there is actually a study being put together at the moment looking at the same — sort of repeating this trial but with a U.S. population, multi-centered, actually, here.
Molly: So people with migraine want any type of relief. If someone out there with migraine sees this study or listens or watches this interview and they’re interested in taking a probiotic supplement or improving their gut health, what do you suggest they do?
Samantha: Yeah, so first and foremost, I think talk to your healthcare provider. There have been no adverse effects listed with this product or any kind of probiotic out there saying that those who are immunocompromised are cautioned to take a probiotic supplement. But for the general population, I think it’s important to talk to your healthcare provider, mainly because they know your treatment plan, they know your medical history, and they should be informed in that process.
Other than that, it’s really what fits into your lifestyle. So you can easily reach out to any company. Any reputable company will have someone that will get back to you to answer your questions. But there are refrigerated, not refrigerated, liquid, pills. So yes, one can be better than the other. One can work for you more than the other. It is a little bit about trial and error, but you should also scientifically, critically yourself assess what’s out there, if they have research available for you to look at, if there is a good review or following behind them. I mean, I think those are all good signs to follow.
As well as just having an open conversation with that company or a lot of companies do train or offer training for local pharmacies or even the bigger stores. So you can have a conversation with those people working in those departments to kind of assess the pros and cons of each product or thing you’re looking for.
Molly: That kind of leads into my next couple questions. Is there anyone who really should avoid taking a probiotic supplement?
Samantha: Yeah, so as I mentioned, those who are immunocompromised, we caution taking one there. There hasn’t been much research — as well as having an open conversation with your healthcare provider — but women who are pregnant or breastfeeding should definitely have that conversation. And in terms of this Migréa particularly, children under 4 are cautioned, and we’re very hopeful that they’re not suffering from migraines under the age of 4. But other than that, as I mentioned, there haven’t been any adverse effects that have been suggested from taking probiotics.
And as well as the magnesium and vitamin B6 that is in this, specifically, magnesium citrate is often suggested, magnesium itself, for those taking migraine. And the amount in this particular product is at a dosage low enough that if you are already taking magnesium, it’s not going to put you over the recommended allowance. And same with vitamin D (sic). The amount is really there to help support the immune system and any sort of fatigue and depression symptoms you might be having and won’t put you over that RDA allowance.
Molly: And Sam, you kind of spoke a little bit about this, that it’s really good to check in with your doctor and do a little bit of research. But as more and more people are interested in probiotics, we’re starting to see the marketplace flooded with products like this, and it’s kind of hard to decipher what’s good, what’s not good, what is a sham product. So what should people do if they’re interested but they’re a little overwhelmed with the types of products that are out there and what they’re interested in and what they should be taking?
Samantha: Yeah, good question. Again, I think talking to your healthcare provider is your first stop. They should hopefully have a bit of an idea of what’s going on once you’re on. In terms of each product or brand or strain, it’s a very overwhelming, like you say, market. I think that’s again where coming to talk to the company is important, seeing the amount of research versus marketing material that they have out there, even things as simple as having a piece of literature stating that what is in their product is in their product, right? Testing to make sure the ingredients are actually there.
And I think it’s also useful and important to use your support groups around you. So while they might not have the most scientific knowledge, a lot of times, they tend to exchange ideas or what works, what doesn’t work, what’s the best way to do something. So I think that’s a good initial reference point to then jump off and be able to do your own research from.
Molly: Yeah, it’s interesting because so many people live and breathe by probiotic supplements, but then there’s these products out there that you can find sometimes at the gas station. And so sometimes it can be confusing for consumers to really know what’s real, what’s not real. So it’s interesting to say not only talk to your doctor, but to talk to others and see what’s out there, and what might work for you might not work for others. So thank you for some of that advice.
It’s always interesting to be able to pick the brains of people who are in the field and know about the field, because you not only have education in nutrition, but you have education in the science as well.
Molly: So what other ways can people improve their gut health besides taking a probiotic supplement?
Samantha: Yeah, sure. So there are lots of foods that you can take. You can find them in the store. You can make them at home. So things like yogurts are a great place to start, whether those are non-dairy or dairy-full. They often have live bacteria inside as part of that process. I would caution getting those that are overly sugary, though, as that tends to affect the viability of the bacteria inside. Things like sauerkraut, kimchi, even kombucha are great places to initially start to dabble in that realm.
But if you don’t want to actually think about or put live bacteria into your body, you can take prebiotic foods, so prebiotics versus probiotics. Prebiotics are those things that actually feed the bacteria that live inside of us. You’re helping to support the ecosystem you already have. And those are things like leeks, things that are very full of fiber that we ourselves aren’t actually able to digest but the bacteria inside of us can, and then you help to support their growth.
Molly: Any parting thoughts for those living with migraine?
Samantha: I guess I’d have to just say the struggle is one that has to be fought daily, and for those of you — you are some of the strongest people out there because migraines are invisible — right? — and you can only feel the pain yourself. But there are new treatments and groups and things that are out there to help support you, and I think that the best thing you can do is to speak up and say what you want or what you need. Help to direct the flow of that research, the flow of those treatments, because you are the only one who are going to be able to know what actually works and what actually is needed.
Molly: That’s great. Thank you, Sam.
And that wraps up Spotlight on Migraine. Thank you so much for joining us today. I’d like to say thank you to Samantha Stone. She is with ADM Protexin. Thank you again for joining us. I’m Molly O’Brien.
Samantha: Thank you for having me.
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This podcast is sponsored in part by Amgen/Novartis.
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