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- [00:00]
Dr. Chapa
Foreign. As you all know, it's our typical modus operandi, our typical MO that we try to get you stuff that's fresh off print, right off the press and let you know what's going on in the literature. Well, we're going to do that today because something came out yesterday, and as office point of reference, we're doing this on March 6, 2025. Something came out yesterday, March 5th 5th, 2025, in the New England Journal of Medicine. The New England Journal of Medicine. This is actually from an Australian team talking about bv. Now, we've talked about bacterial vaginosis a lot on vaginitis and vaginosis and their treatment, especially when they're recurrent on this channel. In the past, we've touched on that, we've talked about vaginal probiotics, we've talked about a lot of different things. But. But here's what's interesting. This is a never ending story. So I'm always in for additional information, especially for patients who have recurrence here, for a way to get ahead of this. Okay, so we're going to talk about our chief article here, but you know, we're not. Not just going to talk about this one thing. We're going to relate it to a lot of different things, including what the CDC says, which is now a little bit outdated, and then bring this back to the same group of authors who first published a similar publication three years ago, okay? Because they first did this October of 2021 in a whole separate journal, okay? They did this out of the journal M Bio, which is a microbiology journal, M Bio. The same group of authors already did this, guys, and the CDC that made that study made its way to the CDC information page on bv. I'm gonna tell you that in a minute, okay? So once again, nothing new under the sun. However, that study in 2021 was, was really kind of a pilot test. Actually the title is a prospective open label pilot study of concurrent male Partner treatment for bv. Did y'all get that? So that was a pilot of maybe we should treat the male to bring down the risk of the patient of the woman getting recurrent bv. Okay? Now in this study, things did work, although there were some issues there that we'll discuss. Well, the same authors are back now with this new publication now from March 5, 2025 now in the New England Journal of Medic, which is the exact same concept, exact same treatment, but on a little bit larger scale. Okay? Which is good because up to a third of women are going to have bv, and recurrence can be as high as. Based on who you read, 50, up to 70%. And it depends on what time frame you look at. That's within 12 weeks. Some people say within four months, which is 16 weeks. So it depends. But all to say, BV is very, very common. Okay. Up to a third of reproductive age. Women, based on the data, have it at some point. Although not everybody is completely symptomatic, some are more than others. And of course, we know that there's a certain percentage that have asymptomatic infection. You come in to do a pap smear and you're like, oh, by the way, did you know you have milky white discharge, maybe with a little bit of an odor? And they'll go, I don't know, maybe. It doesn't really bother me. So there are some asymptomatic states. Okay? But we're gonna get into this open label, randomizes, controlled a study that looked at treating the male partner as a way to reduce recurrence in the woman, and it worked. Okay, so let me just set that. Let me just say right now, this did have very. It had such promising results, guys, that they stopped the study early and said, hey, it's not fair to the control arm to not get this. So we're just gonna call it a wash. We're gonna call it a day and say, yes, Treatment of the male by this specific pattern, by this specific medication. I'll tell you in a minute. Should be done. Okay, so you're like, great. All right, well, thanks, Chapa. That's good. I guess I'm done here. No, no, no, because we gotta dive into it a little bit more because there are some interesting points to the study that kind of make you kind of question a little bit some of the data. And I mean that in a bad way. I'm just. I'm gonna tell you what their primary end result was when we dissect this. So let me just be very clear here. I think this is great. Anything that potentially give patients, especially with recurrent BV, some relief, I'm all in. I'm 104. Remember our motto here. Can it help? Yes, it seems that it can help. And can it hurt? No, it does not seem to hurt. So I'm all for. Especially in patients who have recurrence. I don't know so much on the first episode. You know, she's otherwise young. She's not really. It's not like it's there, but it's not really that big of a deal. I don't know if I'm necessarily offer this treatment to everybody, but especially for those who have recurrence of bv, I think this is something to pay attention to. Okay, now. And yes, the majority and this. This population that was studied is not just for recurrent BV patients. These are patients who presented with bv, and it just happened that in this population, the majority of them already had a previous diagnosis of BV in the past in it was like over 85% had some kind of BV history. So the majority did have BV previously. It was not their first episode. Okay, so again, what you do with this? Do you do this on the first patient who gets a first diagnosis of bv? Say, oh, you gotta treat your partner, or say, hey, it happens. It's not a big deal. Historically, we have not treated the male partner, although there is some data that potentially could be helpful, especially when it's a recurrent issue. We're going to get into that in this episode. All right, There is some big value here. This is one of the biggest multicenter randomized studies that have looked at combination therapy for treating the male. Combination therapy. Y'all get this, y'all. I'm still in the intro. I haven't. I'm not supposed to tell you any of this yet, but I can't help it because it's actually good stuff. The combination is a combination of oral and topical antimicrobial therapy for males. Now, people have been looking to put stuff on. On the little head of the penis and the prep use for decades. All right. I mean, I remember a study, I think it was like 2011 that was done. Or was it 2013? It was actually 2013 in sexually transmitted diseases. All right, 2013 in STD. Yes. There's a journal called Sexually Transmitted Diseases where they actually put this combination alcohol gel on the tip of the penis and to see if that could reduce the rate of bv. Okay. And it didn't work at all. Like, not only did it not work, it actually increased the rate of infection. All right, so people have been looking at treating the male partner for some time, and it's been very controversial in the results. I wasn't going to cover that. That publication originally out in 2013, but I think I may just to give some point of reference, because I just looked it up right now and I found it originally published ahead of print in 2011. Boy, that's a big lag time there. And then in 2013, officially out in print in January 18, 2013. And the title of that separate early study was topical penile microbicide used by men to prevent recurrent bacterial vaginosis in sex partners. And this was an rct. We may just touch on that when we come back out of the intro. The point is people have putting, have been putting stuff on, on the men, on the male partners for some time now, trying to decrease bv. Okay. And, and that study, as I've already alluded, to make things worse. All right, so this is a point of contrast that it depends on what you treat with to prevent recurrence, which will guide your success here. Okay, so our main article of focus as we get out of the intro because this is way too long already. Our main focus is male partner treatment to prevent recurrence of bacterial vaginosis, published out of an Australian research team from March 5, 2025 in the New England Journal of Medicine. We're going to talk about their first publication briefly, which came out in 2021. We're going to talk about the CDC's current stance and then we're going to wrap this up and give you some clinical applications as we get to the end of the episode. Like what about condoms, y'all? Condoms for prevention of BV is not super, super hard and fast data, but it's pretty darn convincing. CDC says so. Infectious Disease Society of America says, hey, it can't hurt. And it can only help because condoms do have some kind of benefit in prevention of recurrent bv. And that goes all the way back to a systematic Review back in 2008. 2008-008-008. So we've known that for a while. All right, I think I've set it up enough. Let's get out of the intro and we'll be right back. This is clinical Pearls. We're so done with New Year, new you. This year it's more you on Bumble. More of you shamelessly sending playlists, especially that one filled with show tunes. More of you finding Geminis because you know you always like them. More of you dating with intention because you know what you want and you know what? We love that for you. Someone else will too. Be more you this year and find them on Bumble.
- [10:23]
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- [10:53]
Dr. Chapa
I do think this is an interesting idea. Again, I'm all for it. For those who have recurrent bv, I think I'm going to offer this. It did make its way into the CDC's guidance on this back when the authors did their 2021 publication, which is what we're about to cover out of M. Bio. That's a little M. And then Bio, that is the journal of the American Society of Microbiology. I know you subscribe to that. Don't lie. I mean, how boring is that? Oh, my goodness. But anyway, whatever. The American Society of Microbiology, the ASM journal. All right, mBio. So the same authors did this about three years ago. And this data from 2021 actually made its way. I'm going to read it to you directly from the CDC website regarding partner therapy. Okay, now before I do this, before I get into this 2021 publication and then go into our new study, by the way, if you hear noises in the background, it's because literally I am in a call room and there's people walking up and down. But I wanted to get this done because I'm sure you don't want to do it tonight. I got other things to do. But I do want to say something very quickly about our immediate past episode, which was about in utero treatment for spinal muscular atrophy. SMA. Fascinating. What was done there out of St. Jude. But I mentioned something in the intro. I did a little correction. If you don't know what I'm talking about, you got to go into the episode right before this one that's called Danny versus Dave Thomas. And so anyway, I told my, my show producer, Michael, I said, hey, Mike, why did you tell me? I said, dave Thomas. I went down that whole rant on Dave Thomas and it was Danny Thomas who founded St. Jude's and he's like, man, I don't know anything about. I don't want. I don't know anything about that. I trust you to get it right. I don't know anything about that. You say it, it sounds okay. And I put it in. To which I said, let me give you a little Reagan esque quote here. Whatever I say, your job is to trust but verify may give you difficulty. The maxim is dover yai no provi. Trust but verify. To which he said, I don't get paid enough to do that. So anyway, so as I mentioned in the Correction. Trust me. Trust me, guys. Everything that I tell you is legit. That's why we have a whole reference page for our podcast, so you can look it up. But, yeah, I did kind of mess that up a little bit because I said Dave Thomas, and it was the famous actor Danny Thomas, who's also a fantastic singer. Anyway, I just threw that out there. Trust but verify. Okay, none of that was relevant. What am I doing now? Hold on. I lost my place. Oh, here it is. So let's go to 2021. So these same authors out of Australia, very quickly, I'm just gonna. And then I'm gonna get into this new publication so it can be done before this lady delivers. In 2021, these same authors published out of mBio, a pilot study called a prospective open label pilot study of concurrent male partner treatment for BV, exact same protocol that was now out 24 hours ago, March 5, 2025. Okay, by the way, if you don't think this is relevant, I just got a bing, a little ping, little pop up from my email from one of our, you know, medical sites that we subscribe to that said, oh, look, treating male partners for BV may reduce recurrence. I'm like, I'm all over that. I'm already over that, honey. I'm doing this right now. So this is definitely making its way as I'm recording this. This came out on MedPage Today. Now, and even though you're like, well, I can just read that article. No, no, because you don't get this all the background story like I do here. Remember, at Clinical Pearls, we try to provide the big picture, not just the one puzzle piece, which is like MedPage Today just tells you, hey, here's what the article said. That's it. We give you this background commentary and put it in perspective with what already exists in the literature. Okay? So having said that, let's go back to that 2021 publication out of mBio. And then here is what the CDC says about it, because that study, that pilot study made its way into the CDC information. So let me read it directly from the CDC guidance from CDC.gov STD treatment guidelines,/BV, short of it is STD guidance under BV, because even though BV is not a STD, it does have sexual transmission traits. All right? As you. As we already know. So here's what it says by the cdc, under management of sex partners as it relates to these authors from Australia. So here it is. Quote, data from earlier clinical trials indicates that a woman's response to treatment and the likelihood of relapse or recurrence are not affected by treatment of her sexual partners, end quote. So right there, the first sentence, under management of sex partners are like, it doesn't look great. We don't have a lot of data. It's not that good. But whatever, they keep on, they keep going. So listen to this quote. Therefore, routine treatment of sex partners is not recommended, end quote. Now, I get that. Remember, the publication that we're, that we're reviewing here and highlighting is just 24 hours old. So it hasn't made its way into the cdc. So what I would like to see is, however, even though it's not uniform and there's a lot of issues here, it might could help. Okay, so it could possibly help. It seems to not hurt. So potentially it could be beneficial. Okay, so let me continue now, under the CDC guidance, under management of sex partners, as it relates to these authors from 2021, because the next sentence is exactly that 2021 publication. So here's what they say. Quote, a pilot study reported that male partner treatment, metronidazole, 400 milligrams orally two times a day. So that's the first catch. Did y'all get that? Flagyl, 400 milligrams two times per day. What's the CDC dose, guys, for us in the US 500. So maybe. So they're a little under therapy. Okay, so they used metronidazole, 400 milligrams orally two times a day in conjunction with 2% clindamycin cream, which was applied topically to the penile skin two times a day for seven days. These were partners of women with recurrent BV, had an immediate and a sustained effect on the composition of the vaginal microbiota with an overall decrease in bacterial density at day 28, end quote. Let's stop there. It's like, oh, wait a minute. That's good, right? Yeah, that, that's real good. However, they keep going. Quote, a phase 3 multi center randomized double blinded trial evaluating the effect effective effectiveness of a seven day oral metronidazole regimen versus placebo for treatment of male sex partners of patients with recurrent BV did not find that male partner treatment reduced BV recurrence in female partners, end quote. So they present two different sides, right? One is this Australian study from 2021 that says if they take oral medication and maybe a topical the combination therapy, maybe it could have a result here at least by day 28. But at the same time, another Study that was just oral therapy did not seem to help. So remember, as of the CDC's guidance, which may change, but as of right now, as of May 6, 2025, it says, quote, routine treatment of sex partners is not recommended, end quote. I just want to tell you what's out there so that you don't say. I'm saying something outside of the cdc, because I've given you the CDC guidance. I think this is helpful, what these new authors found, even though there is some limitations in the interpretation of the data. Okay, so that's that. So now that we've left that, and we'll get into the condom issue in just a minute, let's get into this new publication from New England Journal that came out in the last 24 hours on March 5, 2025, because it's the exact same study protocol that was used in 2021. So patients presented with a complaint of. Of bacterial vaginosis. The males had that combination therapy of oral metronidazole, 400 milligram tablets, and 2% clinda applied to the penile skin. Now, they actually did stratify for two big factors which are linked to BV occurrence and recurrence. What are they, guys? Okay, what are the two big factors IUD use? Right. We would know that specifically copper T. And then the second is whether the male is circumcised or uncircumcised, because, based on some data, uncircumcised males may potentially have an increased risk of recurrence with a female partner, whereas others say it doesn't matter if it's circumcised or not. But some studies do show that uncircumcised male tends to, especially if they don't clean under the foreskin, may potentially harbor some of the bacteria that's going back and forth. All right, so they did control for those two things, IUD use and circumcision in the men. And let me just tell you right now, neither of those two things seemed to matter. So it didn't matter whether they had IUD in place or not or whether the partners were circumcised or not. Again, which is a little different from previous studies, because most of the data has favored treatment when the male is uncircumcised. Okay? So I'm just telling you again, very complicated here. All right? So anyway, this was an open label. This was randomized. This was a controlled trial for women with BV who had to be in a monogamous relationship and had to have a male Partner. All right, so the patient had treatment and then the intervention group had the patient get their treatment along with this male combination therapy that we've already discussed. All right, so that was intervention arm, and then the control arm was just the standard treatment of the female partner. The primary outcome was recurrence of BV within 12 weeks. Okay, so this is just, and I'm not saying just like it's short. I mean, 12 weeks is good three months, but you know, there's a lot of time after that where it still may happen. So that's one of the limitations they looked for for 12 weeks. Right? 12 weeks, three months, which is good because in the original study, remember, that was pretty much like four weeks, 28 days. Okay, so in this publication I did find something that was interesting, which was that the treatment for the males was metronidazole, 400 milligrams, whereas here in the US remember that we stick to the standard is 500 milligrams twice a day. So it is a little different based on what we have here. And so just something to keep in in mind that that wasn't necessarily what we would do here in the US because we would do 500. Fine. Why don't we take a quick break, let that settle in and we come back. I'm going to read you the the primary end result here, the secondary end result, give you the overall results, and then we're going to bring this home. Talking briefly about the use of condoms for recurrent BV prevention. We'll be right back. Hey, we're glad you're part of our podcast community. You're listening to Clinical Pearls.
- [22:17]
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- [22:47]
Dr. Chapa
On March 21, the magical tale Snow White. Snow White, Snow White that started it all. I believe you're looking for me. Arrives in theaters. Magic mirror on the wall Exp Experience the Disney classic who's the fairest one of all? Like never before. We haven't even been in regards yet. Disney Snow White Only in theaters March 21. Rated PG parental guidance suggested, yes, we're going to get into the results of this 2025, March 5th publication. But remember I said that people have been looking at putting things, medications or ointments or whatever on the male penis to try to reduce female BV. And I mentioned the 2013 publication. Well, let me just tell you what they did in this study as a little caveat. See, I'm telling you, what I tell you is legit. People have been looking to do something to treat males for a long time. They're like, I'll just cover it up. Just put, just put a condom on it and you'll be fine. And that's true. Condoms do have a decreased rate of recurrence. We'll get into that in just a bit. But According to this 2013 study, just as a little caveat, as a little side detour here out of sexually transmitted diseases, this clinical trial actually found that if the male puts on daily this gel of 62% ethyl alcohol. You heard right, guys. 62% ethyl alcohol to the tip of the penis and the glands and the top part of the shaft, it actually increased or increase the rate of both persistent and recurrent BV in their partners. In other words, it actually backfired. The diagnosis of BV was significantly more frequent in the intervention arm, even after adjusting for other factors. All right, so first of all, trying to get a buy in to say, hey, can you rub this 62% ethyl alcohol gel on your penis daily? Let's see how that goes. Hey, I don't know, maybe that doesn't hurt. Maybe it does, I don't know, but doesn't sound like fun to me as a male can just say it right now, 62 ethyl alcohol gel on the PP, not so much. And thankfully it didn't work because that'd be a tough sell. But in this case, it did not work. So anyway, I thought, I thought that was interesting as I told you, that people have been looking to find a treatment for males that would work. And that leads us now into this March 5, 2025 and these specific results. All right, everyone, we're back. And I told you that I think this is super helpful information. However, there are some things in this study that you have to pull out, not read too fast to go. Well, that was interesting. So the 400 milligrams of metronidazole taken bid is one thing, because here in the US we do 500, but that's a minor issue. But let me read you this under the subject heading Participants in the study, in other words, those who had either the intervention arm or the control. Quote, first premenopausal women were screened. They were eligible if they had symptoms of BV Good. And met the diagnostic criteria for the condition presence of at least 3 of 4AMSL criteria and a Nugent score of 4 to 10. End quote. So let's stop there for a minute. Okay, fine. Now that's so Amsel's criteria using clinical markers and the Nugent score, which is actually, you know, staining it to, to actually get a more standardized view, I think that's fantastic. However, I think most people, at least in the US while there's still wet prep, is still a thing. I'm not saying anything against that. And using clinical criteria, there's things like the affirmed vaginitis test, which now uses point of care like nucleic acid amplification tests because you have much more reproducibility and less intra observer variability than using something like Amsells or a Nugent score. Nothing wrong with that at all. Right? But remember that. So that's my first thing is that they did not use kind of a DNA test that would be nice to do the AM cells and a new gen and maybe even get your triple verification that we even confirmed with the point of care. So that wasn't done, but nonetheless, that's fine. So now let's keep reading this for a minute. Okay? So quote, the patients also needed to have a regular male partner for at least eight weeks before enrollment and were receiving first line antimicrobial treatment, which was metronidazole, 400 milligram tablets twice daily for seven days, or if that was contraindicated, then they had intravaginal 2% clinda once a night for seven nights or 0.75% metronidazole gel or metrogel. Fine, no problem with that. But again, notice the metronazole at 400. Again, we use the 500. Just little differences here. Okay, so that's that. Those were the ones who participated. Now look at the outcomes because this reads a little interesting. So let me just read you the outcome. The, the primary efficiency outcome was recurrence of bv. You're like, great, but listen to this. What defined that? Defined by both the presence of at least three Ansel's criteria and the Nugent score of 4 to 10 within 12 weeks, end quote. Let's just. Did y'all get that? Did you notice something in there? So you guys, you got to look at this critically. The jogging. Let me read that again. The primary efficacy outcome was recurrence of BV defined by the presence of at least three AMTOs criteria and a Nugent score of 4 to 10 within 12 weeks. Anybody see anything in there? The primary outcome I would have thought would have been symptomatic patients who complained of bv, not just finding it on the lab test, because are we treating the lab? Are we treating the patient? So I just found that interesting. All right, so listen to this. And I get it, please don't send me a message. Well, this is more objective, I get that. But the most objective is doing the net. So bleh, that wasn't done. But if you notice, look at the participants who was recruited, patients who had symptoms of BV and then met the diagnostic criteria of Amsels and Nugents. Okay, they had symptoms. But if you look at, under the primary results, it's those who had BV based on the lab criteria. In other words, if I find that you have an Amsel's criteria or your NuGent is between 4 and 10, but you're totally okay with it, you're like, I don't feel anything. What am I actually treating? Does that make sense? Again, I'm not knocking this. I just found that interesting. That's all. You do with what you will with that. Now the other issue here, which I get, and it's fine, is that it wasn't really blinded because those that were in the intervention arm, the partner had pills, had Flagyl 400 bid and also the topical clindamycin cream to the glands and also the top part of the shaft of the penis. Okay, but there was no placebo cream. And I understand why their statement was if no matter what kind of placebo gel we use, it could have been Aquaphor, it could have been a water based gel, whatever, and not told them just say use this. The problem is that that may have some kind of negative effect on the microbiota one way or the other. And so we didn't want to cloud that. So there was no placebo gel for the control. Does that make sense? So again, that's not, that's fine. But I'm saying that there wasn't necessarily blinded in that way for the control room, for the control group. Okay, so the intervention is patient gets treated and partner gets treated with oral medication and the topical. The control is just the partner. Just the patient rather gets treatment. So very shortly, let me just give you the results here and then we'll call it a day because then we've got a little thing to discuss on, on the issue of condom use. Okay. All right. Under quick results, very quickly, to just knock this out. Yes, they stratified for things like IUD use, as we talked about, and even the issue on circumcision, and it did not seem to matter. So what they found was, quote, in this multi center randomized trial, the addition of oral and topical antimicrobial therapy for male partners at the time that their female partners were treated for bacterial vaginosis resulted in significantly lower recurrence rate over a period of 12 weeks than the recommended practice of treating women alone. End quote. Now, remember, most of these patients, 87% actually, 87% had BV. Okay. And most had actually an uncircumcised male partner, like at 80%. So just something, something to. To note. All right? Most had an uncircumcised male partner at 80%, and 87% had a history of BV in the past. So just for what it's worth to put that out there, now, the percentage rates of those who had BV in the intervention means treating the partners and those who did not. It was pretty drastic. I mean, it was, it was a big change. Okay, so those who were in the control had a recurrence rate of over like 65%. And those who had a treatment of the partner, their chance of having BV was 35%. So let me just say that right off the bat here, it's not like it was zero or it was like 10%. Those that were in the intervention group whose partners were treated still had a recurrence of BV of like, you know, over 30%, like 1 in 3. So there's the difference between a treatment effect which is good. I mean, this was, this was better. I mean, 35% in the partner treated group is good, but it's not like it's a zero. Okay. And those that were in the control where the patient was treated by themselves, it was, it was 63% recurrence. So 63% just by treating the patient, and then 35%. So almost basically cut in half if the partner was treated as well. Okay, so it's helpful. I mean, this is good to know. I mean, yes, it dramatically dropped, but you got to tell the patient that if you give the partner, the therapy doesn't move the risk down to zero or doesn't even move it to one in four, which would be 20%. Or one in five, which is 25% is one in three. So it's still pretty darn high, but much better. Than the 60% ish if the partner did not have treatment. Another. The third point to make here as we get ready to wrap this up is that even though this was a multi site and it was temporarily interrupted by the whole coronavirus deal, the numbers weren't very, very high. All right. Because it was 81 couples were assigned to the partner treatment group and then 83 couples to the control group. So we're talking about just over 160 as an N, which is good. I mean that, that's, that's totally acceptable. When the original trial was supposed to be much higher than that. But they stopped it early because of the net benefit that was seen here at a recurrence rate of 35% as opposed to 63% by including partner therapy. Okay, so what's my take on this? Why not? I don't know if I'm going to do it with every patient, but for those who definitely have recurrence, I think it is something to consider. Consider. Even though there was no difference here based on circumcision or IUD use, previous studies have said that there is. So that's something to consider. And then the last thing is, remember that condoms, condoms do actually have a role here. They can help. As I mentioned, that goes all the way back to a systematic review back in 2008 that showed that, look, if the male sex partner uses a condom that it may actually help reduce the recurrence rate of bacterial vaginosis. That was published in Clinical Infectious Diseases in December of 2008. So we've known that guys for almost 20 years. The title of that systematic review was Sexual risk factors and bacterial vaginosis A systematic review and meta analysis. So condoms are something that is super easy to do with the other additional kind of. Because nothing is free. Right. The other additional kind of pain in the ass thing is that persistent condom use, especially if they have traditional spermicide, can kind of irritate the vagina because of the spermicide agent, which is a detergent. Nothing is free. All right, all right. So very quickly we've just summarized this new publication which is out of New England Journal of Medicine that potentially, potentially treatment of the male with oral and topical to precinctly nemycin to the glands of the penis and the shaft of the penis may potentially help reduce at least cut in half the rate of recurrent BV in the patient up to 12 weeks from index therapy. Not for life. Guys, you got to put this in perspective. This is not like you. You will never get BV again again. Again. Again, no, no, this is just for 12 weeks. 12 weeks, which was the end point of the study. With the little caveats that we discussed, it's not the same dose that we would use here. The primary outcome was based on a lab criteria, not necessarily patient symptoms. Found that interesting. But with an end of basically 80 in each camp, it is not something to ignore, which is why it's making its way around the OBGYN and the family medicine press. All right, our job here is to let you know what is hot off the press. We will likely get this packaged and put together and maybe released tomorrow, March 7th, so it doesn't linger. But I've got to finish call today, and I think I've got something coming tonight I'm supposed to do. But anyway, as always, Podcast family, we're super thankful for you, y'all. That little mess. I got four messages on the Danny Thomas and Dave Thomas thing and just made me smile because number one, you can always reach out. Number two, know that somebody, either Michael or myself, if it's worth responding to, I'll respond to. And this is how medicine should be. I. We. It's almost at least daily where there's one or two questions that come in from our podcast family. I'm talking about general obgyn, generalist, gynecology, mfm. But great question. This is how we build each other up and sometimes we share ideas. Hey, what do you think about xyz? Well, I hadn't thought about this. What about DEF or whatever? And that's how medicine, I think, should work, to build each other up and encourage one another to better take care of our patients. All right, everybody. Podcast family, we're thankful for you. We're glad you're part of our podcast community now that we've said all that. Need to get back to L and D and let's take it home. Podcast family, we really are thankful for you. We hope you enjoyed this episode. We'll see you next time on Clinical Pearls.