Fluoxetine Enhances Visual Acuity in Adults with Amblyopia Under Patching: Study

Researchers have found that fluoxetine improves visual acuity significantly in adults with amblyopia under standard patching therapy. A new study was recently published in the Journal of AAPOS conducted by Arash M. and colleagues .

This was a randomized clinical trial conducted among adults aged 18 years or older diagnosed with anisometropic or strabismic amblyopia. Prior to intervention, all the participants were given standard amblyopia treatment in terms of glasses and patching for four months. Thereafter, they were randomized into two groups as follows:

  • Fluoxetine Group: Given fluoxetine 20 mg/day for three months with continuation of patching.

  • Placebo Group: Provided with a placebo for three months with continuation of patching.

  • Baseline and after the treatment period, visual acuity and VEP parameters were measured.

The total number of participants that completed the study was 55, with 29 in the fluoxetine and 26 in the placebo group. The average age of the participants was 27.2 ± 8.6 years, ranging between 18 and 54 years.

Key Findings

Visual Acuity Improvement:

  • In the fluoxetine group, mean change in logMAR visual acuity was 0.20 ± 0.24 (range: 0-0.8) (P < 0.001).

  • For the placebo group, this was 0.08 ± 0.15 (range: 0-0.7) (P = 0.01).

  • The difference in favour of the fluoxetine treatment group was significantly higher than for the placebo treatment group with a P-value of 0.04.

  • By the end of the study, the mean visual acuity in the fluoxetine group was 0.36 ± 0.21 logMAR, better than that in the placebo group, which was 0.43 ± 0.35 logMAR.

Visual-Evoked Potential Parameters:

  • N75 amplitude changes did not reach significance in both groups compared with baseline. However, the difference between the two groups was statistically significant (P = 0.05).

  • N135 latency significantly improved within the fluoxetine group compared with baseline (P = 0.03).

Fluoxetine treatment significantly improved visual acuity and certain VEP parameters in adults undergoing patching for amblyopia. This study underscores fluoxetine’s potential to augment standard treatments for amblyopia in adults, offering new hope for effective management of this condition.

Reference:

Mirmohammadsadeghi, A., Mousavi, A., Akbari, M. R., Khojasteh, H., Masoomian, B., Sadeghi, M., Yadegari, S., & Asadigandomani, H. (2024). Fluoxetine as a possible treatment for adult amblyopia: results of a double-blind, randomized, placebo-controlled trial. Journal of AAPOS, 28(5), 104009. https://doi.org/10.1016/j.jaapos.2024.104009

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Obstetric co-morbidity index may predict maternal morbidity and need for transfer to better maternal care facility: Study

The obstetric comorbidity index (OBCMI) is a tool aimed at evaluating obstetric risk based on existing maternal and obstetric conditions. Patients receive scores reflecting their comorbidities, which are then totaled to create a numerical value. Initially developed for risk adjustment in extensive database analyses, the OBCMI has been commonly applied in research to characterize the acuity of study. Recent study conducted by McCarter et al. aimed to assess the relationship between the obstetric co-morbidity index (OBCMI) and severe maternal morbidity (SMM) in antepartum obstetric transfers to a Level IV maternal care facility. The study included antepartum transfers to a single Level IV maternal care facility from January 2016 to December 2020, focusing on deliveries that occurred during the same encounter. The OBCMI scores were retrospectively collected by manual chart review, and SMM was determined through ICD-10 and CPT code extraction confirmed by reviewers.

Correlation Between OBCMI and SM

Among the 561 transfers meeting the inclusion criteria, the study found a significant correlation between OBCMI and SMM. The median OBCMI was higher for transfers with maternal-only indications compared to fetal-only indications. The prevalence of SMM was notably different based on the indication for transfer. An OBCMI cutoff score of ≥ 4 was identified with high sensitivity (81%) in predicting SMM and was associated with adverse outcomes such as operative delivery, blood transfusion, ICU admission, prolonged hospitalization, and reoperation.

OBCMI Discrimination for SMM in Transfers

The study demonstrated that OBCMI could discriminate for SMM in obstetric transfers to a Level IV maternal care facility, especially for those transferred for maternal indications. However, the ability of OBCMI as a predictive tool decreased when stratifying transfers for fetal-only indications. The proposed OBCMI cutoff of ≥ 4 showed promising specificity and sensitivity in predicting SMM, indicating its potential usefulness in triaging obstetric patients for appropriate care.

Potential Value of OBCMI in Obstetric Transfer

Overall, the study highlighted the potential value of OBCMI as a tool to identify pregnant patients at a higher risk of SMM and adverse obstetric outcomes, particularly for antepartum transfers to Level IV maternal care facilities. The findings suggest that further validation and refinement of OBCMI, possibly through newer techniques like machine learning, could enhance its effectiveness as a predictive tool for ensuring risk-appropriate maternal care and triaging obstetric transfers effectively. Further studies are recommended to validate the OBCMI cutoff and assess its applicability across diverse populations and health systems.

Key Points

1. The study by McCarter et al. investigated the relationship between the obstetric co-morbidity index (OBCMI) and severe maternal morbidity (SMM) in antepartum obstetric transfers to a Level IV maternal care facility from January 2016 to December 2020. OBCMI scores were obtained through manual chart review, and SMM was confirmed using ICD-10 and CPT codes.

2. A significant correlation was found between OBCMI and SMM among the 561 transfers meeting the inclusion criteria. Higher OBCMI scores were observed in transfers with maternal-only indications compared to fetal-only indications. An OBCMI cutoff score of ≥ 4 showed high sensitivity (81%) in predicting SMM and was linked to adverse outcomes like operative delivery, blood transfusion, ICU admission, prolonged hospital stay, and reoperation.

3. OBCMI was found to effectively discriminate for SMM in antepartum transfers to a Level IV maternal care facility, especially in cases transferred for maternal indications. However, the predictive capability of OBCMI decreased when transfers were stratified for fetal-only indications. The proposed cutoff of ≥ 4 displayed promising specificity and sensitivity in predicting SMM, indicating its potential for effective triage of obstetric patients.

4. The study underscored the potential value of OBCMI in identifying pregnant patients at higher risk of SMM and adverse obstetric outcomes, particularly in antepartum transfers to Level IV maternal care facilities. It suggested further validation and refinement of OBCMI, possibly through advanced techniques like machine learning, to improve its efficiency as a predictive tool for ensuring appropriate maternal care and effective triage of obstetric transfers

5. The findings emphasize the importance of validating the OBCMI cutoff and evaluating its generalizability across different populations and health systems to enhance its utility in clinical practice. This implies that OBCMI could serve as a useful tool for risk assessment and management in antepartum transfers, aiding in the provision of tailored care for pregnant patients with heightened risks of SMM.

6. In conclusion, the study by McCarter et al. highlights the significance of OBCMI in predicting SMM in antepartum obstetric transfers to Level IV maternal care facilities and suggests the potential for its further development and integration into clinical practice to improve outcomes for pregnant patients at elevated risk of severe maternal morbidity.

Reference –

McCarter, A.R., Theiler, R.N., Branda, M.E. et al. The obstetrics comorbidity index as a predictive tool for risk-appropriate maternal care. BMC Pregnancy Childbirth 24, 797 (2024). https://doi.org/10.1186/s12884-024-06992-

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Even low levels of arsenic in drinking water raise kidney cancer risk: Study

New research findings from the Texas A&M University School of Public Health indicate that exposure to even low levels of arsenic poses significant health risks, including an increased risk of kidney cancer.

The incidence of kidney cancer in the United States rose by an average of 1.2 percent each year between 2011 and 2019 to become the seventh most common cancer. In the meantime, smoking-a well-established risk factor for kidney cancer-has continued to decline.

This led researchers to consider other possible contributing factors, including arsenic, a known cause of various cancers that is naturally occurring in groundwater in Texas and other areas. Unlike previous studies, the Texas A&M study focused on low levels of arsenic exposure (below the regulatory threshold of 10 parts per billion) in both public water systems, which are regulated by various government agencies, and private well systems, which are not regulated.

“Some public water systems are poorly managed and could expose customers to arsenic, but the 40 million people in the United States who rely on private wells are particularly vulnerable,” said Taehyun Roh, with the Department of Epidemiology and Biostatistics.

Others involved with the study were Daikwon Han, Xiaohui Xu, and then-doctoral student Nishat Tasnim Hasan, with the Department of Epidemiology and Biostatistics, and Garett Sansom, with the Department of Environmental and Occupational Health. The project was supported by grants from the Houston Methodist Research Institute, Robert and Janice McNair Foundation and National Institute of Environmental Health Sciences.

Their findings, published in Environmental Pollution, examined the relationship between kidney cancer rates and arsenic levels in drinking water across 240 Texas counties. The team analyzed cancer data from the Surveillance, Epidemiology, and End Results on 28,896 cases of cancer among adults in Texas aged 20 and older, alongside water testing data from the Texas Department of State Health Services and the Texas Water Development Board.

They used a statistical model that accounts for geographic location and adjusted the model for demographic and socioeconomic factors and cancer risk factors such as obesity, smoking and diabetes. They also adjusted for covariates that included pesticide density, social vulnerability, income level, rurality, cardiovascular disease hospitalization rates and the prevalence of chronic kidney disease.

The analysis found that exposure to between 1 and 5 parts per billion raised kidney cancer risk by 6 percent, and exposure above 5 parts per billion raised the risk by 22 percent. In addition, the risk of cancer increased by 4 percent with each doubling of water arsenic levels.

“This suggests that even low-level arsenic exposure in drinking water may be associated with an increased risk of kidney cancer, which aligns with previous research indicating an association between this exposure and lung, bladder and skin cancers,” Roh said.

Hasan noted that their study design can indicate associations between factors but not causality and recommended that future studies focus on individual-level and biometric data -rather than the county-level data used here-to better assess the effects of factors such as lifestyle, family history of kidney cancer and other possible sources of arsenic exposure.

“Still, our findings indicate that reducing arsenic exposure could reduce the incidence of kidney cancer, and this could be achieved through efforts such as enhanced regulatory oversight and targeted public health interventions,” Hasan said.

Reference:

Nishat Tasnim Hasan, Daikwon Han, Xioahui Xu, Garett Sansom, Taehyun Roh, Relationship between low-level arsenic exposure in drinking water and kidney cancer risk in Texas, Environmental Pollution,https://doi.org/10.1016/j.envpol.2024.125097.

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Fragmented nocturnal sleep linked to development of MASLD, suggests study

The prevalence of MASLD (metabolic dysfunction-associated steatotic liver disease) is exploding in most regions of the world, boosted by increased obesity and sedentary lifestyles. MASLD (formerly known as non-alcoholic fatty liver disease) is already the most common liver disorder: it affects 30% of adults and between 7% and 14% of children and adolescents, and this prevalence is predicted to rise to more than 55% of adults by 2040. People with MASLD run a heightened risk of diabetes, hepatocellular carcinoma, non-liver cancers, chronic kidney disease, age-related muscle loss, and cardiovascular disease.

Earlier studies have implicated disturbances in the circadian clock and in the sleep cycle in the development of MASLD. But the American Academy of Sleep Medicine has recommended that objective measures – rather than subjective ones such as sleep questionnaires – be used to prove this hypothetical link between disorders of sleep and the circadian rhythm, MASLD, and MASH. MASH is a more severe form of MASLD, where the liver suffers damage from inflammation and tissue scarring, caused by abnormal accumulation of fat.

“Here we show for the first time with an objective method, 24/7 actigraphy, that the sleep-wake rhythm in patients with MASLD does indeed differ from that in healthy individuals: those with MASLD demonstrated significant fragmentation of their nightly sleep due to frequent awakenings and increased wakefulness,” said Dr Sofia Schaeffer, a postdoctoral researcher at the University of Basel and Basel’s University Center for Gastrointestinal and Liver Diseases, and the corresponding author of a new study in Frontiers in Network Physiology.

Actigraphy involves tracking gross motor activity with a sensor worn on the wrist.

Don’t lose any sleep

Between 2019 and 2021, Schaeffer and colleagues recruited 46 adult women and men diagnosed with either MASLD, MASH, or MASH with cirrhosis. A further eight patients with non-MASH-related liver cirrhosis served as comparisons, while a second comparator group consisted of 16 age-matched healthy volunteers. Each study participant was equipped with an actigraph, to be worn at all times, which tracked light, physical activity, and body temperature.

Participants visited the clinic as outpatients at the start, midpoint, and end of the four-week follow-up. Both at the start and end of this period, they underwent clinical investigation, were interviewed through sleep questionnaires about their sleep habits. They also kept a sleep diary.

All patients with MASLD were obese, and 80% had metabolic syndrome. Patients with MASLD further had significantly higher levels of triglycerides, fasting glucose, and insulin in their blood than healthy participants, but lower levels of total cholesterol, ‘bad’ LDL cholesterol, and ‘good’ HDL cholesterol.

Rude awakening

Actigraph measurements didn’t reveal any differences between patients with MASLD and healthy participants when it came to things such as sleep duration or the amount of time spent in bed.

But importantly, the actigraphs showed that patients with MASLD woke 55% more often at night, and lay 113% longer awake after having first fallen asleep, compared to healthy volunteers. Patients with MASLD also slept more often and longer during the day. Sleep patterns and quality as measured by actigraph were similarly impaired in patients with MASH, MASH with cirrhosis, and non-MASH-related cirrhosis.

Subjectively, patients with MASLD self-reported their disrupted and inefficient sleep as shorter sleep with a delayed onset. In their sleep diaries, 32% of patients with MASLD reported experiencing sleep disturbances caused by psychological stress, compared to only 6% of healthy participants.

“We concluded from our data that sleep fragmentation plays a role in the pathogenesis of human MASLD. Whether MASLD cause sleep disorders or vice versa remains unknown,” said Schaeffer.

“The underlying mechanism presumably involves genetics, environmental factors, and the activation of immune responses – ultimately driven by obesity and metabolic syndrome.”

Schaeffer and colleagues also tried to improve the sleep of participants with a single sleep hygiene education session, performed at the study’s midpoint. Here, they were taught practical measures to improve their sleep habits. However, the results showed that the session didn’t improve the actigraphy or self-reported measures of sleep quality and quantity.

“A single sleep hygiene education session didn’t suffice to sustainably impact on the circadian rhythm in either patients with MASLD or healthy controls. Future studies should explore perpetual sleep counselling sessions or interventions such as light therapy in combination with other lifestyle changes to improve the sleep-wake cycle in patients with MASLD,” recommended Dr Christine Bernsmeier, a professor at the University of Basel and the study’s senior author.

Reference:

Sofia Schaeffer, Significant nocturnal wakefulness after sleep onset in metabolic dysfunction–associated steatotic liver disease, Frontiers in Network Physiology, https://doi.org/10.3389/fnetp.2024.1458665

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Conduct phase III clinical study on resistant hypertension: CDSCO Panel tells Sun Pharmaceutical Industries on Esaxerenone

New Delhi: Responding to the proposal presented by the drug major Sun Pharmaceutical Industries to manufacture and market the drug Esaxerenone tablets 2.5 mg and 5 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct a phase III clinical study on resistant hypertension.

This came after Sun Pharmaceutical Industries presented the proposal to manufacturer and market Esaxerenone tablets along with a request for grant of permission to conduct a phase III clinical trial and deliberations of comparative bioavailability before the committee.

Esaxerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) used to treat hypertension and diabetic nephropathies.

Esaxerenone is a selective, potent, and long-lasting nonsteroidal mineralocorticoid receptor antagonist developed on the basis of dihydropyridine calcium channel blockers such as felodipine and nimodipine, which have mineralocorticoid receptor blocking properties.

The committee deliberated in detail that esaxerenone tablets (2.5 mg and 5 mg) are not indicated for essential hypertension as per the guidelines.

The committee noted that another applicant has been recommended for grant of permission to conduct a Phase III clinical trial of the same drug with the indication of resistance hypertension.

In line with the above, the committee reviewed and requested the firm that the BE study conducted for export purposes be submitted along with the bioequivalence (BE) study protocol for further review.

In addition to the above, regarding the phase III protocol presented by the firm on essential hypertension, which was reviewed by the committee, the expert panel opined that the firm needs to conduct a phase III clinical study on resistant hypertension and submit the protocol accordingly to the committee.

Also Read: Zydus barred from selling cancer drug Sigrima as Delhi HC restores injunction in favour of Roche

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Five ways to make your daily walks even more beneficial

Physical activity doesn’t need to be complicated. Even just a brisk, ten-minute daily walk can deliver a host of health benefits—lowering the risk of several diseases, including heart disease, stroke and several cancers.

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Bright light may lower depression symptoms by promoting better sleep

Why might more time in the sun boost a person’s mood? A new study led by investigators at Brigham and Women’s Hospital, a founding member of the Mass General Brigham health care system, suggests that sleep may hold the key. The study, which included more than 6,600 participants, found that participants who spent more time in bright light had more regular sleep, and more regular sleep was associated with lower depression symptoms and lower odds of mild or severe depression. Results are published in JAMA Network Open.

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A sickle cell first: Base editing, a new form of gene therapy, leaves patient feeling ‘more than fine’

Though he doesn’t remember it, Branden Baptiste had his first sickle cell crisis at age 2. Through elementary school, he was in and out of the hospital with pain episodes, not knowing why. As he got older, he learned he had sickle cell disease. His red blood cells were forming sickle shapes and getting stuck in his blood stream, preventing oxygen from reaching his tissues.

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Keto diet metabolite may power up CAR T cells to kill cancer

A simple dietary supplement may provide a new approach to boost CAR T cell function, according to a study by researchers in the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine’s Abramson Cancer Center. While the approach needs to be assessed in clinical trials, the early research, shared in a press briefing at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, hints at a potentially cost-effective strategy to improve CAR T cell function and cancer-fighting abilities.

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Global clinical trial shows improved survival rates for common childhood leukemia

Just days before his fourth birthday, Santiago was diagnosed with B-cell acute lymphoblastic leukemia (B-ALL), the most common cancer in children. He began chemotherapy the next day, and the outlook was promising—disease-free survival rates for B-ALL are among the highest for pediatric cancers, at 80 to 85%. However, limited progress has been made over the last 15 years, and relapsed B-ALL remains a leading cause of cancer death among children.

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