Double T Healthwatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.
This week's topics include blood levels of sunscreen ingredients, a new drug for heavy menstrual bleeding in women with fibroids, trying to stave off sepsis, and fish oil and sperm quality.
Program notes:
1:17 Vitamin C, thiamine, and hydrocortisone in sepsis
2:17 Mortality and other endpoints
3:16 Prompt use of antibiotics does help
3:36 Fish oil and sperm quality
4:36 In otherwise healthy men
5:38 Might improve sperm quality decline
6:00 Sunscreen ingredients in plasma and skin
7:00 All six of tested ingredients were in plasma surpassing FDA threshold
8:00 Doesn't indicate harm yet
8:40 Heavy menstrual bleeding and uterine fibroid treatment
9:40 Been used in endometriosis
10:40 Hot flashes associated
11:24 End
Transcript:
Elizabeth Tracey: Learning about how much sunscreen ingredients are absorbed.
Rick Lange, MD: An oral therapy for women with heavy menstrual bleeding from fibroids.
Elizabeth: A simple intervention for trying to prevent sepsis doesn't look like it works.
Rick: And can fish oil supplements improve testicular function?
Elizabeth: That's what we're talking about this week on TT Healthwatch. That's our new name -- formerly known as PodMed TT -- your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I'm Elizabeth Tracey, a Baltimore-based medical journalist.
Rick: And I'm Rick Lange, President of the Texas Tech University Health Sciences Center in El Paso, where I'm Dean of the Paul L. Foster School of Medicine. Elizabeth, I'm excited about the name change. You know, we're going into our 15th year of recording medical podcasts together -- again, as the first medical podcasters in the world -- and this reflects the support and the direction that we're headed. I'm excited about this new name change and we're going to be announcing it over the next several times, but our listeners will get the same quality.
Elizabeth: Thank you so much. Let's turn to the Journal of the American Medical Association. This is a story that I've been watching for quite a long time. There are a very large number of peer-reviewed studies that are going on all around the nation -- in fact, all around the world -- taking a look at vitamin C, hydrocortisone, and thiamine supplementation for people who are developing sepsis in the ICU. This really intense investigation has been based on a single study that was undertaken and reported that showed that this particular combination, when administered to folks who were at risk for developing sepsis or looked like they were developing sepsis in the ICU, dramatically reduced their mortality.
So this is one study that was conducted in Australia, New Zealand, and Brazil. They got 200+ patients who fulfilled Sepsis 3 definition of septic shock. They were randomized to intervention consisting of intravenous vitamin C, hydrocortisone and thiamine, and then the control group, which is just intravenous hydrocortisone alone. And they said, "Are we going to have shock resolution for up to 10 days following this initiation?" There were a couple outcomes they were looking at. One of them was that time interval without needing pressors to maintain their blood pressure, and then the other ones were mortality and other secondary endpoints. And the upshot of the whole thing, very disappointingly for me -- because I was really quite interested in this initial study -- was that there was really no difference. There was no benefit in this administration.
Rick: Elizabeth, as you alluded to, the thing that got this off the ground was an observational study of a small number of patients and generally a lot of enthusiasm. In fact, there are people around the world using this type of therapy, but not only this study. ****But there have also been eight randomized controlled trials and other observational trials that have shown no significant effect of vitamin C on mortality. So I think what this tells us is, despite the initial enthusiasm and optimism, we need to move on. Vitamin C alone or in combination with thiamine and hydrocortisone does not improve the overall outcome, so we need to reinvest our time in things that might improve outcome and not give false hope to patients, either.
Elizabeth: Agreed, and the editorialist notes, of course, that one thing that is known to reduce mortality from sepsis is early spotting and initiation of antibiotic therapy.
Rick: Right. In fact, every hour that we wait tends to increase mortality about 10%. So as you mentioned, we know early initiation of antibiotic therapy is effective and should obviously be a major focus of every medical center.
Elizabeth: Well, if you're okay with this, I would like to turn to JAMA Network Open, one of yours. This was the very provocative study taking a look at fish oil supplementation and human testicular function. Certainly, we've been taking a look at the benefits reported or not of fish oil supplementation for quite a while. This is the first time I've heard about it in this particular role.
Rick: And the reason why this is an issue, if you look worldwide, is semen quality has really declined worldwide. There's some geographic variation. For example, this decline is more prevalent in developed and industrialized countries. And we know that some things are associated with that -- things like pollution, smoking, alcohol consumption, decrease of physical activity, and stress -- but there seem to be some dietary associations as well. Foods that were high in fish, shellfish, seafood seemed to improve sperm quality in men that were infertile.
So what these Danish investigators attempted to do was to see whether there was any correlation or association between fish oil supplements and sperm quality or testicular function in otherwise healthy men, so these were not men that were infertile. In fact, these were men that were applying to the Danish army and they weren't accepted for whatever reason. They enrolled them in a study and said, "Listen, would you be willing to assess testicular function and sperm count?" and then they did a dietary history. Some of them took dietary supplements like vitamin C and vitamin A. And a certain number -- about 6% -- actually took fish oil supplements, some for more than 60 days, some for less than 60 days.
When they compared those men that were on fish oil supplements to those that were not, those that were taking the supplements had larger testicular size, greater sperm volume, a greater sperm count, and more favorable reproduction hormones as well. Not causality, but an association in otherwise healthy men between fish oil supplementation and better testicular function and sperm quality.
Elizabeth: And I think that you pointed out exactly the most important aspect of this, which is that we've been reporting for a while about this decline in sperm quality. This could be a very simple intervention that might improve it.
Rick: Right, and somewhere about 1 in 20 couples have fertility issues. About half the time, it rests with men. It would be nice to do a randomized controlled trial where you take otherwise healthy men and then provide them fish oil supplementation. I wouldn't be surprised if that's in the future.
Elizabeth: Okay, back to the Journal of the American Medical Association. Again, something that's been emerging for a little while. We've mentioned it before. What happens with sunscreen ingredients in terms of their plasma concentrations for a lot of different kinds of sunscreen products? This study is a small one. It was conducted in a school of pharmacy. They had 48 healthy participants and they randomized them to 1 of 4 sunscreen products -- either a lotion, an aerosol spray, a non-aerosol spray, or a pump spray. There were 12 folks in each group. Then they applied this stuff to 75% of their body surface area and they collected all kinds of things from them, and then they analyzed a lot of these different datapoints through Day 21 following Day 1.
They did something that I thought sounded a little uncomfortable. In addition to the plasma concentrations, they also took a piece of tape and put it on their lower back and pulled it off, and actually gathered this shedding skin sample so that they could look at the concentrations of all these different things. They found out that, in fact, all six of the tested active ingredients administered in four different sunscreen formulations were systemically absorbed and had plasma concentrations that surpassed the FDA threshold for potentially waiving some additional safety studies.
So my point about this whole thing is that these are widely used. People use them on a daily basis. They're in cosmetics as well as in sunscreen products, and we really don't know anything about their safety.
Rick: Elizabeth, you're right. The way they applied it, the first day they applied it over 75% of their body one time. Then for the next 3 days, they applied it four times a day. Now, first of all, most of us don't use that much sunscreen, but nevertheless, there was systemic absorption. The skin ends up being a reservoir. Even in these individuals that weren't applying it later, it still continued to be absorbed.
Now, our listeners should be aware of a couple things. One is this just shows systemic absorption. It doesn't indicate there's any harm yet. There are two different types of sunscreen. There are these chemical sunscreens, but then there are mineral screens. These are things like zinc oxide and titanium dioxide that don't get absorbed, so there's an alternative. We need to take it to the next step and say, "Is this harmful or not?" I'm sure we'll be hearing more about this in the future.
Elizabeth: No question. The authors do note, of course, this does not mean that people should cease using these products right now because it is well established that they do reduce the incidence of skin cancers.
Rick: And that's more common in people that are light-skinned and have had sunburn early on in life, so those individuals are very high risk for developing skin cancer and melanoma.
Elizabeth: Let's turn now to the New England Journal of Medicine -- a common problem, really heavy menstrual bleeding secondary to uterine fibroids and a potential treatment.
Rick: Uterine fibroid -- the medical term is leiomyoma -- it's a very common, non-cancerous neoplasm of the uterus. For women that have it, about 50% of them are symptomatic. Sometimes it causes abdominal pain and it's a frequent source of excessive bleeding during menstrual periods and a frequent source of anemia, as well. The typical therapy is to have a hysterectomy or one can actually do uterine artery embolization to try to prevent the bleeding. Many women do not want a hysterectomy or are not interested in an invasive procedure. You can reduce the bleeding by suppressing estrogen.
Now, that obviously has some side effects. So what these authors did was they utilized a gonadal suppressant. It's called elagolix. It inhibits gonadotropin-releasing hormone. It's an antagonist, so it suppresses ovarian sex hormones, and it's been used in endometriosis, so it's already available.
In a randomized controlled trial of almost 800 women that had heavy menses, anemia, due to fibroids, half of them received elagolix and the other half received placebo. It significantly reduced menstrual bleeding, and also in about two-thirds of individuals who were treated with it, actually suppressed it entirely.
Then they had a group that they actually gave a small amount of estrogen replacement to, and that was to try to prevent the mineral loss in the bones that happens with elagolix. They were able to determine in those women that had the elagolix it prevented the menstrual bleeding. But those that got a small dose of estrogen called add-back therapy, they also had suppression of the bleeding, but they didn't have the mineral bone loss. So this is great news.
Elizabeth: Does this also suppress ovulation, because what about if these women are trying to get pregnant?
Rick: Elizabeth, it would suppress ovulation. Now one of the things we always discuss is what are the side effects from it? About 20% of the women had hot flashes associated with it. By the way, if you didn't take the add-back therapy, about 70% of the women had hot flashes, so that's the one side effect. Not serious. It didn't prevent therapy, but obviously was noted by women that were taking the active drug.
Elizabeth: I think this is a moving target. We need a little more experience with this.
Rick: Again, this was only studied over 6 months. You'd like to have a longer period of time. In fact, they're extending it to a 12-month observation and hopefully we'll be able to report on that in the future.
Elizabeth: Okay, so that's your look this week at the medical headlines from Texas Tech. I'm Elizabeth Tracey.
Rick: I'm Rick Lange. Y'all listen up and make healthy choices.