Category: 8. Health

People with hypothyroidism show significantly higher levels of small intestinal bacterial overgrowth (SIBO) and key bacterial distinctions than those without the thyroid condition, according to results of a study. 

“[The research] supports the idea that improving gut health could have far-reaching effects beyond digestion, possibly even helping to prevent autoimmune diseases, such as Hashimoto thyroiditis,” said senior author Ruchi Mathur, MD, director of the Diabetes Outpatient Treatment and Education Center and director of Clinical Operations of Medically Associated Science and Technology, at Cedars-Sinai in Los Angeles, in a press statement for the study, which was presented at ENDO 2025: The Endocrine Society Annual Meeting. 

“These findings open the door to new screening and prevention strategies,” Mathur added. “For example, doctors may begin to monitor thyroid health more closely in patients with SIBO, and vice versa.” 

With some small studies previously suggesting an association between the gut microbiome and hypothyroidism, Mathur and colleagues further explored the relationship in two analyses.

Assessing the Role of the Small Bowel

For the first, they evaluated data on 49 patients with Hashimoto thyroiditis (HT) and 323 controls without the condition from their REIMAGINE trial, which included small bowel fluid samples from upper endoscopies and DNA sequencing.

In the study, all patients with HT were treated with thyroid replacement (levothyroxine), hence, there were notably no significant differences between the two groups in terms of thyroid stimulating hormone (TSH) levels.

Despite the lack of those differences, patients with HT had a prevalence of SIBO more than twice that of the control group, independent of gender (33% vs 15%; odds ratio, 2.71; P = .005).

When the two groups were further subdivided into two groups each — those with and without SIBO — significant further variations of microbial diversity were observed between those with and without HT, Mathur told Medscape Medical News.

“Interestingly, we saw the small bowel microbiome was not only different in SIBO-positive patients, including higher gram negatives, which is to be expected, but that the presence or absence of hypothyroidism itself was associated with specific patterns of these gram-negative bacteria,” she explained.

“In addition, when we looked at hypothyroidism without SIBO present, there were also changes between groups, such as higher Neisseria in the hypothyroid group.” 

“All these findings are novel as this is the first paper to look specifically at the small bowel,” she added, noting that previous smaller studies have focused more on evaluation of stool samples.

“We believe the small bowel is the most metabolically active area of the intestine and plays an important role in metabolism,” Mathur noted. “Thus, the microbial changes here are likely more physiologically significant than the patterns seen in stool.”

Further Findings from a Large Population

In a separate analysis, the team evaluated data from the TriNetX database on the 10-year incidence of developing SIBO among 1.1 million subjects with hypothyroidism in the US compared with 1 million controls.

They found that people with hypothyroidism were approximately twice as likely to develop SIBO compared with those without hypothyroidism (relative risk [RR], 2.20).

Furthermore, those with HT, in particular, had an even higher risk, at 2.4 times the controls (RR, 2.40).

Treatment with levothyroxine decreased the risk of developing SIBO in hypothyroidism (RR, 0.33) and HT (RR, 0.78) vs those who did not receive treatment.

Mechanisms?

However, the fact that differences in SIBO were observed even between people who were treated for HT and those without the condition in the first analysis, and hence had similar TSH levels, was notable, Mathur.

“This suggests that perhaps there are other factors aside from TSH levels and free T4 that are at play here,” she said.

“Some people have theorized that perhaps delayed gut motility in hypothyroidism promotes the development of SIBO; however, there are many other factors within this complex interplay between the microbiome and the thyroid that could also be playing a role.” 

“For example, SIBO leads to inflammation and weakening of the gut barrier,” Mathur explained.

Furthermore, “levothyroxine absorption and cycling of the thyroid hormone occurs predominantly in the small bowel, [while the] microbiome plays a key role in the absorption of iron, selenium, iodine, and zinc, which are critical for thyroid function.” 

Overall, “further research is needed to understand how the mechanisms are affected during the development of SIBO and hypothyroidism,” Mathur said.

Assessment of Changes Over Time Anticipated

Commenting on the research, Gregory A. Brent, MD, senior executive academic vice-chair of the Department of Medicine and professor of medicine and physiology at the David Geffen School of Medicine at University of California Los Angeles said the study is indeed novel.

“This, to my knowledge, is the first investigation to link characteristics of the small bowel microbiome with hypothyroidism,” Brent told Medscape Medical News.

While any clinical significance has yet to be determined, “the association of these small bowel microbiome changes with hypothyroidism may have implications for contributing to the onset of autoimmune hypothyroidism in susceptible populations as well as influences on levothyroxine absorption in hypothyroid patients on levothyroxine therapy,” Brent said.

With the SIBO differences observed even among treated patients with vs without HT, “it seems less likely that the microbiome changes are the result of reduced thyroid hormone signaling,” Brent noted.

Furthermore, a key piece of the puzzle will be to observe the microbiome changes over time, he added.

“These studies were at a single time point [and] longitudinal studies will be especially important to see how the association changes over time and are influenced by the treatment of hypothyroidism and of SIBO,” Brent said.

The authors and Brent had no disclosures to report.

Limited healthcare access and sociostructural factors were stronger predictors of HIV than behavioral risk factors among Black women in the southern United States, based on modeling data from more than 300,000 women in or near Atlanta, Georgia. The findings were presented in a late-breaker study at the International AIDS Society Conference on HIV Science. 

Nonbehavioral factors such as structural and social determinants of health can complicate HIV risk assessment, wrote Meredith Lora, MD, of Emory University, Atlanta, and colleagues. Previous risk prediction models have underperformed in Black women, whose HIV risk is approximately 20 times that of White women, the researchers wrote.

To better assess HIV risk in Black women, the researchers used machine learning to create a model that analyzed electronic medical records data from all women treated at a single center in Atlanta between 2012 and 2022. The study population included 333,263 women; 617 (0.19%) had incident HIV diagnoses and 89% of those with HIV identified as Black individuals.

The model included features with a prevalence of 5% or higher in the electronic medical records data and included novel structural determinant features and healthcare utilization features.

Overall, the top predictors of HIV included younger age, Black race, residing in high HIV incidence zip codes, and at least one change in phone number or address prior to HIV diagnosis. In addition, women who underwent more HIV screening tests were more likely to be diagnosed with HIV, and women with HIV were more likely than those without HIV to seek care in an emergency department (ED) vs primary care or women’s healthcare settings. Although more women with HIV tested positive for sexually transmitted infectious compared to those without HIV in the 2 years before diagnosis, “seeking sexual health was more important to the model than STI positivity,” the researchers wrote.

The model achieved a test area under the receiver operating characteristic curve (AUROC) of 0.90 and area under a precision-recall curve (AUPRC) of 0.14.

The appearance of frequent HIV testing as a predictor of risk suggests the presence of undisclosed risk factors that may merit further investigation, the researchers noted in their abstract. 

EHR models designed for racially diverse female populations may identify more candidates for pre-exposure prophylaxis (PrEP), but that is not enough, the researchers emphasized. “Evaluating how these models are implemented to support PrEP uptake and behavior change is critical for real-world impact,” they concluded. 

Assistance in Risk Assessment

The current study is important given the traditional and historical difficulty of women in the United States in predicting their own risk of HIV, said Monica Gandhi, MD, director of the University of California San Francisco Bay Area Center for AIDS Research, and a professor of medicine at UCSF, in an interview. 

Gandhi cited a recent study from the CDC showing that more than 2.2 million individuals in the US need PrEP, but only 336K have received prescriptions. “Women may not be able to adjudicate their own risk of HIV, as that risk depends on the risk in their male sexual partners,” said Gandhi, who was not involved in the current study or the CDC study. 

“Machine learning using electronic medical records [EMR] can make risk prediction more accurate by reporting both health and social factors,” she noted. The current study identified predictors of HIV risk using extracted EMR data, that the healthcare system may be able to mitigate, she said.

“I was surprised by the fact that seeking sexual health was a stronger predictor of HIV than STD positivity, which indicates that women actually are more aware of their risk for HIV in the US than suggested in previous studies that usually involved smaller sample sizes, Gandhi told Medscape Medical News. “I was also surprised that women with frequent changes in address or phone number had higher risk,” she said. This suggests mobility as a risk factor, which has been identified more commonly in sub-Saharan Africa, she noted. However, Gandhi was not surprised by the preference for ED care or the increased HIV risk among Black women vs other races, both of which have implications for HIV prevention, she said. 

The preference for sexual health care in the ED setting in the study population suggests that the ED is an important setting in which to perform STD testing and start PrEP or set up an individual with HIV prevention services, said Gandhi. “Designated PrEP services for women in historically Black neighborhoods are indicated, and women who are mobile and change their address or phone number frequently should be counseled on HIV prevention modalities, specifically PrEP,” she added.

Looking ahead, qualitative research is needed to ask a subset of women with HIV who presented to the ED for sexual health services why they chose the ED; this could help inform how to re-engage women in care, Gandhi said. Additional research on women’s knowledge of PrEP and whether women with HIV were offered PrEP in the past also would help identify more opportunities for HIV prevention, she said.

The study was supported by the Emory Medical Care Foundation and statistical analysis was supported by the National Center for Advancing Translational Sciences. Lora disclosed research support from Viiv Healthcare through funds paid to Emory. Gandhi had no financial conflicts to disclose.

A high-level panel discussion convened at the 13th International AIDS Society Conference on HIV Science (IAS 2025) in Kigali, Rwanda drew together representatives from global funding foundations, national health ministries, and advocacy and research organisations to debate the future of HIV PrEP in Africa in the wake of the drastic cuts to US funding.

While all panellists acknowledged the scale of the challenge facing the continuation of PrEP and HIV prevention programmes, the session adopted a constructive and at times even optimistic note on how the ‘PrEP crisis’ could be an opportunity to recast provision so it fits the needs of people at risk of HIV better and more economically.

The session dealt with the issue of how the momentum towards long-acting PrEP drugs could be maintained – which will be covered in another article – but dealt with much broader issues of PrEP provision, in particular how to deliver it in a way truly aligned with public health programmes rather than with medical ones.

Co-chair Mitchell Warren, Executive Director of AVAC, said that a previous campaign aim of AVAC had been to “make PrEP famous”. But “perhaps PrEP has never reached its true potential because it’s been too complicated, being built on a treatment model.” He summed up the session by saying that the aim should now be to “make PrEP simple.”

The implications of the PrEP cuts

Warren acknowledged that if none of the PrEP funding that PEPFAR had been providing was replaced, models showed that global HIV incidence in adults could quadruple, from one case in 200 people a year to one case in 50 by 2030.

Yet he also pointed out the irony that the US cuts had come at a time of an “innovation pile-up”. By mid-2027, generic two-monthly cabotegravir and six-monthly lenacapavir injections will likely be available, along with four-monthly patented cabotegravir and yearly patented lenacapavir. Soon after, in early 2028, monthly oral PrEP in the shape of Merck’s MK-8527 could arrive. “We have squandered opportunities in HIV prevention and treatment before,” he said. “Let’s not waste these ones.”

Due to a huge expansion in PrEP provision by PEPFAR between 2020 and 2022, the US programme ended up providing 90% of the world’s PrEP; by 2024, 8.6 million people had ever initiated PrEP, and 2.75 million started it that year. PEPFAR has not disappeared but is now concentrating on treatment and restricting PrEP to pregnant and breastfeeding women. How can other funders and governments make up the gap?

How do we plan for PrEP after PEPFAR? The government official

Professor Lloyd Mulenga is Director of Infectious Diseases at the Zambia Ministry of Health. He said: “Despite good treatment programmes that should also act as prevention, we still have 23 to 33,000 new infections a year, so we have to argue for prevention as a specific line in the state budget. I do not think it is entirely the fault of politicians that access to, for instance, cabotegravir has been a problem.”

Donor funding, he said, tends to be treated separately from the budgeting done by the finance ministries of his and many other countries – so much so that until a few years ago there was no budget line devoted to HIV prevention in the state budget, and that resulted in lack of prioritisation, and especially lack of prioritising the technical will to ensure there was access to PrEP. He had ensured there was a line in this year’s Zambian health budget costing the introduction of lenacapavir PrEP, even though it likely would not arrive for at least another year.

As he considered which PrEP options to prioritise, it’s been important to consider whether they can be provided by the ‘lower cadres’ such as peer navigators, educators, community advisors. These were the people crucial to delivering PrEP, for instance, to young people, who were not going to approach medical facilities for HIV prevention.

And cost can’t be ignored. “If you have something costing $20 and another which can do the same job costing $5,” it’s hard for governments to justify using the former. “We need to look at what is cheaper, what is reasonable to give our people.”

The health researcher

Professor Saiqa Mullick is implementation director of the Wits Reproductive Health and HIV Institute in South Africa, a country that already pays for its own oral PrEP. Referring to the new options of cabotegravir and lenacapavir PrEP, she agreed that: “We need to balance choice with pragmatism; right now we are sitting with a couple of products that are unaffordable to most governments.”

She suggested several ways of economising PrEP delivery.

“In future we will need more routine monitoring instead of expensive research studies, which implies smarter programmatic monitoring systems,” she said. This will help us understand people’s preferences, and how that affects uptake, in real world settings. “Understanding, for example, whether a product that requires attending three- or six-monthly appointments is easier or more difficult to adhere to for people with busy lives who may migrate for work.” She agreed with Professor Mulenga that there needed to be innovation in service delivery: “PrEP has to be delivered locally in an equitable way”.

The health policy advocate

Imelda Mahaka is director of the health consultancy Pangaea Zimbabwe, which campaigns for better and more equitable health coverage in that country and has influence with its health ministry.

She said that the process of licensing drugs for PrEP was still too slow, singling out the European Medicines Agency for its approach to licensing. “We need fast-track approvals. Why would you need to stop the clock, go back to the manufacturers and wait for a response to restart the whole process?”

In the main, however, she agreed with the previous speakers that the delivery of PrEP is still overly medicalised: “It’s odd that people think it’s OK to flood health facilities with people who are well,” she said.

She also recommended local facilities staffed with “peer navigators and community PrEP champions instead of nurses,” and said there is too much caution and too many layers of staff people had to go through to get PrEP: “You have to see a health educator and then a nurse who walks you through different products.”

Like other speakers, she welcomed the announcement at the conference by the World Health Organization of its new PrEP guidance; not only because it now recommended injectable lenacapavir, but that it recommended simplified oral rapid tests for people using PrEP, and also that PrEP services should be “bundled” into services that PrEP users may want. For instance, a young woman who needs PrEP may also need contraception and STI services, and perhaps pregnancy services. But who will pay for these services?

“I think the money is there within our countries,” she said, “We have a national AIDS fund – but what other resources can we use such as blended public/private partnerships?”

“In the last two weeks,” she added, “Zimbabwe has been looking at a minimum core package of services for HIV, TB and other conditions. Now is not the time to fight for a product. Now is the time to look at the evidence for what works and prioritise.”

The funders

Hui Yang, Head of Supply Operations for the Global Fund agreed, saying it was a challenge “to translate ‘political will’ into actual policies” and that a community-centred approach was essential. PrEP programmes tended to be standalone, not well connected to pre-existing testing and treatment programmes.

The weaknesses of the current programmes were demonstrated by the fact that when some drug supplies were restored, the local infrastructure was not restored too: “We don’t want the product to sit in warehouses waiting to be distributed and implemented.”

There had to be more innovative healthcare structure, including public/private sector partnerships and widespread paid and voluntary community involvement, she said. The feasibility of public/private partnerships was supported by an audience member who noted that “betting shops, churches and alcohol shops all grow rich in Africa” and recommended setting up some healthcare services as social enterprises.

If countries and funders use the present crisis to innovate, she said, “I think we should see the first delivery of lenacapavir PrEP into at least one country within the first quarter of 2026.”

Dr Yogan Pillay, Director of HIV & TB Delivery for the Gates Foundation said that Global Fund and Gates support had to be regarded as ‘catalytic’ rather than foundational. He mentioned MK-8527, the monthly oral PrEP pill that might be available by 2028 and said we needed to be devising access programmes for that now, and planning how to integrate it into injectable and daily oral PrEP.

“Bundling PrEP programmes into, for example, family planning services is entirely feasible,” he said, “but you’d need to be looking at wholesale health innovation, and that’s a model we’d be interested in funding.” He thought AI could be used to model specific solutions.

More comments

Charles Brown, an AVAC Fellow and PrEP advocate from Uganda, asked the panel the ‘elephant in the room’ question of how to get PrEP to criminalised and stigmatised populations, including gay and bisexual men and trans women in his own country, with its notorious anti-gay legislation.

Lloyd Mulenga acknowledged it was difficult if countries budgeted for services to a general population without acknowledging the special needs of key populations, and that “accessing the usual service points might be very difficult.” But he added that local authorities may be able to provide venues that community service organisations could use to create safe spaces, such as offering support for LGBT+ people within youth services. In this way, funding for key populations can continue to be provided under more general budget lines.

“But,” he added, “we do need to make sure that safe spaces are more available.”

Closing the session, Mitchell Warren commented: “We’ve spent the first 40 years in HIV on treatment. But prevention is not just what you do after you get everyone treated. In the next 40 years can we be as ambitious for prevention?”

After the AVAC session, aidsmap spoke to Remko van Leeuven, strategic advisor for Aidsfonds, a funding organisation based in the Netherlands.

“I think the session was highly constructive,” he said. “It’s encouraging to see key stakeholders stepping forward with concrete commitments, even as we continue to grapple with several unresolved questions.

“Lloyd Mulenga’s candid remarks from the Zambian Ministry of Health were particularly valuable I thought. His openness about what approaches work – and don’t work – from a political standpoint provided crucial insights that I think will benefit everyone’s implementation strategies.

“It’s genuinely encouraging to see multiple African governments now incorporating both HIV cure research and lenacapavir roll-out as a central pillar of their national AIDS strategies, signalling a significant shift in how the continent is approaching long-term HIV response planning.”

Nearly one out of every four patients with Long Covid (LC) had cardiac involvement findings on positron emission tomography/magnetic resonance imaging (PET/MRI) that were suggestive of myocarditis, according to a new prospective study.

For the study, recently published in the Journal of Nuclear Medicine, researchers examined imaging data for 98 patients (median age of 48.5) who had persistent cardiopulmonary symptoms nine to 12 months after initial COVID-19 infection. The study authors noted that 91 patients had PET/MRI scans, and 70 patients had dual-energy computed tomography (DECT). The study included a nine-patient control group who had a history of severe acute respiratory syndrome (SARS) with COVID-19 infection but did not have cardiopulmonary symptoms.

The study authors noted that 57 percent of patients had abnormal PET/MRI findings with 30 percent demonstrating aortic or pulmonary vascular uptake. In contrast to the control group that had no myocardial, pericardial or periannular uptake on PET/MRI scans, 24 percent of those with PET/MRI abnormalities had cardiac involvement suggestive of myocarditis and 22 percent had uptake suggesting possible pericarditis, according to the study authors. They added that 11 percent of the cohort had periannular uptake on PET/MRI scans.

“The imaging findings correlated with different serum biomarker profiles between LC and control subjects. This observation suggests that LC patients with long-term cardiopulmonary symptoms have a distinct plasma protein profile. Moreover, significant differences in plasma protein levels were observed between LC patients with normal and those with abnormal PET/MRI, supporting the hypothesis of specific humoral and immune mechanisms underlying pleiotrophic LC manifestation,” wrote lead study author Maria Giovanna Trivieri, M.D., an associate professor of cardiology, heart failure and cardiac transplantation with the Mount Sinai Health System in New York, and colleagues.

The researchers pointed out that 90 percent of the cohort had abnormalities on DECT. Pulmonary infiltrates were evident on DECT for 67 percent of patient and 59 percent demonstrated abnormal perfusion on DECT, according to the study authors. They noted a higher prevalence of these findings among patients with myocardial and pericardial involvement.

“Abnormal DECT was found in 100% of participants with myocardial involvement and periannular uptake and in 79% and 73% of subjects with pericardial involvement and vascular uptake. Subjects with myocardial involvement had the highest rates of infiltrates (71%) and abnormal perfusion (65%) followed by the group with periannular uptake, where 60% had pulmonary infiltrates and 60% had abnormal perfusion,” added Trivieri and colleagues.

Three Key Takeaways

1. Cardiac Involvement common with Long Covid. Approximately 24 percent of patients with Long Covid and persistent cardiopulmonary symptoms showed PET/MRI findings suggestive of myocarditis, and 22 percent showed possible pericarditis, highlighting a significant rate of cardiac involvement.
2. High prevalence of DECT abnormalities. Ninety percent of patients demonstrated abnormalities on dual-energy CT (DECT), particularly pulmonary infiltrates and perfusion defects. These were most common in those with myocardial or pericardial involvement.
3. Potential link between imaging findings and heart failure risk. Patients with abnormal PET/MRI findings had a trend toward increased heart failure risk (odds ratio 3.4), suggesting these imaging markers may serve as potential risk indicators for heart failure in Long Covid, though the study was underpowered to confirm statistical significance.

Clinical follow-up revealed that nine percent of the cohort had heart failure (HF) with myocardial and pericardial involvement frequently noted in abnormal PET/MRI findings that occurred in 78 percent of these patients.

“These results suggest a trend for future HF events based on abnormal PET/MRI with an odds ratio of 3.4, although statistical significance was not reached in this cohort … These findings additionally indicate that the presence of myocardial and pericardial involvement on PET/MRI could serve as a potential risk marker for HF in the LC population,” posited Trivieri and colleagues.

(Editor’s note: For related content, see “New Meta-Analysis Details Most Common Brain MRI Findings with COVID-19,” “New CT Angiography Study Shows Impact of COVID-19 on Coronary Inflammation and Plaque” and “MRI Long Covid Study Reveals Link Between Lower Pulmonary Gas Exchange and Cognitive Dysfunction.”)

In regard to study limitations, the authors acknowledged the relatively small cohort and a lack of statistical power to assess possible connections between cardiopulmonary findings and post-COVID symptoms. They also conceded a possible patient selection bias with the majority of the cohort being self-referred to a pulmonologist or cardiologist.

Dublin, July 22, 2025 (GLOBE NEWSWIRE) — The “Leptomeningeal Metastases Market – A Global and Regional Analysis: Analysis and Forecast, 2025-2035” report has been added to ResearchAndMarkets.com’s offering.

The market for leptomeningeal metastases therapies is evolving rapidly, driven by increasing incidence rates and significant unmet clinical needs. As systemic cancer treatments improve, patients are living longer, leading to a higher prevalence of CNS metastases, including leptomeningeal metastases. For example, advancements in targeted therapies and immunotherapies for primary tumors have extended survival but also increased the risk of CNS involvement, thereby expanding the population requiring specialized leptomeningeal metastases treatments. This dynamic is particularly notable in cancers such as non-small cell lung cancer (NSCLC) and HER2-positive breast cancer, where leptomeningeal metastases incidence is rising.

Current treatment modalities, including intrathecal chemotherapy and radiotherapy, provide limited efficacy and are often associated with substantial toxicity. Systemic therapies historically struggled to penetrate the blood-brain barrier (BBB), limiting their utility against LM. This challenge has spurred intense pharmaceutical innovation focusing on agents capable of crossing the BBB and targeting tumor cells within the leptomeningeal space. The development pipeline includes small molecule tyrosine kinase inhibitors (TKIs) such as osimertinib (targeting EGFR mutations) and tucatinib (targeting HER2), which have demonstrated CNS activity and are being evaluated specifically for leptomeningeal metastases indications. Additionally, antibody-drug conjugates (ADCs) and novel immunotherapies are being investigated for their potential to provide more effective and less toxic treatment options.

The increasing application of precision medicine is another pivotal market driver. Molecular profiling of both primary tumors and CNS metastases enables biomarker-guided therapies, improving patient selection and therapeutic outcomes. Enhanced diagnostic techniques, including advanced imaging and CSF liquid biopsies, facilitate earlier detection and more accurate monitoring of leptomeningeal metastases, enabling timely intervention.

Despite these advances, several challenges temper market growth. The blood-brain barrier remains a formidable obstacle, restricting drug delivery to the leptomeningeal space. Tumor heterogeneity and the diverse biological microenvironment of leptomeningeal metastases complicate treatment responses. Furthermore, the rarity and complexity of leptomeningeal metastases limit large-scale clinical trials, slowing the generation of robust efficacy data and regulatory approvals.

Regulatory agencies have recognized leptomeningeal metastases as an area of high unmet need, often granting accelerated approval pathways and orphan drug designations to promising therapies, which incentivizes investment and innovation. Pharmaceutical companies are increasingly forming strategic collaborations and consortia to pool resources and expertise to tackle the unique challenges posed by leptomeningeal metastases.

The leptomeningeal metastases market is rapidly evolving, driven by several key trends that are reshaping treatment approaches. A major trend is the development of CNS-penetrant targeted therapies, such as osimertinib by AstraZeneca which effectively cross the blood-brain barrier to combat metastatic tumor cells in the leptomeninges. Alongside this, there is growing investment in antibody-drug conjugates (ADCs) and immunotherapies, like the development of CNS-active ADCs, which aim to selectively target cancer cells while reducing systemic toxicity. The increasing use of precision medicine and biomarkers is enabling earlier diagnosis and patient-specific treatment strategies, improving outcomes.

Regulatory agencies are encouraging greater inclusion of leptomeningeal metastases patients in clinical trials, exemplified by expanded trials for drugs, which help generate robust data in this underserved population. Furthermore, strategic collaborations between pharmaceutical companies and biotech firms are accelerating innovation and drug development. In addition, companies are expanding access to emerging markets through tailored pricing and distribution, aiming to meet the rising global burden of leptomeningeal metastases. These trends collectively point to a more precise, effective, and accessible therapeutic landscape for leptomeningeal metastases.

Key Topics Covered:

1. Global Leptomeningeal Metastases Market: Market Outlook
1.1 Industry Outlook
1.1.1 Market Overview
1.1.2 Epidemiological Analysis of Leptomeningeal Metastases, By Region
1.1.3 Regulatory Landscape of Leptomeningeal Metastases Market
1.1.3.1 Legal Requirement and Framework in the U.S.
1.1.3.2 Legal Requirement and Framework in the E.U.
1.1.3.3 Legal Requirement and Framework in Japan
1.1.3.4 Legal Requirement and Framework in Rest-of-the-World
1.1.4 Key Trends
1.1.5 Clinical Trial Analysis
1.2 Market Dynamics
1.2.1 Impact Analysis
1.2.2 Market Drivers
1.2.3 Market Restraint
1.2.4 Market Opportunities

2. Global Leptomeningeal Metastases Market, by Region, $Million, 2023-2035
2.1 Overview
2.2 North America
2.2.1 Key Market Participants in North America
2.2.2 Business Drivers
2.2.3 Business Challenges
2.2.4 Market Sizing and Forecast
2.2.4.1 North America Leptomeningeal Metastases Market, by Country
2.2.4.1.1 U.S.
2.3 Europe
2.3.1 Key Market Participants in Europe
2.3.2 Business Drivers
2.3.3 Business Challenges
2.3.4 Market Sizing and Forecast
2.3.4.1 Europe Leptomeningeal Metastases Market, by Country
2.3.4.1.1 Germany
2.3.4.1.2 U.K.
2.3.4.1.3 France
2.3.4.1.4 Italy
2.3.4.1.5 Spain
2.4 Asia-Pacific
2.4.1 Key Market Participants in Asia-Pacific
2.4.2 Business Drivers
2.4.3 Business Challenges
2.4.4 Market Sizing and Forecast
2.4.4.1 Asia-Pacific Leptomeningeal Metastases Market, by Country
2.4.4.1.1 Japan
2.5 Rest-of-the-world
2.5.1 Key Market Participants in Rest-of-the-world
2.5.2 Business Drivers
2.5.3 Business Challenges
2.5.4 Market Sizing and Forecast

3. Global Leptomeningeal Metastases Market: Competitive Landscape and Company Profiles
3.1 Competitive Landscape
3.1.1 Key Developments and Strategies
3.1.1.1 Funding Activities
3.1.1.2 Mergers and Acquisitions
3.1.1.3 Regulatory Approvals
3.1.1.4 Partnerships, Collaborations and Business Expansions
3.2 Company Profiles
3.2.1 Plus Therapeutics
3.2.1.1 Overview
3.2.1.2 Product Portfolio
3.2.1.3 Target Customers
3.2.1.4 Key Personnel
3.2.1.5 Analyst View
3.2.2 AstraZeneca
3.2.3 AngioChem
3.2.4 Y-mAbs Therapeutics

For more information about this report visit https://www.researchandmarkets.com/r/ufxkc7

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This pesto, egg and potato skillet is a flavorful meal made with just five ingredients thanks to a generous spoonful of pesto, which adds an herby richness. The eggs can easily be cooked to your liking. If you prefer the yolks cooked through, add a few extra minutes to the cook time in Step 3. Garnish with basil, if desired.

Among over-the-counter (OTC) products for depression, St. John’s wort, saffron, probiotics, and vitamin D have the strongest evidence of efficacy, new research showed.

However, folic acid and lavender also show promise and should be prioritized in future research, the investigators noted.

As more patients turn to OTC products to manage depressive symptoms, it’s important to answer questions about the state of the related research, study investigator Rachael Frost, PhD, Senior Lecturer in Health and Social Care, School of Public and Allied Health, Liverpool John Moores University, Liverpool, England, who is herbal practitioner, told Medscape Medical News.

Frost said her team aimed to map the current evidence base for OTC products for depression — asking whether research has focused too narrowly on a few supplements, whether other promising options are being overlooked, and how future studies and consumer guidance could be better directed.

The findings were published online on July 15 in Frontiers in Pharmacology.

Mapping the Research

The prevalence of major depressive disorder (MDD) ranges from 2% to 21%, depending on the country and the measures used, and rates continue to rise — prompting some experts to describe depression as a growing epidemic.

Many patients are reluctant to take antidepressants and face long wait times for psychological therapies, said Frost. “There’s a strong drive for people to self-manage, particularly if they have mild or moderate symptoms of depression,” she noted.

Part of a larger project summarizing existing evidence on OTC products — including herbal medicinal products (HMPs), vitamins and minerals, and homeopathic preparations — for depression, anxiety, and insomnia, the goal of the current review was to “map” the full research landscape on OTC products for depression in adults aged 18-60 and identify gaps where further study is needed, said Frost.

The review included 209 trials assessing 64 different products. Most studies were conducted in Iran, followed by Germany, the US, Australia, the UK, and China.

Double-blind designs were the most common. Sample sizes varied widely, with a median of 62 participants per study.

All trials used depression rating scales as either primary or secondary outcomes. The most frequently used were the Hamilton Depression Rating Scale, the Montgomery-Aberg Depression Rating Scale, and the Clinical Global Impression Scale.

Dietary supplements were evaluated in 114 trials, HMPs in 94 trials, and one trial — outside these categories — investigated aspirin.

Evidence Gaps

In the HMP category, most studies focused on products in capsule form. Frost found this somewhat surprising given the popularity, affordability, and ease of incorporating herbal teas into daily life. She suggested the lack of research on teas may be due to practical challenges — such as the difficulty of creating a placebo tea for controlled trials.

Notably, none of the studies evaluated homeopathic products for depression.

“Homeopathic trials just focused on well–being, rather than looking at people who had symptoms or a diagnosis of depression,”saidFrost.

Few studies examined multivitamins, which can be challenging to evaluate due to varying combinations of vitamins, minerals, and sometimes added herbal extracts or probiotics, Frost explained.

Dietary supplements were more often compared to placebo (86%) than HMPs (67%), whereas HMPs were more frequently compared to prescription drugs (32%) than dietary supplements (5%). Additionally, supplements were more likely to be tested as adjuncts to other depression treatments, most commonly antidepressants — compared to HMPs.

Very few studies evaluated OTC products vs psychotherapy. This, said Frost, is despite psychological therapies being “quite popular” and often a first–line treatment for depression.

“Whether psychological therapies are better than OTC products or if there would be additive effects if people take both at the same time, is a question that needs answering,” she said.

Products With Potential

Products supported by evidence from more than 10 trials included St. John’s wort, saffron, probiotics, and vitamin D. Within these categories, a variety of products, extracts, and dosages were tested.

Most studies on St. John’s wort favored its use compared with placebo and showed effects comparable to or better than prescription antidepressants. While the evidence for St. John’s wort is strong, caution is advised due to potential interactions with antidepressants, contraceptive pills, and other medications, said Frost.

Saffron products also showed generally positive effects compared with placebo. When evaluated alongside antidepressants, saffron demonstrated similar benefits and could be a promising new option to recommend, said Frost.

Results for both probiotics and vitamin D favored the intervention compared with placebo.

“Given that probiotics and vitamin D also might provide benefits for things like the gut, bone health, and immunity, they are probably worth recommending,” Frost noted.

Potential mechanisms by which these OTC products may alleviate depressive symptoms include reducing inflammation, mitigating oxidative stress, modulating the microbiota-gut-brain axis, suppressing hyperactivity of the hypothalamic-pituitary-adrenal axis, and regulating neurotransmitter activity.

The review included several trials on omega-3 supplements, most comparing them to placebo. Frost noted that these studies were more likely to report null findings, indicating that omega-3 may not be a strong recommendation for depression.

Among products with emerging evidence (two to nine trials), the review identified folic acid, lavender, zinc, tryptophan, rhodiola, and lemon balm as the most promising. Bitter orange, Persian lavender (Nepeta menthoides), and chamomile each showed positive results in two trials.

These promising products, Frost said, warrant further evaluation to better understand their potential benefits.

While some emerging OTC products show promise, Frost cautions that their effectiveness is not guaranteed. She stresses the importance of doctors having open, honest discussions with patients to ensure any supplements do not interfere with existing health conditions or medications.

The study on aspirin showed no evidence of efficacy for depression.

Many trials lacked sufficient safety data; however, among those that reported safety outcomes, most products demonstrated a favorable safety profile, Frost noted.

Experts Weigh In 

Commenting on the research for Medscape Medical News, Jonathan Burgess, MD, clinical assistant professor at Lifestyle Psychiatry Clinic, Stanford University, in Stanford, California, said the review gives him “quite a bit of homework,” as he plans to examine several of the original studies.

However, he pointed out that the review did not differentiate between eicosapentaenoic acid (EPA)-predominant and docosahexaenoic acid-predominant omega-3 formulations.

Contrary to the review’s suggestion that omega-3s are ineffective for depression, Burgess noted that multiple meta-analyses have shown that EPA-predominant formulas are convincingly effective for depression.

He said that beyond advising a healthy diet, regular exercise, and good sleep hygiene, EPA-predominant omega-3s, St. John’s wort, saffron, and probiotics are his “go-to’s” for patients with depression who want to try OTC treatments.

Burgess agreed that lavender and folate show considerable promise but cautioned that, like any effective treatment, they can have side effects. He cited cases where patients overused lavender and experienced suicidal thoughts, warned that excessive zinc intake can disrupt copper balance, and highlighted the risk of serotonin syndrome—a potentially life-threatening condition — in patients taking tryptophan alongside St. John’s wort.

Also commenting for Medscape Medical News was David Mischoulon, MD, PhD, director of the Depression Clinical and Research Program at Massachusetts General Hospital and professor of Psychiatry at Harvard Medical School, both in Boston, who has extensively researched natural remedies.

He said the review offers a useful snapshot of the current state of the field and aligns with his overall understanding of the evidence base.

However, he questioned why the review included so few studies on S-adenosyl-methionine (SAMe), a compound involved in the synthesis of neurotransmitters such as serotonin, dopamine, and norepinephrine. The review cited only two parallel randomized controlled trials on SAMe, one of which he coauthored.

“I’m surprised because it’s one of the better studied natural products. The review seems to underestimate how much has been done with regard to that particular product,” said Mischoulon.

Mischoulon said he is “a lot more comfortable” recommending SAMe for patients with depression than many other OTC products, largely due to its strong safety profile. Aside from occasional nausea or indigestion at higher doses, SAMe is generally well tolerated. Unlike St. John’s wort — which can interact with immunosuppressants, antiretrovirals, cancer therapies, antidepressants, and hormonal contraceptives — SAMe does not interact with other medications, he noted.

In addition to SAMe, Mischoulon also considers omega-3 supplements a viable OTC option for depression.

However, he emphasized the importance of directing future research toward emerging products. He noted that well-studied options like St. John’s wort and omega-3s have already been thoroughly reviewed and suggested that greater attention should be given to lesser-known supplements such as lavender and folic acid.

Frost and Burgess reported no relevant disclosures. Mischoulon reported receiving research support from Nordic Naturals and Heckel Medizintechnik GmbH. He works with the MGH Clinical Trials Network and Institute, which has received research funding from multiple pharmaceutical companies.