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Reg Wydeven column: Serious risks come with taking testosterone - Post-Crescent

Mark C. Markowski, MD, PhD

In this interview, Mark C. Markowski, MD, PhD, discusses bipolar androgen therapy (BAT), including its advantages and disadvantages, trials that have evaluated the treatment, and what some next steps may include. Markowski is an associate professor of oncology at Johns Hopkins University in Baltimore, Maryland.

We've been doing a lot of work at Johns Hopkins using high-dose testosterone therapies to treat patients with metastatic prostate cancer. It's probably been going on for more than a decade, at least with preclinical studies, and eventually moving into clinical trials. When you treat a patient with metastatic prostate cancer, the backbone of therapy is hormone suppression. We're lowering testosterone levels, trying to get them as low as possible, because testosterone fuels the cancer to grow. When we remove it from the equation, PSA levels go down and that tumor starts to shrink. As a result, patients can live a long time and do very well. But there are also can be a lot of toxicities associated with hormone-based therapies, and so trying to develop non-castrating therapies has been a goal of ours. As I said, when we lower testosterone levels in a patient with metastatic prostate cancer, the cancer will initially respond, but inevitably will become resistantthis is called castration resistance. At the end of the day, even during castration resistance, we think the cancer still wants to signal through the androgen receptor; it still wants to use that testosterone receptor to drive its growth. And it will do so in a number of different ways to get around the testosterone suppression. It can mutate the receptor, it can make more of the receptor, it could splice the receptor so that it doesn't even need testosterone to bind to it anymore, and that cancer will grow. What we've discovered is when you use high-dose testosterone therapy, for lack of a better term, there's just too much electricity flowing through that circuit, and we think we're overwhelming the cancer. By signaling through that testosterone pathway again after potentially years of experiencing a low testosterone environment, this will lead to apoptosis, cell death, and tumor regression. And so, we're trying to take advantage of how it becomes resistant to castration and then really whacking that cancer down by giving it high-dose testosterone therapy that is just too much for the cancer to handle.

We've conducted a number of clinical trials over the years. Initially, we did pilot studies, so very small numbers of patients to test for safety. Weve been treating metastatic prostate cancer with testosterone suppression for the past 80 years. So, when you propose using high-dose testosterone therapies, it can be a bit alarming to move it forward in patients. We did an initial study with etoposide and bipolar androgen therapy. In this trial, it looked like the testosterone therapy by itself worked such that chemotherapy was not necessary. We subsequently moved on to doing different groups of patients, such as patients at different stages of their cancer care. By testing bipolar androgen therapy before and after different novel androgen receptor targeting therapies, we have begun to tease out where bipolar androgen therapy may fit in the treatment paradigm for patients with metastatic prostate cancer? Is it after abiraterone [Zytiga]? Is it after enzalutamide [Xtandi]? After chemo? Where should we employ this kind of testosterone therapy? These questions remain unanswered, but we are getting closer. The largest clinical trial to date was the TRANSFORMER study [NCT02286921], which was a randomized phase 3 study for patients with metastatic castration-resistant prostate cancer after having cancer progression on abiraterone. Patients were randomized to the bipolar androgen vs enzalutamide. The primary end point was radiographic progression-free survival. What we learned from that study was that bipolar androgen therapy certainly works on its own. We can induce clinical responses, PSA decreases, and tumor regression. But when you compare them head-to-head, the results look similar with the enzalutamide. Enzalutamide had similar response rates and a similar radiographic progression-free survival compared to bipolar androgen. It was somewhat disappointing that the primary end point was not met, but when we started to look at secondary end points, we began to better understand that bipolar androgen may prime the tumor to respond to the next line androgen receptor inhibitor. It's not only that the bipolar androgen may work on its own. But it's also that the testosterone therapies may sensitize the patients to other novel androgen receptor targeted therapies. I think when we were designing the TRANSFORMER study, we were looking at testosterone by itself vs enzalutamide by itself. But when we looked at the data, those patients that got testosterone then crossed over to enzalutamide did very well. And there was actually an overall survival benefit when we looked at patients receiving bipolar androgen followed by enzalutamide vs those who just received enzalutamide by itself. That was a secondary end point, so it wouldn't change the standard of care, but at least it was cluing us in to the mechanism here, that it may not just be the bipolar androgen therapy that works, even though it does in certain patients; they do very well. But when they have cancer progression on the testosterone, we really can take advantage of that sensitization effect with next line treatment And so, we may want to prime patients between oral AR-targeted therapies with the testosterone therapy, and I think that was the lesson that we learned from TRANSFORMER.

I think we're still working on that and trying to identify where bipolar androgen therapy would be best suited. We've done a number of trials; like I said, the TRANSFORMER study. We also just completed the COMBAT study [NCT03554317], which was a combination of bipolar androgen with the immune checkpoint inhibitor nivolumab [Opdivo]. The eligibility for the COMBAT study was that patients had to have cancer progression on at least 1 AR-targeted therapy, but there was no limit in number of therapies. And so, we actually got a very heterogeneous population of patients in terms of treatment; some were early phase, early in their clinical disease course, and some were heavily pretreated with a number of oral AR-targeted therapies and even chemotherapies. And so, we got to look at some of the response rates to testosterone therapy in a bunch of different clinical states of prostate cancer. There did not appear to be an advantage of treating early vs later; it seemed like if the testosterone was going to work, it was going to work for however long it was going to work for, irrespective of the number of therapies. So, it's not exactly clear where we should implement it. It seems to work reasonably well wherever we choose to use it. But I think, in a little bit more general terms, mixing in the bipolar androgen after an AR-targeted therapy will sensitize patients to that next line of AR-targeted therapy. We've learned over the years that trying to move from an oral AR-targeted therapy like abiraterone straight to enzalutamide is not the best treatment approach. There should be something in the middle there, whether it's chemotherapy or something else. But that may be a spot where testosterone therapies would become useful to see if we can get you to sensitize to that second AR-targeted therapy.

We're trying to understand that. Conventional wisdom would suggest that the harder you've been targeting that AR-targeted pathway, the more likely you may be to benefit from the testosterone. So, the more pressure you put on the androgen receptor over time, perhaps we can take advantage of giving the bipolar androgen therapy, and that's been our hypothesis. We have not found clear, convincing evidence that the line of AR-targeted therapies will either improve or worsen outcomes. We're looking into that. What we're trying to do now is pool all the patients that we've treated over a number of clinical trials and even off clinical trials to answer this question. If we have 500 to 700 patients with various degrees of prior treatment, we may be able to at least retrospectively get a signal to say, which patients responded best to bipolar androgen. We're trying to figure that out. But I think right now, that's unclear, and we don't have that answer.

That's the million-dollar question right now. We're going over the data from the COMBAT study. The best part about that study is that we took serial biopsies from patients, so we have actual tissue that we can study from before testosterone and during testosterone. We have serial blood draws; we have a lot of time points where we're collecting specimens for patients to try to answer that question. Dr. Laura Sena, Dr. David Sanin, and others have begun to analyze some of that data. I think it's no surprise that when we study the androgen receptor and androgen receptor signaling, we're starting to see a pattern of who's going to respond to bipolar androgen. Its not just in patients who have the highest level of androgen receptor -That doesn't appear to be the case. But the data suggest that those patients that have high signaling through the androgen receptor - so if you can give them a score for androgen signaling, those that had the highest androgen receptor scorehad the best response to testosterone. From a practical perspective, that makes sense; those patients who are heavily dependent on the androgen receptor pathway may see the most benefit using a drug that's clearly hitting the androgen receptor pathway. I think that's what we found so farthat high AR signaling will predict response. We're also finding that bipolar androgen therapy can reduce MYC expression. MYC is a common oncogene in many cancers, not just prostate cancer. We found that those patients who respond deeply to bipolar androgen had very significant declines in MYC protein expression. There are still some pieces to put together there. So I think if I'm going to answer this a little bit more succinctly, patients with tumors that had high AR signaling did better on bipolar androgen, and those that we found had the most robust MYC decrease in protein expression also did very well. The relationship between AR and MYC is there, and we're trying to explore that further.

I think it's received attention. I think people are interested in the topic. The beauty of bipolar androgen is that it's relatively cheap. Injections of testosterone are somewhere in the range of $20 to $30 a month. For cancer treatments, that's remarkably inexpensive. I think there's a cost effectiveness to it. I think it's very safe. And then, in terms of the side effects of bipolar androgen, many of the "side effects are actually positive changes. Hot flashes go away, they have more energy, they get more libido, they can have erections, and this is all during the course of received treatment for metastatic prostate cancer. I think people are interested in it based on the quality-of-life perspective, the cost efficiency of it. But I also think providers need to see concrete data showing that bipolar androgen is superior to whatever cancer treatment that we're comparing it to. I think each trial that we do, we're clearly seeing signal and the treatment seems safe. What we're still trying to identify is what's the right sequence so that we can inform treatment. That kind of parlays into ongoing clinical trials with bipolar androgen. And I think the one trial that I will highlight is the STEP-UP trial [NCT04363164]. This trial involvespatients with metastatic castration-resistant prostate cancer who received prior treatment with abiraterone. They get randomized to 1 of 3 groups. They can go into the enzalutamide-only group, so they go straight from abiraterone to enzalutamide. That was 1 of the control groups in the TRANSFORMER study. And then there are 2 experimental arms. In 1 of these arms, patients get bipolar androgen therapy until progression, and then enzalutamide until progression. The third arm is a kind of flip-flop; patients receive bipolar androgen therapy for a period of time, then enzalutamide, then bipolar androgen and back to enzalutamide. The hope here is that this trial is going to be a more definitive study to really show the benefit of bipolar androgen therapy because TRANSFORMER didn't build that second piece, the enzalutamide treatment, into the primary end point. So if STEP-UP is positive and shows a clear difference vs enzalutamide alone, then I think the way patients with metastatic prostate cancer are treated is going to change. Bipolar androgen will get more attention, and more people are going to do it. I think the other part of this conversation is that there is some concern about providers and patients doing testosterone therapy off label and on their own without clear clinical guidance. It's great to get attention for your work, but we're also a bit concern that providers are just going to do it in patients because testosterone is FDA approved affordable. But we worry about safety and monitoring. How do you follow those patients? It can be a little tricky because we're using testosterone. Testosterone can signal through AR, and those cancers can make more PSA. Well, that rise in PSA may not reflect tumor growth, so do you manage that in patients? It becomes a little bit tricky. We've gotten good experience with managing these patients, like I said, over the past 10 years, sowe kind of know what patterns we're looking for. Whereas if you don't have experience, we just worry about safety. It's a double-edged sword. It's nice to get attention; I think it is getting attention. But we also worry about people going out and doing it without the proper guardrails in place.

As we learn more about mechanism, which we're understanding from the COMBAT study, we're trying to find logical partners to put with bipolar androgen therapy. I think there are 2 directions that we're going in. One is bipolar androgen by itself and the sensitization to other AR therapies story, and I think STEP-UP is going to tell that story. And then there's another direction that is somewhat open endedwhat are logical partners to pair with bipolar androgen? How do we make bipolar androgen therapy work better? Can we figure out a way to keep MYC levels down for longer? Can we pair testosterone with some MYC inhibitor or some suppressor of MYC expression to make it work better? It's possible. Are there other logical pairs of treatments that go with bipolar androgen? Yes, absolutely, and we're trying to figure those out as we go. I think it's a 2-pronged approach. One is the conventional approach, which is STEP-UP. And then as we dig through the data from our prior studies to say what makes sense to pair with bipolar androgen? We are working those out right now.

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Bipolar androgen therapy in prostate cancer: Current evidence and next steps - Urology Times

A recent study published in the journal Psychopharmacology shows that men currently using anabolic-androgenic steroids face challenges in accurately recognizing facial expressions of emotion, especially those of anger and disgust. This effect appears to be more pronounced among individuals with steroid dependence.

Anabolic-androgenic steroids, synthetic variations of the male hormone testosterone, are widely known for their use among athletes and bodybuilders to enhance physical performance and muscle mass. Despite their popularity, anabolic-androgenic steroids come with a host of potential side effects, including significant impacts on mental health and cognitive functions.

Prior studies have associated anabolic-androgenic steroids use with increased aggression, anxiety, depression, and personality disorders. Intriguingly, these behavioral changes may stem from impaired social cognitive functions, such as recognizing and interpreting others emotionsa crucial skill for effective non-verbal communication and empathy.

Motivated by the gap in understanding the specific impact of anabolic-androgenic steroids on emotional recognition, researchers conducted this study to better understand the effects of steroid use and dependence on the ability to recognize facial expressions of emotion accurately. They hypothesized that anabolic-androgenic steroid use would correlate with diminished accuracy in emotional recognition, potentially mediated by altered hormone levels.

Our team has previously investigated the role of anabolic steroids in recognizing emotions from biological movement and theory of mind video tasks, so we were interested in how people who use(d) steroids recognize emotions from facial expressions, said study author Morgan Scarth, a postdoctoral researcher at Oslo University Hospital.

We were also interested if fluctuations in hormone levels could explain any differences in emotional recognition abilities. The ability to recognize and respond to other peoples emotions may have implications for social behaviors.

The study cohort comprised 171 adult men engaged in heavy resistance training, divided into two main groups: those who had used anabolic-androgenic steroids (94 participants) and a control group with no history of steroid use (77 participants). The steroid group was further categorized based on current usage status into those currently using steroids (On) and those who had ceased use (Off).

Participants underwent a comprehensive evaluation including emotional recognition tasks, hormone level measurements, and assessments for anabolic-androgenic steroid dependence. Emotional recognition was tested using a computerized task where participants identified emotions from facial expressions. Hormone levels were analyzed from blood samples, focusing on the serum free testosterone index (FTI) among others.

Men who were currently using steroids demonstrated a significantly lower ability to accurately recognize facial expressions of anger and disgust. This indicates that steroid use may impair individuals capacity to interpret these particular negative emotions, which could have implications for social interactions and communication.

The researchers further identified that individuals with a dependence on steroids showed a worse recognition of fear compared to those without such dependence. This suggests that beyond the general effects of steroid use, developing a dependence on these substances might be associated with additional deficits in social cognition.

The researchers did not find evidence that FTI levels significantly mediated the impact of steroid use on the ability to recognize facial expressions of emotion. This indicates that while testosterone levels are altered by steroid use and correlated with changes in emotion recognition, they do not fully explain the observed deficits in recognizing certain emotions.

Men who are currently using anabolic steroids may have a reduced ability to recognize negative facial emotional expressions, specifically anger and disgust, Scarth told PsyPost. This effect does not seem to be explained by fluctuations in the hormone levels measured in the study. Men who had previously used anabolic steroids but have quit did not seem to have the same deficits, suggesting that this effect may be temporary.

However, the study is not without its limitations. The specificity of the sample all male, heavily involved in resistance training, and primarily Norwegian limits the generalizability of the findings to broader populations, including females and those from other cultural backgrounds. Additionally, the cross-sectional design precludes conclusions about causality, and the presence of unmeasured confounding variables could influence the observed relationships.

The study is cross-sectional, so we cannot make any claims that steroid use causes impaired emotion recognition, Scarth explained. Also, we do not account for the specific types of anabolic steroids used, nor the duration of use or how recently steroids were used prior to completing the emotion recognition task, which may have some impact on social cognitive abilities.

Looking ahead, the research team aims to delve deeper into the neurological impacts of anabolic-androgenic steroids, with a particular focus on how these substances affect brain aging and cognitive functions over time. By unraveling the nuanced ways in which synthetic hormones influence our minds and social lives, this line of inquiry holds the promise of informing more effective interventions for those affected by steroid use and dependence.

The research group is continuing to investigate how anabolic steroids impact the brain and cognition, and is particularly interested in the effects of anabolic steroids on brain aging, Scarth said.

The study, Supraphysiological testosterone levels from anabolic steroid use and reduced sensitivity to negative facial expressions in men, was authored by Morgan Scarth, Lisa Evju Hauger, Per Medbe Thorsby, Siri Leknes, Ingunn R Hullstein, Lars T. Westlye, and Astrid Bjrnebekk.

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Steroid use linked to diminished emotional recognition skills in men - PsyPost

A study published online Dec. 27, 2023, by JAMA Network Open confirms prior research showing that testosterone replacement therapy (TRT) in men with documented low testosterone levels does not increase their risk of prostate cancer compared to men not using TRT.

Researchers recruited 5,246 men with hypogonadism (a condition in which the testes don't produce enough testosterone), no family history of prostate cancer, and prostate-specific antigen (PSA) levels of less than 3 nanograms per milliliter (ng/ml), a number associated with a low risk of prostate cancer. The researchers randomly divided the men into two groups.

For 14 months, the men used either a topical testosterone gel at a dose designed to maintain normal testosterone levels, or an inactive (placebo) gel. Researchers measured PSA levels and conducted digital rectal exams of the prostate at regular intervals over the next three years. By the end of that period, the number of men diagnosed with prostate cancer was equally low in both the testosterone and placebo groups. Those in the TRT group did see their PSA levels rise during the first year of using the gel. However, the increase was small, and PSA levels did not rise again after that, according to the researchers. The testosterone users also reported few symptoms of an enlarged prostate, such as frequent urination, difficulty urinating, and dripping.

The study was limited to men with hypogonadism who had a low risk of prostate cancer, so it's not clear how TRT may affect higher-risk men or those who use testosterone in higher amounts, for longer periods of time, or for treating other conditions.

Image: gorodenkoff /Getty Images

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Appropriate use of testosterone therapy does not appear to raise prostate cancer risk - Harvard Health

Study area

We carried out our field work in the grassland located within the Experiment Demonstration Base, Grassland Research Institute, Chinese Academy of Agricultural Sciences (40 36 N, 111 45 E). This area has a continental temperate monsoon climate, with an average annual rainfall of ca. 400mm and an annual mean temperature of ca. 6.9C. The dominant plant species are Leymus chinensis, Stipa capillata, Cleistogenes squarrosa and Medicago sativa. Based on our own trapping record, S. dauricus has been the dominant rodent species here in recent years. Other rodents, such as striped hamster (Cricetulus barabensis) and Mongolian gerbil (Meriones Unguiculatus), were also recorded but relatively low in abundance. According to our observation, steppe polecats (Mustela eversmanii), red foxes (Vulpes vulpes) and domestic dogs (Canis lupus familiaris) are the major predators feeding on S. dauricus [32]. Cattle grazing is common here in spring and summer, resulting in an average grass height of ca. 20cm and an average vegetation cover of 45%.

In mid-July, 2023, we conducted the first round of live-trapping in two 1-ha sites located in the study area. In this season, most S. dauricus were reproductively inactive. The two sites were comparable in terms of vegetation, topography and rodent density. To ensure independence in sampling among the sites, there was a distance of 400m between the nearest sites. We placed 100 Sherman live traps (arranged in a 1010 grid, with 10-m intervals between neighboring traps) baited with fresh peanuts in each site. Since S. dauricus were diurnal, the traps were set open between 07:00 and 19:00 (Beijing time). This round of live-trapping lasted for four consecutive days. We checked all the traps every 2h and rebaited the traps if needed. All the S. dauricus captured were immediately put in separate cotton bags and taken back to our laboratory.

A total of 59 S. dauricus (27 males and 32 females) were captured during the first round of live-trapping. We anesthetized each individual by a multi-channel anesthesia machine designed for small animals (R550IE, RWD Life Science Co., Ltd., Shenzhen, China) with isoflurane. To collect the ectoparasites, the body surface of each S. dauricus was carefully scanned using a fine-toothed comb and a tweezer. We also checked the inner side of each cotton bag used to contain the ground squirrels. All the ectoparasites collected from a S. dauricus were immediately placed in ethanol (95%) contained within a separate 5-ml centrifuge tube. All the S. dauricus were weighted to the nearest 0.1g using an electronic balance, toe-clipped for individual identification, and then maintained in separate plastic boxes for 72h with access to ad libitum food (peanuts, alfalfa leaves, and commercial pellets) and water. No S. dauricus showed any abnormal behavior or healthy problem during this period.

We used all the 52 adult individuals (defined as those heavier than 100g, 23 males and 29 females) for our formal experiment. Each ground squirrel was randomly assigned to one of two groups: control group (without testosterone injection, 11 males and 14 females) and treatment group (with testosterone injection, 12 males and 15 females). At 15:0016:00 in the next day after capture, we collected a fresh fecal sample (typically 0.20.3g) from each experimental animal. All the fecal samples were placed in separate 5-ml centrifuge tubes and then immediately stored frozen at 80C. About 72h after capture, each individual was injected intramuscularly with either a dose of tea oil (control group) or a dose of testosteroneoil mixture (10mg of testosterone undecanoate per ml of tea oil). A total of 1h after injection, we released all the individuals at the places where they were captured.

A total of 10days later, we conducted the second round (five consecutive days) of live trapping to recapture the experimental animals. The procedures of live-trapping, anesthesia, ectoparasite collection, fecal sample collection, and animal maintenance were similar to the first round. A total of 28 S. dauricus were recaptured (six males and seven females from the control group, and five males and ten females from the treatment group). An experienced taxonomist (Jian-Jun Wang) later identified all the ectoparasites based on dichotomous keys. The whole experimental procedure adhered to the guidelines approved by the American Society of Mammalogists [34] and the Regulations of the Animal Welfare Committee of Beijing Veterinarians of the Agriculture Ministry of China (Beijing, China).

We typically followed the protocol used by Li etal. [35] to extract testosterone from the fecal samples, with some modifications. A total of 56 fecal samples were used for hormone analyses (i.e., samples collected from the 28 individuals with recaptures, two samples per individual). Since we used wet feces, variations in water content among samples must be accounted for. Therefore, we simultaneously weighed two fecal subsamples (each ca. 0.1g in weight, hereafter subsamples A and B) from each fecal sample. Subsample B was used for measuring water content and was weighed before and after 24-h drying in a drying oven. The water content value was then used to translate the wet sample weight of the relevant subsample A into dry weight.

Subsamples A were used for hormone extraction and placed in separate 10-ml centrifuge tubes. For each tube, we added 4ml of methanol and 1ml of distilled water and then vortexed it for 30min. We then added 2.5ml of petroleum ether to each tube to remove lipid from it. After 10min of vortex, each tube was centrifuged at 1500r/min for 15min. A total of 2ml of liquid was drawn from the methanol layer within each tube and then placed into a 5-ml cryopreservation tube. The methanol was dried off under forced air and the remain was used for hormone assay.

We performed testosterone assays with a commercially available enzyme immunoassay kit (Rat Testosterone Elisa Kit, produced by FanYin Biotechnology Co., Ltd., Shanghai, China). This kit has a sensitivity of 1.0 nanomol/l, and<1% cross-reactivity to other steroids (including progestins, corticoids and estrogens). The testosterone levels were reported as nanogram of fecal testosterone per gram of dry feces.

We performed all the statistical work in R platform 4.2.2 [36]. We first adopted a paired-sample t-test to test whether our experimental treatment affected the fecal testosterone level of S. dauricus. We built a negative-binomial generalized linear mixed-effect model (GLMM) on tick load recorded on the recaptured individuals (hereafter TickLoadafter) using the R package lme4 [37] and lmerTest [38]. The fixed terms included treatment (control or treatment group), sex (male or female), body weight (averaged value of the two measurements), tick load recorded in the first round of ectoparasite check (i.e., tick load before the testosterone manipulation, hereafter TickLoadbefore), flea load in the second round of ectoparasite check (hereafter FleaLoadafter), and an interactive term between treatment and sex. Site ID was used as a random term. Similar models were also built for FleaLoadafter, with fixed factors including treatment, sex, body weight, flea load recorded in the first round of ectoparasite check (hereafter FleaLoadbefore), TickLoadafter, and an interaction between treatment and sex. Variance inflation factors (VIFs) were calculated using the R package car [39] to assess multicollinearity. As the VIFs were all smaller than ten (Table1), we retained all the factors in the models. Model selection was performed based on Alkaike Information Criterion corrected for small sample size (AICc) [40] using the R package MuMIn [41]. Since the performance did not differ significantly between top candidate models (i.e., delta AICc smaller than 2), we used conditional model averaging to get an averaged model based on the full set of candidate models [40]. As we detected a significant interactive effect between treatment and sex on TickLoadafter, we also built two GLMMs on TickLoadafter for male and female squirrels separately (Table2). For these two models, the fixed terms included treatment, body weight, TickLoadbefore, and FleaLoadafter.

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Complex effects of testosterone level on ectoparasite load in a ground squirrel: an experimental test for the ... - Parasites & Vectors

Whether youre a competitive athlete, a fitness enthusiast or just looking for a more chiseled physique, you may be tempted to turn to supplements to give your body a muscle-building boost.

So, when you hear about SARMs (selective androgen receptor modulators), you may think youve found the magic bullet.

After all, you think, theyre not really steroids. So, they must be ... somehow ... better for you, right?

Not so fast, says family medicine physician Ayan Sanyal, MD. SARMs are still in the investigational stages by the FDA (the U.S. Food and Drug Administration), so their safety profile and long-term effects havent been well studied. But from what we do know, SARMs have been associated with very major negative impacts across several vital organs in your body.

What exactly are SARMs and what are the risks? Dr. Sanyal shares what we know so far.

SARM stands for selective androgen receptor modulators. Its a category of compounds that affect the androgen receptors in your body.

Lets break that down.

Androgens like testosterone and dihydrotestosterone (DHT) are the sex hormones associated with things like muscle development, bone density, and sexual desire and function, Dr. Sanyal explains.

Everyone has androgens in their bodies. But men and people assigned male at birth (AMAB) make more androgens than women and people assigned female at birth (AFAB).

In order to do their work, androgens need to bind to certain receptors throughout your body. But those receptors arent always fully activated. Thats normal.

SARMs bypass that system. Think of SARMs as a key that unlocks the androgen receptors in your muscles and bones. They open the doors and allow a rush of testosterone and DHT into those areas.

One effect of that is quicker muscle growth, without you having to put in the work of lifting weights. But there are other effects, too. Potentially dangerous ones. More on those in a bit.

SARMs arent technically illegal in the way that nonmedical drugs, like, say, cocaine, are illegal. But it is illegal for companies to market them as dietary supplements. And they cant be prescribed by doctors.

SARMs also are banned by the U.S. Department of Defense, as well as sports organizations, including the NCAA and the World Anti-Doping Agency (WADA).

More than 120 SARM products are on the WADA Prohibited List, which means these products show up as a positive on a drug screening test, even if you havent taken them for a while or dont take them regularly, Dr. Sanyal notes.

Why are SARMs prohibited in sports?

Its two-pronged, really.

One reason is that SARMs can give you a competitive advantage by increasing muscle mass.

The other is because the known risks of SARMs are enough to cause concern.

Supplement manufacturers try to bypass the rules and regulations regarding selling SARMs in some sneaky ways.

One hint that you may be looking at a product that contains SARMs is on the labels disclaimer. Because SARMs arent allowed to be sold as supplements, youll see language on their package to the effect of For research purposes only. Or Not for human consumption.

Or you can review the ingredients label. But know that SARMs go by a number of different names, making them hard to spot in a laundry list of ingredients.

The U.S. Anti-Doping Agency (USADA) says some of the most popular SARMs include:

See the full list of SARMs and other WADA-prohibited substances here.

But beware that no matter what the package claims, youre likely not getting the full story.

The supplement market is highly unregulated, and theres very little quality control, Dr. Sanyal warns. Companies are trying to make a quick buck, and they know that some people will pay for SARMs. So, some of these products want you to think youre getting SARMs, but they may actually be a very low percentage of those compounds. (Good for your health. Bad for your wallet.)

On the other hand, the lack of regulation means your product could have very high even toxic levels of SARMs.

SARMs work like anabolic steroids in that they can encourage quick muscle growth. But how they go about that work is a little different.

SARMs target the specific androgen receptors in your muscles and bones. Anabolic steroids unlock the androgen receptors across your whole body. Research from the National Institutes of Health says that anabolic steroids also create new androgen receptors.

The risks of misusing anabolic steroids have been well-studied and understood for years. They include issues like:

Some people will tell you that because SARMs are choosy about which receptors they unlock, they dont have negative side effects. Or that because they work differently from anabolic steroids, they arent a risk to your health.

But scientific research says otherwise.

More research needs to be done to know more about SARMs effects and their long-term effects, but the preliminary research has raised a number of concerns, Dr. Sanyal shares.

The FDA warns that research to date has connected SARMs with risks and side effects like:

SARMs have yet to be subjected to the high-quality longitudinal studies that need to happen to fully understand their risks and any benefits, he continues. Future research will also be able to tell us more about how SARMs interact with other medications and supplements.

Researchers are also studying the potential to use SARMs medically for people living with severe muscle loss, such as people with age-related muscle wasting, HIV or people whove lost muscle mass due to chemotherapy treatments.

When SARMs came along in the 1990s, they proliferated the market as a safer alternative to steroids.

That idea is going out of style. Because the more we learn, the less safe they appear.

In 2017, the FDA released a statement warning against SARMS, saying, in part, SARMs, have not been approved by the FDA and are associated with serious safety concerns.

The warning goes on to say that the FDA has and will continue to take legal action against companies selling products that contain SARMs.

You're really rolling the dice by taking SARMs because we dont know everything that they do to the body on the biochemical level, Dr. Sanyal warns. Eating a healthy diet with plenty of lean proteins and alternating cardio exercise with weight training is going to be the safer route to building muscle.

And if you think a supplement is the way to go, talk with a healthcare professional about safe and effective options.

Continued here:
SARMs Harmful Side Effects and Risks - Health Essentials

Matthew Trevio and Emily Fletcher are self-described DINKWADs double income, no kids, with a dog. The Sacramento couple, who met and work at UC Davis, are as committed to each other as they are to not having children, which makes reliable birth control especially important. But except for condoms or a vasectomy, all birth control options currently available are for women. Trevio, 35, and Fletcher, 28, believe contraception should be more of a shared responsibility.

Maybe the burden is on the wrong side, said Trevio. I kind of think its unfair, that it only lands on the women.

They have been participating in a clinical trial at UC Davis Health to test a reversible hormonal birth control gel for men. If successful, male hormonal birth control has the potential to make the responsibility of contraception more equitable. The clinical trial, funded by the National Institutes of Health and taking place at sites around the world, is currently in its fourth year at UC Davis Health.

The hormonal gel, developed by the Population Council and the NIH, is applied to the shoulders and works by suppressing sperm production while maintaining testosterone levels. The gel works with the same principles as female hormonal birth control, which uses two hormones progestin and estrogen to prevent pregnancy.

The gel has a progestin called Nesterone, which prevents the testes from making sperm, explained Mitchell Creinin, professor of obstetrics and gynecology and a family planning specialist at UC Davis Health. During that process, natural testosterone production also stops.

For a man to feel normal and even be able to have sex, he needs testosterone. So, we give Nesterone plus testosterone.

Participating in the trial wasnt an easy decision for the couple. Fletcher had been on some form of birth control since age 12. The trial meant going off birth control at a pivotal time just when Roe v. Wade was overturned.

I was worried, said Fletcher. There was still a thought in the back of my mind that maybe this will be an issue if the drug doesnt work and I get pregnant.

Fletcher and Trevio did their homework on the trial and examined the data. They both work as researchers. Ultimately, they both decided it was the right thing for themselves and for their relationship.

The hormonal gel comes in a canister about the size of a can of shaving cream, and it holds two weeks worth of doses. Trevio, a former Marine, has made applying the hormonal gel part of his morning routine, squirting just a small amount on his tattooed shoulders.

The list of possible side effects from the gel is long and includes dry or oily skin, increased or decreased libido, hair growth or loss, and mood swings. Besides what may be a little weight gain from the drug, Trevio has had only one other side effect.

Ive only experienced increased libido, he said. Maybe Im just lucking out but I hope this is the case for the majority of participants. If it is, its definitely going to change contraception as a whole.

Fletcher said shes had to adjust to Trevios increased libido. But she says their sex life comes with a lot less worry.

Knowing that his sperm count is essentially zero is definitely peace of mind, Fletcher said.

Researchers hoped the gel would work about as well as the female birth control pill, but its working even better than expected, said Creinin.

Link:
Male hormonal birth control? It may be closer than you think - University of California

Winnie Jemutai Boinetthas been suspended by the Athletics Integrity Unit (AIU) for three years as she tested positive for testosterone.

Boinetts sample that she provided in competition at the XLI Cross Internacional de Italica in Seville, Spain, on November 12, 2023, had the presence of testosterone. Testosterone is banned under the World Anti-Doping Agencys (WADA) prohibited list.

The 20-year-old 5000-metre runner admitted to the violation and accepted the consequences, including the forfeiture of any medals, titles, points, prize money, and other prizes won since the date of the provisional suspension. Therefore she had a reduced sentence from four years to three years.

The World Anti-Doping Agency (WADA) and the Anti-Doping Agency of Kenya (ADAK) may appeal the decision to the Court of Arbitration for Sport in Lausanne, Switzerland.

The World U20 bronze medallist in the 1500m may have also age-doped as Wikipedia lists her birthday as 4 October 4, 2003, June 4, 2003, or February 9, 2002. She has run the 5000m as fast as 14:39.05.

Original post:
Kenyan Winnie Jemutai Boinett banned three years for testosterone - Athletics Illustrated

ANYONE WHO HAS watched Prime Video's recent hit

The gains came after a call from Skydance Television, the company that coproduces Reacher, that came after season one wrapped, Ritchson revealed in his Men's Health cover story. He had lost too much weight, they told him.

He tried to keep up with his lifting regime while filming, but he was on set nearly seven days a week. It was demanding on his body. By the end of the first season, he was "utterly fatigued and broken," and dealing with an injured shoulder. Luckily, there was a full year-and-a-half break between the two seasons.

A few months into that break, Ritchson's doctor suggested he try testosterone-replacement therapy, or TRT. Testosterone plays a role in hair growth, sex drive, red blood cell production, and (of course) maintenance of muscle mass. TRT is designed to raise testosterone levels in the body for those with low levels of the vital hormone. There are several different kinds, including injectables, topical gels, cream patches, pills, and even nasal spraysall of which come with different side effects.

Ritchson started the therapy under his doctor's supervision, and says it has made growing muscle mass much easier. That doesn't mean he's putting less effort into his time in the gym, though. "People can think what they want, but I work out very hard," he says.

His work has paid off, toohis gains have been well noticed upon his return to the show for season two. Fans have been gawking over his new aestheticsome approving, some not. The more grizzled look works for me much more than it did for the first season, one Redditor wrote. Like he has grown into the role.

And now, that new physique has stirred some buzz about him filling an upcoming superhero rule. Ritchson doesn't care that TRT helped him get to this point though. In his cover story, he joked about someone referencing it as 'steroids with a doctor's note'.

I guess it is, he says now. I didnt even know that it was considered an anabolic steroid to some people. It was just: There was a hormone that was missing for me, and I needed it.

Cori Ritchey, NASM-CPT is an Associate Health & Fitness Editor at Men's Health and a certified personal trainer and group fitness instructor. You can find more of her work in HealthCentral, Livestrong, Self, and others.

Read more from the original source:
Alan Ritchson Opens up About Testosterone Replacement Therapy - Men's Health

T

hanks to his herculean physique, John Cena has enjoyed a decades-long career as a professional wrestler, actor, and rapper. And he has no plans to give up on his gains as he ages.

In a recent interview with Howard Stern, Cena says that hes never taken testosterone replacement therapy (TRT) or anabolic steroids to bulk upbut hes open to the former when his natural testosterone levels start to dip.

Im not ruling (TRT) out. Therell come a time, Cena told Stern. I get my bloodwork done three times a year, and my testosterone is fantastic for a [nearly] 47-year-old.

Cena believes that maintaining healthy testosterone levels promotes longevity and makes it easier to recover post-workout. And hes right. Health professionals suggest theres a link between T levels and lifespan.

While low testosterone may not increase your risk for early death directly all-cause mortality risk increases in men with lower testosterone levels, says James Staheli, D.O.

Conditions linked to low testosterone may be the culprit. Studies show that clinically low T is linked to a higher risk of diabetes, metabolic syndrome, cardiovascular disease, osteoporosis, sexual dysfunction, depression, and dementia (1).

If left unchecked, many of these conditions can limit your healthspan and lifespan.

Research also suggests having a healthy testosterone level for your age] may support skeletal muscle tissue growth, which can help reduce injury risk and help your muscles recover better between workouts (2). Dodging injury and maintaining a healthy amount of muscle can extend your lifespan, too, studies suggest (3).

See original here:
Why John Cena is Considering Testosterone Replacement Therapy - The Edge

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